A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

June 22, 2021

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2027

Conditions
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
Interventions
DRUG

Giredestrant

30 milligrams (mg) orally once a day (during each 28-day cycle or 21-day cycle, depending on the regimen) until unacceptable toxicity or disease progression

DRUG

Abemaciclib

150 mg orally twice a day (during each 28-day cycle or 21-day cycle, depending on the regimen) until unacceptable toxicity or disease progression

DRUG

Ipatasertib

400 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression

DRUG

Inavolisib

9 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression

DRUG

Ribociclib

600 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression

DRUG

Everolimus

10 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression

DRUG

Samuraciclib

360 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression

DRUG

PH FDC SC

On Day 1 of Cycle 1 (1 cycle is 21 days), pertuzumab and trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) will be administered SC as a fixed dose formulation of 1200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase. On Day 1 of Cycles 2 and beyond, PH FDC SC will be administered SC once every 21 days as a fixed dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase.

DRUG

Palbociclib

125 mg orally once a day on Days 1-21 during each 28-day cycle until unacceptable toxicity or disease progression

DRUG

Atezolizumab

840 mg by intravenous (IV) infusion on Days 1 and 15 each 28-day cycle.

Trial Locations (28)

3000

RECRUITING

Peter Maccallum Cancer Centre, Melbourne

3199

RECRUITING

Peninsula Health-Frankston Hospital, Frankston

5042

RECRUITING

Flinders Medical Centre, Bedford Park

6009

RECRUITING

Linear Clinical Research Limited, Nedlands

10408

RECRUITING

National Cancer Center, Goyang-si

15219

WITHDRAWN

University of Pittsburgh Cancer Institute, Pittsburgh

19107

RECRUITING

Thomas Jefferson University Hospital, Philadelphia

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28050

RECRUITING

Centro Integral Oncológico Clara Campal Ensayos Clínicos START, Madrid

28204

RECRUITING

Levine Cancer Institute, Charlotte

38138

RECRUITING

West Cancer Center, Germantown

46010

RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

90404

RECRUITING

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Santa Monica

91010

WITHDRAWN

City of Hope, Duarte

94143

RECRUITING

University of California, San Francisco (UCSF), San Francisco

94305

RECRUITING

Stanford Cancer Institute (SCI), Stanford

4941492

RECRUITING

Rabin MC, Petah Tikva

5211401

RECRUITING

The Chaim Sheba Medical Center, Ramat Gan

6423906

RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

9112001

RECRUITING

Hadassah Ein Karem Hospital, Jerusalem

02114

RECRUITING

Massachusetts General Hospital, Boston

07728

WITHDRAWN

Regional Cancer Care Associates LLC (RCCA) - Freehold Location, Freehold

07731

WITHDRAWN

Regional Cancer Care Associates LLC ? Howell Division, Howell Township

(0)6351

RECRUITING

Samsung Medical Center, Seoul

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

08035

RECRUITING

Hospital Universitario Vall d Hebron, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY