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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

580

Participants

Timeline

Start Date

March 30, 2018

Primary Completion Date

May 3, 2028

Study Completion Date

May 3, 2028

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Capecitabine

Capecitabine will be administered 1250 mg/m\^2 orally twice daily on Days 1-14, of each 21 day cycle.

DRUG

Atezolizumab

"For Atezolizumab (Atezo) + SGN-LIV1A, Atezo + Sacituzumab Govitecan, or Atezo + Chemo arms: atezolizumab will be administered intravenously (IV), 1200 mg, on Day 1 of each 21-day cycle.~For Atezo + Nab-Paclitaxel, Atezo + Selicrelumab + Bevacizumab, Atezo + Ipatasertib, or Atezo + Nab-Paclitaxel + Tocilizumab: atezolizumab will be administered IV, 840 mg on Days 1 and 15, of each 28-day cycle."

DRUG

Ipatasertib

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

DRUG

SGN-LIV1A

SGN-LIV1A will be administered IV, 2.5 mg/kg (maximum calculated dose 250 mg), on Day 1 of each 21 day cycle.

DRUG

Bevacizumab

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

DRUG

Chemotherapy (Gemcitabine + Carboplatin or Eribulin)

"Gemcitabine will be administered by IV, 1000 mg/m\^2, along with carboplatin, by IV, AUC 2, on Days 1 and 8 of each 21 day cycle.~Or~Eribulin will be administered by IV, 1.4 mg/m\^2 on days 1 and 8 of each 21 day cycle."

DRUG

Selicrelumab

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).

DRUG

Tocilizumab

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

DRUG

Nab-Paclitaxel

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

DRUG

Sacituzumab Govitecan

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

DRUG

Abemaciclib

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

DRUG

Fulvestrant

Fulvestrant IM injection at a dose of 500 mg will be administered on Days 1 and 15 of Cycle 1, and then on Day 1 of each cycle thereafter (cycle=28 days).

DRUG

Ribociclib (dose #1)

Ribociclib tablets will be administered by mouth once daily.

DRUG

Inavolisib (dose #2)

Inavolisib tablets will be administered by mouth once daily.

DRUG

Trastuzumab Deruxtecan

Trastuzumab Deruxtecan will be administered at a dose of 5.4 mg/kg by IV infusion on Day 1 of each 21-day cycle.

DRUG

Ribociclib (dose #2)

Ribociclib tablets will be administered by mouth once daily.

DRUG

Letrozole

Letrozole tablets will be administered at a dose of 2.5 mg once a day by mouth on Days 1-28 of each cycle (cycle = 28 days).

DRUG

Inavolisib (dose #1)

Inavolisib tablets will be administered by mouth once daily.

DRUG

Inavolisib

Inavolisib tablets will be administered by mouth once daily.

Trial Locations (42)

3000

RECRUITING

Peter MacCallum Cancer Centre-East Melbourne, Melbourne

6150

RECRUITING

Fiona Stanley Hospital - Medical Oncology, Murdoch

10016

WITHDRAWN

NYU Langone Medical Center, New York

15213

WITHDRAWN

University of Pittsburgh Medical Center, Pittsburgh

19107

WITHDRAWN

Thomas Jefferson University Hospital, Philadelphia

28034

RECRUITING

Hospital Universitario Ramon y Cajal, Madrid

28050

RECRUITING

Centro Integral Oncológico Clara Campal Ensayos Clínicos START, Madrid

31059

RECRUITING

Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse

33612

COMPLETED

H. Lee Moffitt Cancer Center and Research Inst., Tampa

34298

WITHDRAWN

Institut régional du Cancer Montpellier, Montpellier

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

38138

RECRUITING

The West Clinic, Germantown

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

45147

RECRUITING

Universitätsklinikum Essen, Essen

69008

ACTIVE_NOT_RECRUITING

Centre Léon Bérard, Lyon

69710

RECRUITING

Assuta Medical Centers, Tel Aviv

80501

COMPLETED

Rocky Mountain Cancer Center - Longmont, Longmont

91010

COMPLETED

City of Hope, Duarte

91054

RECRUITING

Universitätsklinikum Erlangen, Erlangen

91120

RECRUITING

Hadassah University Medical Center, Jerusalem

92093

COMPLETED

University of California San Diego Medical Center, La Jolla

94305

WITHDRAWN

Stanford Cancer Institute, Stanford

94805

RECRUITING

Gustave Roussy, Villejuif

704302

RECRUITING

National Cheng Kung University Hospital, Tainan City

3109601

RECRUITING

Rambam Medical Center, Haifa

4941492

RECRUITING

Rabin MC, Petah Tikva

5262100

RECRUITING

Sheba Medical Center, Ramat Gan

6423906

RECRUITING

Tel-Aviv Sourasky Medical Center, Tel Aviv

9103102

RECRUITING

Shaare Zedek Medical Center, Jerusalem

07601

WITHDRAWN

Hackensack Univ Medical Center, Hackensack

07731

WITHDRAWN

Regional Cancer Care Associates, LLC, Howell Township

08901

WITHDRAWN

Rutgers Cancer Institute of New Jersey, New Brunswick

75075-7787

WITHDRAWN

Texas Oncology-Plano East, Plano

410-769

RECRUITING

National Cancer Center Clinical Trials Center / Center for Breast Cancer, Goyang-si

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

05505

RECRUITING

University of Ulsan College of Medicine - Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

08003

RECRUITING

Hospital del Mar, Barcelona

08035

RECRUITING

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

G12 0YN

COMPLETED

Beatson West of Scotland Cancer Centre, Glasgow

EC1A 7BE

ACTIVE_NOT_RECRUITING

Barts Health NHS Trust - St Bartholomew's Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY