Metastatic Breast CancerPhase 3INAVO122NCT05894239
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
A Phase 3 study testing Inavolisib, Phesgo and Taxane-based Chemotherapy in people with Metastatic Breast Cancer, run by Hoffmann-La Roche at 192 sites in 29 countries.
Trial summary
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive… 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?
- Inavolisib, Phesgo and Taxane-based Chemotherapy
- 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
- 230 participants
- Where
- 192 sitesin 29 countries
- Study dates
- 8 Sep 2023to 28 Dec 2032
- Phase
- Phase 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
- Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
- Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status
- Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of >= 6 months
- LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- Adequate hematologic and organ function prior to initiation of study treatment
Who cannot join
- Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
- Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
- History or active inflammatory bowel disease
- Disease progression within 6 months of receiving any HER2-targeted therapy
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Participants with active HBV infection
Show all 12Show fewer
- Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
- Symptomatic active lung disease, including pneumonitis or interstitial lung disease
- Any history of leptomeningeal disease or carcinomatous meningitis
- Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
- Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
- Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
Trial locations and contacts
192 sites in 29 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WO44263 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
192 sites in 29 countries
United States20 sites, 16 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Disney Family Cancer Center
Burbank, California, 91505
- Recruiting
Atrium Health
Charlotte, North Carolina, 28209
- Recruiting
City of Hope
Corona, California, 92882
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
- Recruiting
Renovatio Clinical - El Paso
El Paso, Texas, 79915
- Recruiting
JPS Health Network
Fort Worth, Texas, 76104
- Recruiting
Banner Health MD Anderson AZ
Gilbert, Arizona, 85234
- Withdrawn
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
Medstar Research Institute
Hyattsville, Maryland, 20783
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336-7774
- Withdrawn
Lumi Research
Kingwood, Texas, 77339
- Recruiting
Ellison Medical Institute
Los Angeles, California, 90064
- Withdrawn
Hightower Clinical
Oklahoma City, Oklahoma, 73102
- Withdrawn
Renown Regional Medical Center
Reno, Nevada, 89502
- Recruiting
Swedish Medical Center
Seattle, Washington, 98104-1360
- Recruiting
Renovatio Clinical
The Woodlands, Texas, 77380
- Recruiting
Georgetown Uni Hospital
Washington D.C., District of Columbia, 20007
China16 sites, 7 recruiting
- Recruiting
Affiliated Hospital of Hebei University
Baoding, 071000
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
- Recruiting
The First Hospital of Jilin University
Changchun, 130021
- Completed
Sichuan Provincial Cancer Hospital
Chengdu, 610041
- Active, not recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
- Recruiting
Fujian Cancer Hospital
Fuzhou, 350014
- Active, not recruiting
Zhejiang Cancer Hospital
Hangzhou, 310022
- Active, not recruiting
Harbin Medical University Tumor Hospital
Harbin, 150049
- Recruiting
Shandong Cancer Hospital
Jinan, 250117
- Recruiting
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang, 471003
- Active, not recruiting
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
- Active, not recruiting
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021
- Withdrawn
Shantou Center Hospital
Shantou, 515031
- Recruiting
Tianjin Cancer Hospital
Tianjin, 300000
- Active, not recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
- Active, not recruiting
Hubei Cancer Hospital
Wuhan, 430079
Germany12 sites, 4 recruiting
- Withdrawn
Klinikum St. Marien
Amberg, 92224
- Withdrawn
HELIOS Klinikum Berlin-Buch
Berlin, 13125
- Withdrawn
Marienhospital Bottrop gGmbH
Bottrop, 46236
- Withdrawn
Gynonco Düsseldorf, MVZ Medical Center GmbH
Düsseldorf, 40235
- Withdrawn
Frauenarztpraxis Dr. Apel, Dr. Kolpin
Erfurt, 99084
- Withdrawn
Universitätsklinikum Erlangen
Erlangen, 91054
- Recruiting
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110
- Recruiting
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, 80336
- Recruiting
St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren
Münster, 48145
- Active, not recruiting
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, 66113
- Withdrawn
Gynäkologie Kompetenzzentrum
Stralsund, 18439
- Recruiting
Universitätsfrauenklinik Ulm
Ulm, 89075
Brazil11 sites, 10 recruiting
- Recruiting
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
- Recruiting
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-232
- Recruiting
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070
- Recruiting
Hospital do Câncer de Londrina
Londrina, Paraná, 86015-520
- Active, not recruiting
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
- Recruiting
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
Hospital de Amor Amazônia
Porto Velho, Rondônia, 76834-899
- Recruiting
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000
- Recruiting
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190
- Recruiting
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
- Recruiting
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-001
Italy10 sites
- Active, not recruiting
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Tuscany, 50012
- Active, not recruiting
I.R.S.T Srl IRCCS
Meldola, Emilia-Romagna, 47014
- Active, not recruiting
Ospedale San Raffaele
Milan, Lombardy, 20132
- Active, not recruiting
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133
- Active, not recruiting
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, 20141
- Withdrawn
Ospedale San Gerardo
Monza, Lombardy, 20900
- Active, not recruiting
A.O.U. Maggiore della Carità
Novara, Piedmont, 28100
- Active, not recruiting
Casa di Cura La Maddalena
Palermo, Sicily, 90146
- Active, not recruiting
Ospedale San Giovanni Addolorata
Rome, Lazio, 00185
- Withdrawn
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
Verona, Veneto, 37124
Canada9 sites, 7 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta, T2N 5G2
- Recruiting
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, H4J 1C5
- Recruiting
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec, PO 25223
- Recruiting
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8
- Withdrawn
Allan Blair Cancer Center
Regina, Saskatchewan, S4T 7T1
- Withdrawn
Eastern Health - General Hospital
St. John's, Newfoundland and Labrador, A1B 3V6
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Japan9 sites, 9 recruiting
- Recruiting
Nagoya City University Hospital
Aichi, 467-8602
- Recruiting
Chiba Cancer Center
Chiba, 260-8717
- Recruiting
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
- Recruiting
Sagara Hospital
Kagoshima, 892-0833
- Recruiting
Tokai University Hospital
Kanagawa, 259-1193
- Recruiting
Kyoto University Hospital
Kyoto, 606-8507
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280
- Recruiting
Saitama Medical University International Medical Center
Saitama, 350-1298
- Recruiting
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Turkey (Türkiye)9 sites
- Active, not recruiting
Sakarya Training and Research Hospital
Adapazarı, 54290
- Withdrawn
Gulhane Training and Research Hospital
Ankara, 06010
- Active, not recruiting
Gazi University Medical Faculty
Ankara, 06500
- Active, not recruiting
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, 34147
- Active, not recruiting
Dicle University Faculty of Medicine
Diyarbakır, 21280
- Active, not recruiting
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, 34214
- Active, not recruiting
Izmir Ataturk Training and Research Hospital
Izmir, 35360
- Active, not recruiting
Medical Park Seyhan Hospital
Seyhan, 01140
- Active, not recruiting
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, 06230
Belgium8 sites
- Withdrawn
Institut Jules Bordet
Anderlecht, 1070
- Withdrawn
CHIREC
Auderghem, 1160
- Withdrawn
CHU Brugmann (Victor Horta)
Brussels, 1020
- Withdrawn
Cliniques Universitaires St-Luc
Brussels, 1200
- Withdrawn
GHdC Site Les Viviers
Charleroi, 6000
- Active, not recruiting
CHU HELORA - Hôpital de la Louvière - Site Jolimont
Haine-Saint-Paul, 7100
- Withdrawn
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500
- Withdrawn
Clinique Ste-Elisabeth
Namur, 5000
Poland8 sites
- Active, not recruiting
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, 85-796
- Active, not recruiting
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
- Withdrawn
Szpital Morski im.PCK
Gdynia, 81-519
- Withdrawn
Narodowy Instytut Onkologii Odzia? w Gliwicach
Gliwice, 44-102
- Active, not recruiting
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, 62-500
- Active, not recruiting
Szpital Wojewódzki im. Miko?aja Kopernika
Koszalin, 75-581
- Withdrawn
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
Późna, 61-866
- Active, not recruiting
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
Warsaw, 02-781
Spain8 sites, 7 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, 15006
- Recruiting
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, 08028
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
- Recruiting
Hospital Ramon y Cajal
Madrid, 28034
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
India7 sites, 1 recruiting
- Active, not recruiting
Gujarat Cancer & Research Inst.
Ahmedabad, Gujarat, 380016
- Active, not recruiting
Artemis Hospital
Gurugram, Haryana, 122001
- Withdrawn
Tata Medical Center
Kolkata, West Bengal, 700160
- Withdrawn
Sir H. N. Reliance Foundation Hospital and Research Centre
Mumbai, Maharashtra, 400004
- Recruiting
National Cancer Institute
Nagpur, Maharashtra, 441108
- Withdrawn
Max Super Speciality Hospital
NEW Delhi Delhi, National Capital Territory of Delhi, 110092
- Active, not recruiting
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
Surat, Gujarat, 395007
South Korea7 sites
- Active, not recruiting
National Cancer Center
Goyang-si, 10408
- Active, not recruiting
Seoul National University Hospital
Seoul, 03080
- Active, not recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Active, not recruiting
Asan Medical Center
Seoul, 05505
- Active, not recruiting
Gangnam Severance Hospital
Seoul, 06273
- Active, not recruiting
Samsung Medical Center
Seoul, 06351
- Active, not recruiting
Seoul St Mary's Hospital
Seoul, 06591
Argentina6 sites
- Active, not recruiting
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE
- Active, not recruiting
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE
- Active, not recruiting
Instituto de Oncología de Rosario
Rosario, S2000KZE
- Active, not recruiting
Hospital Provincial del Centenario
Rosario, S2002KDS
- Active, not recruiting
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, J5400DIL
- Withdrawn
Clínica Viedma
Viedma Rio Negro, R8500ACE
Australia6 sites
- Withdrawn
Blacktown Hospital
Blacktown, New South Wales, NSW 2148
- Completed
Monash Health
Clayton, Victoria, 3168
- Withdrawn
Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
- Withdrawn
Gosford Hospital
Gosford, New South Wales, 2250
- Completed
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
- Withdrawn
University of the Sunshine Coast
Sippy Downs, Queensland, 4556
South Africa6 sites
- Completed
Hopelands Cancer Centre
Hilton, 3245
- Active, not recruiting
Charlotte Maxeke Academic Hospital
Johannesburg, 2193
- Withdrawn
Medical Oncology Centre of Rosebank
Johannesburg, 2196
- Withdrawn
Limpopo Cancer Research Institute
Polokwane, 0700
- Active, not recruiting
Steve Biko Academic Hospital
Pretoria, 0002
- Active, not recruiting
Chris Hani Baragwanath Clinical Trial Site
Soweto, 2013
United Kingdom6 sites
- Withdrawn
Belfast City Hospital
Belfast, BT9 7AB
- Active, not recruiting
Blackpool Victoria Hospital
Blackpool, FY3 8NR
- Active, not recruiting
Colchester General Hospital
Colchester, Essex, CO4 5JL
- Active, not recruiting
Mount Vernon Hospital
Northwood, HA6 2RN
- Active, not recruiting
Nottingham City Hospital
Nottingham, NG5 1PB
- Active, not recruiting
Churchill Hospital
Oxford, OX3 7LJ
France5 sites, 5 recruiting
- Recruiting
Institut Sainte Catherine
Avignon, 84082
- Recruiting
Centre Hospitalier de La Cote Basque
Bayonne, 64109
- Recruiting
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
- Recruiting
Centre Georges Francois Leclerc
Dijon, 21000
- Recruiting
Centre Oscar Lambret
Lille, 59020
Mexico5 sites
- Active, not recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
- Active, not recruiting
OncoMed
Mexico City, Mexico CITY (federal District), 03100
- Withdrawn
Centro Oncológico Hematológico Roma
Mexico City, Mexico CITY (federal District), 06700
- Active, not recruiting
CENEIT Oncologicos
Mexico City, 03100
- Withdrawn
Hospital Universitario
Monterrey, Nuevo León, 64460
Tunisia5 sites, 5 recruiting
- Recruiting
Abderrahmen Mami Hospital
Aryanah, 2080
- Recruiting
Taher Maamouri Hospital
Nabeul, 8000
- Recruiting
Habib Bourguiba Hospital
Sfax, 3029
- Recruiting
Farhat Hached Hospital
Sousse, 4031
- Recruiting
Institut Salah Azeiz
Tunis, 1006
Colombia4 sites, 3 recruiting
- Withdrawn
Clinica De La Costa
Barranquilla, 080020
- Recruiting
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., 110131
- Recruiting
Oncomedica S.A.
Montería, 230002
- Recruiting
Sociedad de Oncología y hematología del Cesar Ltda
Valledupar, 200001
Singapore4 sites
- Active, not recruiting
National University Hospital
Singapore, 119228
- Active, not recruiting
National Cancer Centre
Singapore, 169610
- Withdrawn
Icon Cancer Centre Farrer Park
Singapore, 217562
- Withdrawn
Tan Tock Seng Hospital
Singapore, 308433
Taiwan3 sites, 3 recruiting
- Recruiting
National Taiwan Uni Hospital
Taipei, 100
- Recruiting
Tri-Service General Hospital
Taipei
- Recruiting
Chang Gung Memorial Hospital-Linkou
Taoyuan County, 333
Finland2 sites
- Withdrawn
Tampere University Hospital
Tampere, 33520
- Withdrawn
Turku Uni Central Hospital
Turku, 20520
Hong Kong2 sites
- Active, not recruiting
Queen Mary Hospital
Hong Kong
- Active, not recruiting
Tuen Mun Hospital
Hong Kong
Kenya1 site, 1 recruiting
- Recruiting
University of Nairobi - Institute of Tropical and Infectious Diseases
Nairobi
Oman1 site, 1 recruiting
- Recruiting
Sultan Qaboos Comprehensive Cancer Care & Research Center
Muscat
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
- Conditions
- Metastatic Breast Cancer
- Being tested
- Inavolisib, Phesgo, Placebo, Taxane-based Chemotherapy, Optional Endocrine Therapy of Investigator's Choice
- 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
Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.
PhesgoDrug
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
PlaceboDrug
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
Taxane-based ChemotherapyDrug
Also called non-investigational medicinal product (NIMP)
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
Optional Endocrine Therapy of Investigator's ChoiceDrug
Also called NIMP
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI [anastrozole, letrozole, or exemestane]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Induction Therapy: Phesgo plus Taxane-Based Chemotherapy | Other | Participants will be administered the treatments as outlined in the interventions section. Receives: Drug: Phesgo; Drug: Taxane-based Chemotherapy |
| Maintenance Therapy: Inavolisib plus Phesgo | Experimental | Participants will be administered the treatments as outlined in the interventions section. Receives: Drug: Inavolisib; Drug: Phesgo; Drug: Optional Endocrine Therapy of Investigator's Choice |
| Maintenance Therapy: Placebo plus Phesgo | Active comparator | Participants will be administered the treatments as outlined in the interventions section. Receives: Drug: Phesgo; Drug: Placebo; Drug: Optional Endocrine Therapy of Investigator's Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-Assessed Progression-Free Survival (PFS)
Measured: Up to approximately 40 months
Secondary outcomes (8)
Overall Survival (OS)
Measured: Up to approximately 111 months
Investigator-Assessed Objective Response Rate (ORR)
Measured: Up to approximately 111 months
Investigator-Assessed Duration of Response (DOR)
Measured: Up to approximately 111 months
Investigator-Assessed Clinical Benefit Rate (CBR)
Measured: Up to approximately 111 months
Investigator-Assessed PFS2
Measured: Up to approximately 111 months
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)
Assessed through the use of the Functional (Role, Physical) and Global Health Status (GHS)/Quality of Life (QoL) scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
Measured: Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit every 6 months (up to 111 months). Each cycle is 21 days.
Percentage of Participants with Adverse Events
Measured: Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days.
Plasma Concentration of Inavolisib at Specified Timepoints
Measured: Day 1 of Cycles 1 and 4. Each cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start8 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Dec 2032 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (estimated)
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
- NCT05894239
- Sponsor's protocol ID
- WO44263
- Other IDs
- 2022-502046-28-00
- Acronym
- INAVO122
- Status last verified
- Oct 2026
- First submitted
- 24 May 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- 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