Anti-HER2 Therapy + Fulvestrant/Capecitabine in Women With HR+, HER2+, Non-visceral Metastases Stage IV Breast Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

493

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2026

Conditions
HER2-positive Breast Cancer
Interventions
DRUG

Pertuzumab

Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

DRUG

Trastuzumab

Participants will receive trastuzumab (8 mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

DRUG

Fulvestrant

500mg intramuscular injections at day 1, 15, 28 and 4 weeks thereafter

DRUG

Capecitabine

1000mg/m2 orally Bid on day 1 to day 14 every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Trial Locations (2)

310000

Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou

510000

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER