Breast CancerPhase 2/3INAVO120NCT04191499
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
A Phase 2/3 study testing Inavolisib, Palbociclib and Fulvestrant in people with Breast Cancer, run by Hoffmann-La Roche at 135 sites in 28 countries.
Trial summary
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Inavolisib, Palbociclib and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 135 sitesin 28 countries
- Study dates
- 29 Jan 2020to 15 Nov 2027
- Phase
- Phase 2/3
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
- Confirmed diagnosis of HR+/HER2- breast cancer
- Metastatic or locally advanced disease not amenable to curative therapy
- Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- Consent to provide fresh or archival tumor tissue specimen
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- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of > 6 months
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Who cannot join
- Metaplastic breast cancer
- Any history of leptomeningeal disease or carcinomatous meningitis
- Any prior systemic therapy for metastatic breast cancer
- Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
- Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
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- Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
- Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
- Symptomatic active lung disease, or requiring daily supplemental oxygen
- History of inflammatory bowel disease or active bowel inflammation
- Anti-cancer therapy within 2 weeks before study entry
- Investigational drug(s) within 4 weeks before randomization
- Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
- Chronic corticosteroid therapy or immunosuppressants
- Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 2 weeks after the final dose of study treatment
- Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1
Trial locations and contacts
135 sites in 28 countries.
135 sites in 28 countries
Spain15 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Insituto Catalán de Oncologia (ICO)
Barcelona, 08907
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
Jaén, 23007
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Clinica Universidad de Navarra-Madrid
Madrid, 28027
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro
Madrid, 28222
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Universitario Virgen Macarena
Seville, 41009
Instituto Valenciano Oncologia
Valencia, 46009
Hospital Clinico Universitario de Valencia
Valencia, 46010
China13 sites
Beijing Cancer Hospital
Beijing, 100142
The First Hospital of Jilin University
Changchun, 130021
The First Affiliated Hospital, Chongqing Medical University
Chongqing, 400016
Fujian Medical University Union Hospital
Fujian, 350001
Sun Yet-sen University Cancer Center
Guangzhou, 510060
Zhejiang Cancer Hospital
Hangzhou, 310022
Harbin Medical University Cancer Hospital
Harbin, 150081
Fudan University Shanghai Cancer Center
Shanghai, 201315
Hebei Medical University Fourth Hospital
Shijiazhuang, 050035
Tianjin Cancer Hospital
Tianjin, 300060
Hubei Cancer Hospital
Wuhan, 430079
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061
Henan Cancer Hospital
Zhengzhou, 450008
South Korea11 sites
Pusan National University Hospital
Busan, 49241
Kyungpook National University Medical Center
Daegu, 41404
National Cancer Center
Gyeonggi-do, 10408
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
Ewha Womans University Mokdong Hospital
Seoul, 07985
Samsung Medical Center
Seoul, 6351
United States10 sites
Texas Oncology - Central South
Austin, Texas, 78731
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Massachusetts General Hospital.
Boston, Massachusetts, 02114
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee, 37403
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Northwest Medical Specialties
Tacoma, Washington, 98405
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
Russia8 sites
Moscow Clinical Scientific Center
Moscow, Moscow Oblast, 111123
Blokhin Cancer Research Center
Moscow, Moscow Oblast, 115552
MEDSI Clinical Hospital on Pyatnitsky Highway
Moscow, Moscow Oblast, 143422
LLC Medscan
Moskva, Moscow Oblast, 119421
Medical Clinic "AB Medical group"
Saint Petersburg, Sankt-Peterburg, 197082
Volgograd Regional Clinical Oncology Dispensary
Volgograd, 400138
Regional Clinical Oncology Hospital
Yaroslavl, 150040
Clinical Hospital Lapino (LLC Haven)
Yudino, Moscow Oblast, 143081
Australia6 sites
Western Health
Fitzroy, Victoria, 3065
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
Macquarie University Hospital
Macquarie Park, New South Wales, 2109
Mater Adult Hospital
South Brisbane, Queensland, 4101
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Germany6 sites
Ambulantes Tumorzentrum Spandau
Berlin, 13581
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, 45136
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120
Universitätsklinikum Mannheim
Mannheim, 68167
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Trier, 54290
Universitätsfrauenklinik Ulm
Ulm, 89075
Ukraine6 sites
City Clinical Hospital #4
Dnipropetrovsk, 49102
Municipal Institution SubCarpathian Clinical Oncological Centre
Ivano-Frankivsk, KIEV Governorate, 76018
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
Kharkiv, Kharkiv Governorate, 61018
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
Kryvyi Rih, 50048
Kyiv City Clinical Oncological Center
Kyiv, 03115
Uzhhorod Central City Clinical Hospital
Uzhhorod, KIEV Governorate, 88000
Canada5 sites
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta, T2N 5G2
London Regional Cancer Program, London Health Sciences Centre, Baines Centre
London, Ontario, N6A 4L6
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8
Princess Margaret Cancer Center
Toronto, Ontario, M5G 1Z5
France5 sites
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
Clermont-Ferrand, 63003
Centre Georges Francois Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Hopital Prive Jean Mermoz
Lyon, 69373
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, 31059
Italy5 sites
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Tuscany, 50012
Az. Osp. Spedali Civili
Brescia, Lombardy, 25123
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128
A.O. Universitaria Di Parma
Parma, Emilia-Romagna, 43100
Taiwan5 sites
Kaohsiung Medical Uni Chung-Ho Hospital
Kaohsiung City, 807
Veterans General Hospital
Taipei, 00112
National Taiwan Uni Hospital
Taipei, 100
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112
Tri-Service General Hospital, Division of General Surgery
Taipei, 114
Turkey (Türkiye)5 sites
Adana Baskent University Hospital
Adana, 01120
Gulhane Training and Research Hospital
Ankara, 06010
Ege University Medical Faculty
Bornova, ?zm?r, 35100
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, 34098
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, 34384
Greece4 sites
Anticancer Hospital Ag. Savas
Athens, 115 22
Univ General Hosp Heraklion
Heraklion, 711 10
Euromedical General Clinic of Thessaloniki
Thessaloniki, 546 45
European Interbalkan Medical Center
Thessaloniki, 570 01
Thailand4 sites
Ramathibodi Hospital
Bangkok, 10400
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Chulabhorn Hospital
Lak Si, 10210
Songklanagarind Hospital
Songkhla, 90110
United Kingdom4 sites
Royal Marsden Hospital - Fulham
London, SW3 6JJ
Mount Vernon Hospital
Northwood, HA6 2RN
Churchill Hospital
Oxford, OX3 7LJ
Derriford Hospital
Plymouth, PL6 8DH
Argentina3 sites
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE
Hosp Provincial D. Centenarios
Rosario, S2002KDS
Hungary3 sites
Orszagos Onkologiai Intezet
Budapest, 1122
Uzsoki Utcai Korhaz
Budapest, 1145
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5004
Malaysia3 sites
Hospital Sultan Ismail
Johor Bahru, Johor, 81100
National Cancer Institute IKN
Putrajaya, Federal Territory of Putrajaya, 62250
Sarawak General Hospital
Sarawak, Sarawak, 93586
Poland3 sites
Narodowy Instytut Onkologii Odzia? w Gliwicach
Gliwice, 44-102
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, 625000
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warsaw, 02-781
Georgia2 sites
Israel-Georgian Medical Research Clinic Healthycore
Tbilisi, 0112
Tbilisi Oncology Dispensary
Tbilisi, 0159
Portugal2 sites
Centro Clinico Champalimaud
Lisbon, 1400-038
IPO do Porto
Porto, 4200-072
Singapore2 sites
National University Hospital
Singapore, 119228
National Cancer Centre
Singapore, 168583
Brazil1 site
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
- Conditions
- Breast Cancer
- Being tested
- Inavolisib, Placebo, Palbociclib, Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InavolisibDrug
Also called GDC-0077
Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.
PlaceboDrug
Participants will receive oral placebo on Days 1-28 of each 28-day cycle.
PalbociclibDrug
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
FulvestrantDrug
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Inavolisib + Palbociclib + Fulvestrant | Experimental | Participants will receive inavolisib, palbociclib, and fulvestrant. Receives: Drug: Inavolisib; Drug: Palbociclib; Drug: Fulvestrant |
| Placebo + Palbociclib + Fulvestrant | Placebo comparator | Participants will receive placebo, palbociclib, and fulvestrant. Participants randomized to the placebo arm who are still deriving benefit from the study treatment will be given an optional opportunity to crossover to the inavolisib arm. Receives: Drug: Placebo; Drug: Palbociclib; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology.
Measured: Up to 3.7 years
Secondary outcomes (13)
Percentage of Participants With Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a complete response (CR) and/or partial response (PR) on at least two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline.
Measured: Up to approximately 6 years
Percentage of Participants With Best Overall Response Rate (BOR)
BOR is defined as the percentage of participants with a CR or PR, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline.
Measured: Up to approximately 6 years
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of a CR or PR to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). CR is defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Measured: Up to approximately 6 years
Percentage of Participants With Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a CR, PR, and/or stable disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1. CR= disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. PD=at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum in the study.
Measured: Up to approximately 6 years
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: Up to approximately 6 years
Time to Deterioration (TTD) in Pain
TTD in pain is defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline on the "worst pain" item from the Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a self-administered questionnaire in which the participant was asked to rate severity on a 10-point scale where 0 represents 'No pain/No interference' and 10 represents 'Pain/Interference as bad as you can imagine'. A ≥2-point change is defined as clinically meaningful difference.
Measured: From randomization to first documentation of a ≥ 2-point increase (Up to approximately 6 years)
TTD in Physical Function (PF)
TTD in physical function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) PF scale (items 1-5). A ≥10-point change is defined as a clinically meaningful difference. EORTC QLQ-C30 is a cancer-specific health-related quality-of life (QoL) questionnaire with 30 questions. For the PF scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) is scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning.
Measured: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]
TTD in Role Function (RF)
TTD in Role Function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-C30 RF scale (items 6 and 7). A ≥10-point change is defined as clinically meaningful difference. EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning.
Measured: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]
TTD in Global Health Status (GHS)
TTD in (GHS)/health-related quality of life (HRQoL) is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-30 GHS/HRQoL scale. A ≥10-point change is defined as clinically meaningful difference. EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to the questions regarding Global Health Status (Q29: GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome.
Measured: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]
Number of Participants With Adverse Events (AEs)
An AE is an untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
Measured: Up to approximately 6 years
Plasma Concentration of Inavolisib
Measured: Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
Plasma Concentration of Palbociclib
Measured: Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
Plasma Concentration of Fulvestrant
Measured: Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start29 Jan 2020
- Primary completion29 Sep 2023
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191499
- Sponsor's protocol ID
- WO41554
- Other IDs
- 2019-002455-42, 2023-505812-39-00, 2023, 2019
- Acronym
- INAVO120
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2019
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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
Publications
Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, Loi S, Thanopoulou E, Shankar N, Jin Y, Stout TJ, Clark TD, Song C, Juric D, Turner NC. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Jul 10;393(2):151-161. doi: 10.1056/NEJMoa2501796. Epub 2025 May 31.
PubMed 40454641Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625.
PubMed 39476340