Metastatic Breast CancerPhase 1/2Morpheus-panBCNCT03424005
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
A Phase 1/2 study testing Capecitabine, Atezolizumab and Ipatasertib in people with Metastatic Breast Cancer, run by Hoffmann-La Roche at 55 sites in 9 countries.
Trial summary
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Capecitabine, Atezolizumab and Ipatasertib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,132 participants
- Where
- 55 sitesin 9 countries
- Study dates
- 30 Mar 2018to 30 Sep 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):
- Age >/= 18 years at the time of signing Informed Consent Form
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Able to comply with the study protocol, in the investigator's judgment
- Metastatic or inoperable locally advanced adenocarcinoma of the breast
- Measurable disease (at least one target lesion) according to RECIST v1.1
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- Life expectancy >/= 3 months, as determined by the investigator
- Tumor accessible for biopsy, unless archival tissue is available
- Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Who cannot join
- Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds
- Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
- Eligibility only for the control arm
- Exclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort)
- Adverse events from prior anti-cancer therapy that have not resolved to Grade </= 1 or better with the exception of alopecia of any grade and Grade </= 2 peripheral neuropathy
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- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Uncontrolled tumor-related pain
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- Significant cardiovascular disease
- Prior allogeneic stem cell or solid organ transplantation
- History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Trial locations and contacts
55 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: CO40115 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
55 sites in 9 countries
United States26 sites, 14 recruiting
- Recruiting
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee, 37404
- Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43212-3117
- Recruiting
City of Hope - Duarte
Duarte, California, 91010
- Completed
City of Hope
Duarte, California, 91010
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710-2000
- Recruiting
The West Clinic
Germantown, Tennessee, 38138
- Withdrawn
Hackensack Univ Medical Center
Hackensack, New Jersey, 07601
- Withdrawn
Regional Cancer Care Associates, LLC
Howell Township, New Jersey, 07731
- Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
- Recruiting
University of California San Diego (UCSD) - Koman Family Outpatient Pavilion ? La Jolla
La Jolla, California, 92093-1350
- Completed
University of California San Diego Medical Center
La Jolla, California, 92093
- Completed
Rocky Mountain Cancer Center - Longmont
Longmont, Colorado, 80501
- Recruiting
UCLA Health 200 Medical Plaza
Los Angeles, California, 90004
- Recruiting
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
- Withdrawn
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
- Withdrawn
NYU Langone Medical Center
New York, New York, 10016
- Recruiting
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy
Omaha, Nebraska, 68130
- Withdrawn
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
- Withdrawn
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
- Withdrawn
Texas Oncology-Plano East
Plano, Texas, 75075-7787
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502-1576
- Recruiting
Metro-Minnesota Community Oncology Research Consortium
Saint Paul, Minnesota, 55101-2502
- Withdrawn
Stanford Cancer Institute
Stanford, California, 94305
- Completed
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, 33612
- Recruiting
City of Hope® Cancer Center Chicago
Zion, Illinois, 60099
Israel7 sites, 7 recruiting
- Recruiting
Rambam Medical Center
Haifa, 3109601
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
- Recruiting
Hadassah University Medical Center
Jerusalem, 91120
- Recruiting
Rabin MC
Petah Tikva, 55900
- Recruiting
Sheba Medical Center
Ramat Gan, 5262100
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
- Recruiting
Assuta Medical Centers
Tel Aviv, 69710
South Korea5 sites, 5 recruiting
- Recruiting
National Cancer Center Clinical Trials Center / Center for Breast Cancer
Goyang-si, 410-769
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
Spain5 sites, 5 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
- Recruiting
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Centro Integral Oncológico Clara Campal Ensayos Clínicos START
Madrid, 28050
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41009
France4 sites, 2 recruiting
- Completed
Centre Léon Bérard
Lyon, 69008
- Withdrawn
Institut régional du Cancer Montpellier
Montpellier, 34298
- Recruiting
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, 31059
- Recruiting
Gustave Roussy
Villejuif, 94805
Australia2 sites, 2 recruiting
- Recruiting
Peter MacCallum Cancer Centre-East Melbourne
Melbourne, Victoria, 3000
- Recruiting
Fiona Stanley Hospital - Medical Oncology
Murdoch, Western Australia, 6150
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
- Recruiting
Universitätsklinikum Essen
Essen, 45147
Taiwan2 sites, 2 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704302
- Recruiting
National Taiwan University Hospital
Taipei, 100
United Kingdom2 sites
- Completed
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
- Completed
Barts Health NHS Trust - St Bartholomew's Hospital
London, EC1A 7BE
About this study
Official title: A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.
The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study:
Read more
Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort).
Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naïve cohort).
Cohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations.
Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).
In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Capecitabine, Atezolizumab, Ipatasertib, SGN-LIV1A, Bevacizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called RO0091978
Capecitabine will be administered 1250 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day cycle.
AtezolizumabDrug
Also called RO5541267
For Atezolizumab + SGN-LIV1A, Atezolizumab + Sacituzumab Govitecan, or Atezolizumab + Chemo arms: atezolizumab will be administered intravenously (IV), 1200 mg, on Day 1 of each 21-day cycle.
For Atezolizumab + Nab-Paclitaxel, Atezolizumab + Selicrelumab + Bevacizumab, Atezolizumab + Ipatasertib, or Atezolizumab + Nab-Paclitaxel + Tocilizumab arms: atezolizumab will be administered IV, 840 mg on Days 1 and 15 of each 28-day cycle.
IpatasertibDrug
Ipatasertib will be administered by mouth 400 mg once a day, on Days 1-21 of each 28-day cycle.
SGN-LIV1ADrug
Also called RO7235441, Ladiratuzumab vedotin
SGN-LIV1A will be administered IV, 2.5 milligrams per kilogram (mg/kg) (maximum calculated dose 250 mg), on Day 1 of each 21-day cycle.
BevacizumabDrug
Bevacizumab will be administered IV, 10 mg/kg, on Days 1 and 15 of each 28-day cycle.
Chemotherapy (Gemcitabine + Carboplatin or Eribulin)Drug
Gemcitabine will be administered by IV, 1000 mg/m^2, along with carboplatin, by IV, on Days 1 and 8 of each 21-day cycle.
Or
Eribulin will be administered IV, 1.4 mg/m^2 on Days 1 and 8 of each 21-day cycle.
SelicrelumabDrug
Selicrelumab will be administered by subcutaneous (SC) injection, at a fixed dose of 16 mg on Day 1 of Cycles 1 to 4 and every third cycle thereafter (Cycle = 28 days).
TocilizumabDrug
Also called RO4877533
Tocilizumab will be administered IV, 8 mg/kg on Day 1 of each 28-day cycle.
Nab-PaclitaxelDrug
Also called RO0247506
Nab-Paclitaxel will be administered IV, 100 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.
Sacituzumab GovitecanDrug
Also called RO7445735
Sacituzumab govitecan will be administered by IV infusion, 10 mg/kg, on Days 1 and 8 of each 21-day cycle.
AbemaciclibDrug
Also called RO7071651
Abemaciclib tablets will be administered at a dose of 150 mg twice daily by mouth on Days 1-28 of each 28-day cycle.
FulvestrantDrug
For Inavolisib + Abemaciclib + Fulvestrant, Inavolisib + Ribociclib (Dose #1) + Fulvestrant, Inavolisib + Ribociclib (Dose #2) + Fulvestrant, or Inavolisib + Atirmociclib + Fulvestrant arms:
Fulvestrant 500 mg, administered as an IM injection on Days 1 and 15 of Cycle 1, followed by Day 1 of each 28-day cycle thereafter.
For Empa + Inavolisib + Fulvestrant ± Palbociclib, or Metformin + Inavolisib + Fulvestrant ± Palbociclib arms:
Fulvestrant 500 mg, administered as an IM injection on Day 1 and as per local prescribing guidelines thereafter.
Ribociclib (Dose #1)Drug
Also called RO7072612
Ribociclib tablets will be administered by mouth once daily.
Inavolisib (Dose #1)Drug
Also called GDC-0077, RO7113755
Inavolisib tablets will be administered by mouth once daily.
Trastuzumab DeruxtecanDrug
Trastuzumab Deruxtecan will be administered IV, 5.4 mg/kg on Day 1 of each 21-day cycle.
Ribociclib (Dose #2)Drug
Also called RO7072612
Ribociclib tablets will be administered by mouth once daily.
LetrozoleDrug
Letrozole tablets will be administered at a dose of 2.5 mg once a day by mouth on Days 1-28 of each 28-day cycle.
Inavolisib (Dose #2)Drug
Also called GDC-0077, RO7113755
Inavolisib tablets will be administered by mouth OD.
EmpagliflozinDrug
Empagliflozin, administered orally, once daily (QD)
PalbociclibDrug
For Empagliflozin + Inavolisib + Fulvestrant ± Palbociclib arm:
Palbociclib 125 mg administered orally, QD in Cycle 1 followed by 125 mg on Days 1-21 of each cycle.
For Metformin + Inavolisib + Fulvestrant ± Palbociclib arm: Palbociclib 125 mg administered orally, QD in Cycle 1, followed by 125 mg on Days 1-21 of each cycle (Cycle=28 days).
MetforminDrug
Metf 1000 mg administered orally QD.
AtirmociclibDrug
Atirmociclib administered orally, BID on Days 1-28 for each 28-day cycle.
GiredestrantDrug
Giredestrant 30 mg will be administered by mouth once daily, on Days 1-28 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab + Nab-Paclitaxel | Active comparator | 1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus nab-paclitaxel until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Nab-Paclitaxel |
| Atezolizumab + Nab-Paclitaxel + Tocilizumab | Experimental | 1L PD-L1-positive participants will receive combination treatment with atezolizumab plus nab-paclitaxel and tocilizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Enrollment is closed and participant follow-up is complete. Receives: Drug: Atezolizumab; Drug: Tocilizumab; Drug: Nab-Paclitaxel |
| Atezolizumab + Sacituzumab Govitecan | Experimental | 1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus sacituzumab govitecan until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Sacituzumab Govitecan |
| Capecitabine | Active comparator | 2L CIT-naïve participants will receive capecitabine until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1).
Participants who progressed on treatment may have the option of receiving atezolizumab along with chemotherapy (chemo) during stage 2, provided they meet the eligibility criteria.
Enrollment is closed and participant follow-up is complete. Receives: Drug: Capecitabine |
| Atezolizumab + Ipatasertib | Experimental | 2L CIT-naïve participants will receive doublet combination treatment with atezolizumab plus ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria.
Enrollment is closed and participant follow-up is complete. Receives: Drug: Atezolizumab; Drug: Ipatasertib |
| Atezolizumab + SGN-LIV1A | Experimental | 2L CIT-naïve participants will receive doublet combination treatment with atezolizumab plus SGNLIV1A until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Patients who experience loss of clinical benefit as determined by the investigator or unacceptable toxicity related to SGN-LIV1A will be given the option of receiving Atezolizumab + chemo during Stage 2, provided they meet the eligibility criteria.
Enrollment is closed and participant follow-up is complete. Receives: Drug: Atezolizumab; Drug: SGN-LIV1A |
| Atezolizumab + Selicrelumab + Bevacizumab | Experimental | 2L-CIT-naïve participants will receive doublet combination treatment with atezolizumab plus selicrelumab and bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria.
Enrollment is closed and participant follow-up is complete. Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Selicrelumab |
| Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin) | Experimental | 2L CIT-naïve participants enrolled in the active comparator arm who experience disease progression per RECIST v1.1 and 2L CIT-naïve participants enrolled in an experimental arm who experience loss of clinical benefit as determined by the investigator may receive doublet combination treatment with atezolizumab plus chemo (gemcitabine + carboplatin or eribulin) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Enrollment is closed and participant follow-up is complete. Receives: Drug: Atezolizumab; Drug: Chemotherapy (Gemcitabine + Carboplatin or Eribulin) |
| Inavolisib (Dose #2) + Abemaciclib + Fulvestrant | Experimental | HR+ participants will receive treatment with inavolisib plus abemaciclib plus fulvestrant until unacceptable toxicity or disease progression determined by the investigator according to RECIST v1.1. Receives: Drug: Abemaciclib; Drug: Fulvestrant; Drug: Inavolisib (Dose #2) |
| Inavolisib (Dose #2) + Ribociclib (Dose #1) + Fulvestrant | Experimental | HR+ participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Fulvestrant; Drug: Ribociclib (Dose #1); Drug: Inavolisib (Dose #2) |
| Inavolisib (Dose #2) + Ribociclib (Dose #1) + Letrozole | Experimental | HR+ participants will receive treatment with inavolisib plus ribociclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Ribociclib (Dose #1); Drug: Letrozole; Drug: Inavolisib (Dose #2) |
| Inavolisib (Dose #2) + Ribociclib (Dose #2) + Fulvestrant | Experimental | HR+ participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Fulvestrant; Drug: Ribociclib (Dose #2); Drug: Inavolisib (Dose #2) |
| Inavolisib (Dose #2) + Ribociclib (Dose #2) + Letrozole | Experimental | HR+ participants will receive treatment with inavolisib plus ribociclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Ribociclib (Dose #2); Drug: Letrozole; Drug: Inavolisib (Dose #2) |
| Inavolisib (Dose #2) + Abemaciclib + Letrozole | Experimental | HR+ participants will receive treatment with inavolisib plus abemaciclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Abemaciclib; Drug: Letrozole; Drug: Inavolisib (Dose #2) |
| Inavolisib (Dose #1) + Trastuzumab Deruxtecan | Experimental | HER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Enrollment is closed. Receives: Drug: Inavolisib (Dose #1); Drug: Trastuzumab Deruxtecan |
| Inavolisib (Dose #2) + Trastuzumab Deruxtecan | Experimental | HER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Enrollment is closed. Receives: Drug: Trastuzumab Deruxtecan; Drug: Inavolisib (Dose #2) |
| Empagliflozin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib | Experimental | Participants with locally advanced or metastatic, HR+, HER2- participants will receive empagliflozin plus inavolisib plus fulvestrant with or without palbociclib until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Fulvestrant; Drug: Inavolisib (Dose #2); Drug: Empagliflozin; Drug: Palbociclib |
| Metformin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib | Experimental | Participants with locally advanced or metastatic, HR+, HER2- participants will receive metformin plus inavolisib plus fulvestrant with or without palbociclib until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Fulvestrant; Drug: Inavolisib (Dose #2); Drug: Palbociclib; Drug: Metformin |
| Inavolisib (Dose #2) + Atirmociclib (Atirmo) + Fulvestrant | Experimental | Participants will receive inavolisib plus atirmociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Fulvestrant; Drug: Inavolisib (Dose #2); Drug: Atirmociclib |
| Inavolisib (Dose #1) + Abemaciclib + Letrozole | Experimental | HR+ participants will receive treatment with inavolisib plus abemaciclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Abemaciclib; Drug: Inavolisib (Dose #1); Drug: Letrozole |
| Inavolisib (Dose #1) + Abemaciclib + Giredestrant | Experimental | HR+ participants will receive treatment with inavolisib plus abemaciclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Abemaciclib; Drug: Inavolisib (Dose #1); Drug: Giredestrant |
| Inavolisib (Dose #2) + Abemaciclib + Giredestrant | Experimental | HR+ participants will receive treatment with inavolisib plus abemaciclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Abemaciclib; Drug: Inavolisib (Dose #2); Drug: Giredestrant |
| Inavolisib (Dose #2) + Ribociclib (Dose #1) + Giredestrant | Experimental | HR+ participants will receive treatment with inavolisib plus ribociclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Receives: Drug: Ribociclib (Dose #1); Drug: Inavolisib (Dose #2); Drug: Giredestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Baseline until disease progression or loss of clinical benefit (up to approximately 12 years)
Secondary outcomes (6)
Progression Free Survival (PFS)
Measured: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (up to approximately 12 years) as determined by the investigator according to RECIST v1.1
Disease Control Rate (DCR)
Measured: Baseline through end of study (up to approximately 12 years)
Overall Survival (OS)
Measured: Randomization to death from any cause, through the end of study (up to approximately 12 years)
Overall Survival (at specific time-points)
Measured: 12 and 18 months
Duration of Response (DOR)
Measured: Randomization until first occurrence of a documented objective response to the first recorded occurrence of disease progression or death from any cause (whichever occurs first), through end of study (up to approximately 12 years)
Percentage of Participants with Adverse Events
Measured: Baseline to end of study (up to approximately 12 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start30 Mar 2018
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences, Pfizer
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424005
- Sponsor's protocol ID
- CO40115
- Other IDs
- 2017-002038-21, 2023-503629-20-00, 2023, 2017
- Acronym
- Morpheus-panBC
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2018
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)
- ClinicalTrials.gov ID
- NCT03424005
- Acronym / sponsor ID
- Morpheus-panBC / CO40115
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,132 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences, Pfizer
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.
The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study:
Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort).
Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naïve cohort).
Cohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations.
Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).
In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 23
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab + Nab-Paclitaxel | Active comparator | Drug: Atezolizumab, Drug: Nab-Paclitaxel1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus nab-paclitaxel until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed. |
| Atezolizumab + Nab-Paclitaxel + Tocilizumab | Experimental | Drug: Atezolizumab, Drug: Tocilizumab, Drug: Nab-Paclitaxel1L PD-L1-positive participants will receive combination treatment with atezolizumab plus nab-paclitaxel and tocilizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed and participant follow-up is complete. |
| Atezolizumab + Sacituzumab Govitecan | Experimental | Drug: Atezolizumab, Drug: Sacituzumab Govitecan1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus sacituzumab govitecan until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed. |
| Capecitabine | Active comparator | Drug: Capecitabine2L CIT-naïve participants will receive capecitabine until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). Participants who progressed on treatment may have the option of receiving atezolizumab along with chemotherapy (chemo) during stage 2, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete. |
| Atezolizumab + Ipatasertib | Experimental | Drug: Atezolizumab, Drug: Ipatasertib2L CIT-naïve participants will receive doublet combination treatment with atezolizumab plus ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete. |
| Atezolizumab + SGN-LIV1A | Experimental | Drug: Atezolizumab, Drug: SGN-LIV1A2L CIT-naïve participants will receive doublet combination treatment with atezolizumab plus SGNLIV1A until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Patients who experience loss of clinical benefit as determined by the investigator or unacceptable toxicity related to SGN-LIV1A will be given the option of receiving Atezolizumab + chemo during Stage 2, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete. |
| Atezolizumab + Selicrelumab + Bevacizumab | Experimental | Drug: Atezolizumab, Drug: Bevacizumab, Drug: Selicrelumab2L-CIT-naïve participants will receive doublet combination treatment with atezolizumab plus selicrelumab and bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete. |
| Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin) | Experimental | Drug: Atezolizumab, Drug: Chemotherapy (Gemcitabine + Carboplatin or Eribulin)2L CIT-naïve participants enrolled in the active comparator arm who experience disease progression per RECIST v1.1 and 2L CIT-naïve participants enrolled in an experimental arm who experience loss of clinical benefit as determined by the investigator may receive doublet combination treatment with atezolizumab plus chemo (gemcitabine + carboplatin or eribulin) until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed and participant follow-up is complete. |
| Inavolisib (Dose #2) + Abemaciclib + Fulvestrant | Experimental | Drug: Abemaciclib, Drug: Fulvestrant, Drug: Inavolisib (Dose #2)HR+ participants will receive treatment with inavolisib plus abemaciclib plus fulvestrant until unacceptable toxicity or disease progression determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #2) + Ribociclib (Dose #1) + Fulvestrant | Experimental | Drug: Fulvestrant, Drug: Ribociclib (Dose #1), Drug: Inavolisib (Dose #2)HR+ participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #2) + Ribociclib (Dose #1) + Letrozole | Experimental | Drug: Ribociclib (Dose #1), Drug: Letrozole, Drug: Inavolisib (Dose #2)HR+ participants will receive treatment with inavolisib plus ribociclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #2) + Ribociclib (Dose #2) + Fulvestrant | Experimental | Drug: Fulvestrant, Drug: Ribociclib (Dose #2), Drug: Inavolisib (Dose #2)HR+ participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #2) + Ribociclib (Dose #2) + Letrozole | Experimental | Drug: Ribociclib (Dose #2), Drug: Letrozole, Drug: Inavolisib (Dose #2)HR+ participants will receive treatment with inavolisib plus ribociclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #2) + Abemaciclib + Letrozole | Experimental | Drug: Abemaciclib, Drug: Letrozole, Drug: Inavolisib (Dose #2)HR+ participants will receive treatment with inavolisib plus abemaciclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #1) + Trastuzumab Deruxtecan | Experimental | Drug: Inavolisib (Dose #1), Drug: Trastuzumab DeruxtecanHER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Enrollment is closed. |
| Inavolisib (Dose #2) + Trastuzumab Deruxtecan | Experimental | Drug: Trastuzumab Deruxtecan, Drug: Inavolisib (Dose #2)HER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Enrollment is closed. |
| Empagliflozin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib | Experimental | Drug: Fulvestrant, Drug: Inavolisib (Dose #2), Drug: Empagliflozin, Drug: PalbociclibParticipants with locally advanced or metastatic, HR+, HER2- participants will receive empagliflozin plus inavolisib plus fulvestrant with or without palbociclib until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Metformin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib | Experimental | Drug: Fulvestrant, Drug: Inavolisib (Dose #2), Drug: Palbociclib, Drug: MetforminParticipants with locally advanced or metastatic, HR+, HER2- participants will receive metformin plus inavolisib plus fulvestrant with or without palbociclib until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #2) + Atirmociclib (Atirmo) + Fulvestrant | Experimental | Drug: Fulvestrant, Drug: Inavolisib (Dose #2), Drug: AtirmociclibParticipants will receive inavolisib plus atirmociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #1) + Abemaciclib + Letrozole | Experimental | Drug: Abemaciclib, Drug: Inavolisib (Dose #1), Drug: LetrozoleHR+ participants will receive treatment with inavolisib plus abemaciclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #1) + Abemaciclib + Giredestrant | Experimental | Drug: Abemaciclib, Drug: Inavolisib (Dose #1), Drug: GiredestrantHR+ participants will receive treatment with inavolisib plus abemaciclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #2) + Abemaciclib + Giredestrant | Experimental | Drug: Abemaciclib, Drug: Inavolisib (Dose #2), Drug: GiredestrantHR+ participants will receive treatment with inavolisib plus abemaciclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
| Inavolisib (Dose #2) + Ribociclib (Dose #1) + Giredestrant | Experimental | Drug: Ribociclib (Dose #1), Drug: Inavolisib (Dose #2), Drug: GiredestrantHR+ participants will receive treatment with inavolisib plus ribociclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):
- Age >/= 18 years at the time of signing Informed Consent Form
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Able to comply with the study protocol, in the investigator's judgment
- Metastatic or inoperable locally advanced adenocarcinoma of the breast
Key exclusion criteria (20 listed)
- Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds
- Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
- Eligibility only for the control arm
- Exclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: RO0091978Capecitabine will be administered 1250 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day cycle. | Drug | Capecitabine |
| AtezolizumabAlso: RO5541267For Atezolizumab + SGN-LIV1A, Atezolizumab + Sacituzumab Govitecan, or Atezolizumab + Chemo arms: atezolizumab will be administered intravenously (IV), 1200 mg, on Day 1 of each 21-day cycle. For Atezolizumab + Nab-Paclitaxel, Atezolizumab + Selicrelumab + Bevacizumab, Atezolizumab + Ipatasertib, or Atezolizumab + Nab-Paclitaxel + Tocilizumab arms: atezolizumab will be administered IV, 840 mg on Days 1 and 15 of each 28-day cycle. | Drug | Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin), Atezolizumab + Ipatasertib, Atezolizumab + Nab-Paclitaxel, Atezolizumab + Nab-Paclitaxel + Tocilizumab, Atezolizumab + SGN-LIV1A, Atezolizumab + Sacituzumab Govitecan, Atezolizumab + Selicrelumab + Bevacizumab |
| IpatasertibIpatasertib will be administered by mouth 400 mg once a day, on Days 1-21 of each 28-day cycle. | Drug | Atezolizumab + Ipatasertib |
| SGN-LIV1AAlso: RO7235441, Ladiratuzumab vedotinSGN-LIV1A will be administered IV, 2.5 milligrams per kilogram (mg/kg) (maximum calculated dose 250 mg), on Day 1 of each 21-day cycle. | Drug | Atezolizumab + SGN-LIV1A |
| BevacizumabBevacizumab will be administered IV, 10 mg/kg, on Days 1 and 15 of each 28-day cycle. | Drug | Atezolizumab + Selicrelumab + Bevacizumab |
| Chemotherapy (Gemcitabine + Carboplatin or Eribulin)Gemcitabine will be administered by IV, 1000 mg/m^2, along with carboplatin, by IV, on Days 1 and 8 of each 21-day cycle. Or Eribulin will be administered IV, 1.4 mg/m^2 on Days 1 and 8 of each 21-day cycle. | Drug | Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin) |
| SelicrelumabSelicrelumab will be administered by subcutaneous (SC) injection, at a fixed dose of 16 mg on Day 1 of Cycles 1 to 4 and every third cycle thereafter (Cycle = 28 days). | Drug | Atezolizumab + Selicrelumab + Bevacizumab |
| TocilizumabAlso: RO4877533Tocilizumab will be administered IV, 8 mg/kg on Day 1 of each 28-day cycle. | Drug | Atezolizumab + Nab-Paclitaxel + Tocilizumab |
| Nab-PaclitaxelAlso: RO0247506Nab-Paclitaxel will be administered IV, 100 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle. | Drug | Atezolizumab + Nab-Paclitaxel, Atezolizumab + Nab-Paclitaxel + Tocilizumab |
| Sacituzumab GovitecanAlso: RO7445735Sacituzumab govitecan will be administered by IV infusion, 10 mg/kg, on Days 1 and 8 of each 21-day cycle. | Drug | Atezolizumab + Sacituzumab Govitecan |
| AbemaciclibAlso: RO7071651Abemaciclib tablets will be administered at a dose of 150 mg twice daily by mouth on Days 1-28 of each 28-day cycle. | Drug | Inavolisib (Dose #1) + Abemaciclib + Giredestrant, Inavolisib (Dose #1) + Abemaciclib + Letrozole, Inavolisib (Dose #2) + Abemaciclib + Fulvestrant, Inavolisib (Dose #2) + Abemaciclib + Giredestrant, Inavolisib (Dose #2) + Abemaciclib + Letrozole |
| FulvestrantFor Inavolisib + Abemaciclib + Fulvestrant, Inavolisib + Ribociclib (Dose #1) + Fulvestrant, Inavolisib + Ribociclib (Dose #2) + Fulvestrant, or Inavolisib + Atirmociclib + Fulvestrant arms: Fulvestrant 500 mg, administered as an IM injection on Days 1 and 15 of Cycle 1, followed by Day 1 of each 28-day cycle thereafter. For Empa + Inavolisib + Fulvestrant ± Palbociclib, or Metformin + Inavolisib + Fulvestrant ± Palbociclib arms: Fulvestrant 500 mg, administered as an IM injection on Day 1 and as per local prescribing guidelines thereafter. | Drug | Empagliflozin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib, Inavolisib (Dose #2) + Abemaciclib + Fulvestrant, Inavolisib (Dose #2) + Atirmociclib (Atirmo) + Fulvestrant, Inavolisib (Dose #2) + Ribociclib (Dose #1) + Fulvestrant, Inavolisib (Dose #2) + Ribociclib (Dose #2) + Fulvestrant, Metformin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib |
| Ribociclib (Dose #1)Also: RO7072612Ribociclib tablets will be administered by mouth once daily. | Drug | Inavolisib (Dose #2) + Ribociclib (Dose #1) + Fulvestrant, Inavolisib (Dose #2) + Ribociclib (Dose #1) + Giredestrant, Inavolisib (Dose #2) + Ribociclib (Dose #1) + Letrozole |
| Inavolisib (Dose #1)Also: GDC-0077, RO7113755Inavolisib tablets will be administered by mouth once daily. | Drug | Inavolisib (Dose #1) + Abemaciclib + Giredestrant, Inavolisib (Dose #1) + Abemaciclib + Letrozole, Inavolisib (Dose #1) + Trastuzumab Deruxtecan |
| Trastuzumab DeruxtecanTrastuzumab Deruxtecan will be administered IV, 5.4 mg/kg on Day 1 of each 21-day cycle. | Drug | Inavolisib (Dose #1) + Trastuzumab Deruxtecan, Inavolisib (Dose #2) + Trastuzumab Deruxtecan |
| Ribociclib (Dose #2)Also: RO7072612Ribociclib tablets will be administered by mouth once daily. | Drug | Inavolisib (Dose #2) + Ribociclib (Dose #2) + Fulvestrant, Inavolisib (Dose #2) + Ribociclib (Dose #2) + Letrozole |
| LetrozoleLetrozole tablets will be administered at a dose of 2.5 mg once a day by mouth on Days 1-28 of each 28-day cycle. | Drug | Inavolisib (Dose #1) + Abemaciclib + Letrozole, Inavolisib (Dose #2) + Abemaciclib + Letrozole, Inavolisib (Dose #2) + Ribociclib (Dose #1) + Letrozole, Inavolisib (Dose #2) + Ribociclib (Dose #2) + Letrozole |
| Inavolisib (Dose #2)Also: GDC-0077, RO7113755Inavolisib tablets will be administered by mouth OD. | Drug | Empagliflozin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib, Inavolisib (Dose #2) + Abemaciclib + Fulvestrant, Inavolisib (Dose #2) + Abemaciclib + Giredestrant, Inavolisib (Dose #2) + Abemaciclib + Letrozole, Inavolisib (Dose #2) + Atirmociclib (Atirmo) + Fulvestrant, Inavolisib (Dose #2) + Ribociclib (Dose #1) + Fulvestrant, Inavolisib (Dose #2) + Ribociclib (Dose #1) + Giredestrant, Inavolisib (Dose #2) + Ribociclib (Dose #1) + Letrozole, Inavolisib (Dose #2) + Ribociclib (Dose #2) + Fulvestrant, Inavolisib (Dose #2) + Ribociclib (Dose #2) + Letrozole, Inavolisib (Dose #2) + Trastuzumab Deruxtecan, Metformin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib |
| EmpagliflozinEmpagliflozin, administered orally, once daily (QD) | Drug | Empagliflozin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib |
| PalbociclibFor Empagliflozin + Inavolisib + Fulvestrant ± Palbociclib arm: Palbociclib 125 mg administered orally, QD in Cycle 1 followed by 125 mg on Days 1-21 of each cycle. For Metformin + Inavolisib + Fulvestrant ± Palbociclib arm: Palbociclib 125 mg administered orally, QD in Cycle 1, followed by 125 mg on Days 1-21 of each cycle (Cycle=28 days). | Drug | Empagliflozin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib, Metformin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib |
| MetforminMetf 1000 mg administered orally QD. | Drug | Metformin + Inavolisib (Dose #2) + Fulvestrant ± Palbociclib |
| AtirmociclibAtirmociclib administered orally, BID on Days 1-28 for each 28-day cycle. | Drug | Inavolisib (Dose #2) + Atirmociclib (Atirmo) + Fulvestrant |
| GiredestrantGiredestrant 30 mg will be administered by mouth once daily, on Days 1-28 of each 28-day cycle. | Drug | Inavolisib (Dose #1) + Abemaciclib + Giredestrant, Inavolisib (Dose #2) + Abemaciclib + Giredestrant, Inavolisib (Dose #2) + Ribociclib (Dose #1) + Giredestrant |
Primary outcome
Objective Response Rate (ORR)
Time frame: Baseline until disease progression or loss of clinical benefit (up to approximately 12 years)
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (up to approximately 12 years) as determined by the investigator according to RECIST v1.1
Disease Control Rate (DCR)
Time frame: Baseline through end of study (up to approximately 12 years)
Overall Survival (OS)
Time frame: Randomization to death from any cause, through the end of study (up to approximately 12 years)
Overall Survival (at specific time-points)
Time frame: 12 and 18 months
Duration of Response (DOR)
Time frame: Randomization until first occurrence of a documented objective response to the first recorded occurrence of disease progression or death from any cause (whichever occurs first), through end of study (up to approximately 12 years)
Percentage of Participants with Adverse Events
Time frame: Baseline to end of study (up to approximately 12 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: CO40115 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
55 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Capecitabine, Atezolizumab and Ipatasertib in people with Metastatic Breast Cancer, run by Hoffmann-La Roche at 55 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Israel, South Korea, Spain, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: CO40115 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Baseline until disease progression or loss of clinical benefit (up to approximately 12 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.