A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

NCT03424005 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CO401152017-002038-212023-503629-20-00
• Study Type: interventional
• Target: 792
• Locations: 9 countries
• Sites: 45

Brief 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. During Stage 1, six 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, and 6 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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Baseline until disease progression or loss of clinical benefit (up to approximately 10 years)

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  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 10 years) as determined by the investigator according to RECIST v1.1

• Disease Control Rate (DCR)

  Baseline through end of study (up to approximately 10 years)

• Overall Survival (OS)

  Randomization to death from any cause, through the end of study (up to approximately 10 years)

• Overall Survival (at specific time-points)

  12 and 18 months

• Duration of Response (DOR)

  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 10 years)

Study Arms (19)

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.

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.

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.

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.

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.

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.

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.

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.

Drug: Atezolizumab; Drug: Chemotherapy (Gemcitabine + Carboplatin or Eribulin)

Inavolisib + 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.

Drug: Abemaciclib; Drug: Fulvestrant; Drug: Inavolisib

Inavolisib + 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.

Drug: Fulvestrant; Drug: Ribociclib (Dose #1); Drug: Inavolisib

Inavolisib + 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.

Drug: Ribociclib (Dose #1); Drug: Letrozole; Drug: Inavolisib

Inavolisib + 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.

Drug: Fulvestrant; Drug: Ribociclib (Dose #2); Drug: Inavolisib

Inavolisib + 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.

Drug: Ribociclib (Dose #2); Drug: Letrozole; Drug: Inavolisib

Inavolisib + 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.

Drug: Abemaciclib; Drug: Letrozole; Drug: Inavolisib

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.

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.

Drug: Trastuzumab Deruxtecan; Drug: Inavolisib (Dose #2)

Empagliflozin (Empa) + Inavolisib (Inavo) + Fulvestrant (Fulv) ± Palbociclib (Palbo)

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.

Drug: Fulvestrant; Drug: Inavolisib; Drug: Empagliflozin; Drug: Palbociclib

Metformin (Metf) + Inavolisib + 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.

Drug: Fulvestrant; Drug: Inavolisib; Drug: Palbociclib; Drug: Metformin

Inavolisib + 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.

Drug: Fulvestrant; Drug: Inavolisib; Drug: Atirmociclib

Interventions

Atezolizumab DRUG

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.

Also known as: RO5541267

Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin); Atezolizumab + Ipatasertib; Atezolizumab + Nab-Paclitaxel; Atezolizumab + Nab-Paclitaxel + Tocilizumab; Atezolizumab + SGN-LIV1A; Atezolizumab + Sacituzumab Govitecan; Atezolizumab + Selicrelumab + Bevacizumab

Ipatasertib DRUG

Ipatasertib will be administered by mouth 400 mg once a day, on Days 1-21 of each 28-day cycle.

Atezolizumab + Ipatasertib

SGN-LIV1A DRUG

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.

Also known as: RO7235441, Ladiratuzumab vedotin

Atezolizumab + SGN-LIV1A

Capecitabine DRUG

Capecitabine will be administered 1250 milligrams per square meter (mg/m\^2) orally twice daily on Days 1-14 of each 21-day cycle.

Also known as: RO0091978

Capecitabine

Bevacizumab DRUG

Bevacizumab will be administered IV, 10 mg/kg, on Days 1 and 15 of each 28-day cycle.

Atezolizumab + Selicrelumab + Bevacizumab

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.

Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin)

Selicrelumab DRUG

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).

Atezolizumab + Selicrelumab + Bevacizumab

Tocilizumab DRUG

Tocilizumab will be administered IV, 8 mg/kg on Day 1 of each 28-day cycle.

Also known as: RO4877533

Atezolizumab + Nab-Paclitaxel + Tocilizumab

Nab-Paclitaxel DRUG

Nab-Paclitaxel will be administered IV, 100 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.

Also known as: RO0247506

Atezolizumab + Nab-Paclitaxel; Atezolizumab + Nab-Paclitaxel + Tocilizumab

Sacituzumab Govitecan DRUG

Sacituzumab govitecan will be administered by IV infusion, 10 mg/kg, on Days 1 and 8 of each 21-day cycle.

Also known as: RO7445735

Atezolizumab + Sacituzumab Govitecan

Abemaciclib DRUG

Abemaciclib tablets will be administered at a dose of 150 mg twice daily by mouth on Days 1-28 of each 28-day cycle.

Also known as: RO7071651

Inavolisib + Abemaciclib + Fulvestrant; Inavolisib + Abemaciclib + Letrozole

Fulvestrant DRUG

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.

Empagliflozin (Empa) + Inavolisib (Inavo) + Fulvestrant (Fulv) ± Palbociclib (Palbo); Inavolisib + Abemaciclib + Fulvestrant; Inavolisib + Atirmociclib (Atirmo) + Fulvestrant; Inavolisib + Ribociclib (Dose #1) + Fulvestrant; Inavolisib + Ribociclib (Dose #2) + Fulvestrant; Metformin (Metf) + Inavolisib + Fulvestrant ± Palbociclib

Ribociclib (Dose #1) DRUG

Ribociclib tablets will be administered by mouth once daily.

Also known as: RO7072612

Inavolisib + Ribociclib (Dose #1) + Fulvestrant; Inavolisib + Ribociclib (Dose #1) + Letrozole

Inavolisib (Dose #1) DRUG

Inavolisib tablets will be administered by mouth once daily.

Also known as: GDC-0077, RO7113755

Inavolisib (Dose #1) + Trastuzumab Deruxtecan

Trastuzumab Deruxtecan DRUG

Trastuzumab Deruxtecan will be administered IV, 5.4 mg/kg on Day 1 of each 21-day cycle.

Inavolisib (Dose #1) + Trastuzumab Deruxtecan; Inavolisib (Dose #2) + Trastuzumab Deruxtecan

Ribociclib (Dose #2) DRUG

Ribociclib tablets will be administered by mouth once daily.

Also known as: RO7072612

Inavolisib + Ribociclib (Dose #2) + Fulvestrant; Inavolisib + Ribociclib (Dose #2) + Letrozole

Letrozole DRUG

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 + Abemaciclib + Letrozole; Inavolisib + Ribociclib (Dose #1) + Letrozole; Inavolisib + Ribociclib (Dose #2) + Letrozole

Inavolisib (Dose #2) DRUG

Inavolisib tablets will be administered by mouth once daily.

Also known as: GDC-0077, RO7113755

Inavolisib (Dose #2) + Trastuzumab Deruxtecan

Inavolisib DRUG

Inavolisib tablets will be administered by mouth OD.

Also known as: GDC-0077, RO7113755

Empagliflozin (Empa) + Inavolisib (Inavo) + Fulvestrant (Fulv) ± Palbociclib (Palbo); Inavolisib + Abemaciclib + Fulvestrant; Inavolisib + Abemaciclib + Letrozole; Inavolisib + Atirmociclib (Atirmo) + Fulvestrant; Inavolisib + Ribociclib (Dose #1) + Fulvestrant; Inavolisib + Ribociclib (Dose #1) + Letrozole; Inavolisib + Ribociclib (Dose #2) + Fulvestrant; Inavolisib + Ribociclib (Dose #2) + Letrozole; Metformin (Metf) + Inavolisib + Fulvestrant ± Palbociclib

Empagliflozin DRUG

Empagliflozin, administered orally, once daily (QD)

Empagliflozin (Empa) + Inavolisib (Inavo) + Fulvestrant (Fulv) ± Palbociclib (Palbo)

Palbociclib DRUG

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).

Empagliflozin (Empa) + Inavolisib (Inavo) + Fulvestrant (Fulv) ± Palbociclib (Palbo); Metformin (Metf) + Inavolisib + Fulvestrant ± Palbociclib

Metformin DRUG

Metf 1000 mg administered orally QD.

Metformin (Metf) + Inavolisib + Fulvestrant ± Palbociclib

Atirmociclib DRUG

Atirmociclib administered orally, BID on Days 1-28 for each 28-day cycle.

Inavolisib + Atirmociclib (Atirmo) + Fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 breast cancer
• Measurable disease (at least one target lesion) according to RECIST v1.1
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Gilead Sciences: collaborator
• Pfizer: collaborator

Study Sites (45)

City of Hope

Duarte, California, 91010, United States

COMPLETED

University of California San Diego Medical Center

La Jolla, California, 92093, United States

COMPLETED

Stanford Cancer Institute

Stanford, California, 94305, United States

WITHDRAWN

Rocky Mountain Cancer Center - Longmont

Longmont, Colorado, 80501, United States

COMPLETED

H. Lee Moffitt Cancer Center and Research Inst.

Tampa, Florida, 33612, United States

COMPLETED

Hackensack Univ Medical Center

Hackensack, New Jersey, 07601, United States

WITHDRAWN

Regional Cancer Care Associates, LLC

Howell Township, New Jersey, 07731, United States

WITHDRAWN

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

WITHDRAWN

NYU Langone Medical Center

New York, New York, 10016, United States

WITHDRAWN

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

WITHDRAWN

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

WITHDRAWN

Tennessee Oncology - Chattanooga Oncology & Hematology Associates

Chattanooga, Tennessee, 37404, United States

RECRUITING

The West Clinic

Germantown, Tennessee, 38138, United States

RECRUITING

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

Texas Oncology-Plano East

Plano, Texas, 75075-7787, United States

WITHDRAWN

Peter MacCallum Cancer Centre-East Melbourne

Melbourne, Victoria, 3000, Australia

RECRUITING

Fiona Stanley Hospital - Medical Oncology

Murdoch, Western Australia, 6150, Australia

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

ACTIVE NOT RECRUITING

Institut régional du Cancer Montpellier

Montpellier, 34298, France

WITHDRAWN

Institut Universitaire du Cancer de Toulouse-Oncopole

Toulouse, 31059, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

RECRUITING

Rambam Medical Center

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

Hadassah University Medical Center

Jerusalem, 91120, Israel

RECRUITING

Rabin MC

Petah Tikva, 55900, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, 5262100, Israel

RECRUITING

Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Assuta Medical Centers

Tel Aviv, 69710, Israel

RECRUITING

National Cancer Center Clinical Trials Center / Center for Breast Cancer

Goyang-si, 410-769, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

University of Ulsan College of Medicine - Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41009, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Centro Integral Oncológico Clara Campal Ensayos Clínicos START

Madrid, 28050, Spain

RECRUITING

National Cheng Kung University Hospital

Tainan, 704302, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

COMPLETED

Barts Health NHS Trust - St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

COMPLETED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; atezolizumab; ipatasertib; SGN-LIV1A; Bevacizumab; Drug Therapy; Gemcitabine; Carboplatin; eribulin; selicrelumab; tocilizumab; 130-nm albumin-bound paclitaxel; sacituzumab govitecan; abemaciclib; Fulvestrant; ribociclib; inavolisib; trastuzumab deruxtecan; Letrozole; empagliflozin; palbociclib; Metformin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics; Coordination Complexes; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Triazoles; Azoles; Biguanides; Guanidines; Amidines

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CO40115 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 6, 2018
• Study Start: March 30, 2018
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (2); IL (7); TW (2); KR (5); DE (2); ES (5); US (16); FR (4); AU (2)