Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

June 11, 2020

Primary Completion Date

April 30, 2025

Study Completion Date

June 30, 2028

Conditions
Cancer Metastatic
Interventions
DRUG

Paclitaxel injection

Paclitaxel is administrated at the dose of 80 mg/m² as a 1-hour intravenous infusion every week (i.e., D1, D8 and D15) of a 3-week cycle

DRUG

Capecitabine tablets

Capecitabine is given orally at a dose of 2000 to 2500 mg/m² daily for 14 days followed by a 7-day rest period every 3 weeks

DRUG

Letrozole 2.5mg

Letrozole is administered orally at 2.5 mg/day continuous for patients nonsteroidal aromatase inhibitor naïve or relapsing \>1 year after the end of adjuvant endocrine therapy.

DRUG

Anastrozole 1mg

Anastrozole is administered orally at 1 mg/day continous for patients nonsteroidal aromatase inhibitor (NSAI) naïve or relapsing \>1 year after the end of adjuvant endocrine therapy.

DRUG

Fulvestrant Prefilled Syringe

Fulvestrant is administered at the dose of 500 mg intramuscular on D1-D15-D29 (as a loading dose), and then 500 mg every 28 days (as a maintenance dose) for patients relapsing on adjuvant or less than one year after completion of adjuvant NSAI.

DRUG

Abemaciclib

Oral 150 mg BID continuous

Trial Locations (2)

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

Unknown

Centre Eugène Marquis, Rennes

All Listed Sponsors
lead

UNICANCER

OTHER

NCT04158362 - Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer | Biotech Hunter | Biotech Hunter