Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Conditions

• ER-Positive HER2-Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• AZD9833 — DRUG
  Dosage formulation: AZD9833 tablets will be administered orally
• AZD9833 Placebo — DRUG
  Dosage formulation: AZD9833 placebo tablets will be administrated orally.
• Anastrozole — DRUG
  Dosage formulation: anastrozole tablets will be administered orally.
• Anastrozole placebo — DRUG
  Dosage formulation: anastrozole placebo tablets will be administrated orally.
• Letrozole — DRUG
  Dosage formulation: letrozole tablets will be administered orally.
• Letrozole placebo — DRUG
  Dosage formulation: letrozole placebo tablets will be administered orally.
• Palbociclib — DRUG
  Dosage formulation: palbociclib tablets/capsules will be administered orally
• Abemaciclib — DRUG
  Dosage formulation: abemaciclib tablets will be administered orally
• Luteinizing hormone-releasing hormone (LHRH) agonist — DRUG
  Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.
• Ribociclib — DRUG
  Dosage formulation: ribociclib tablets will be administered orally

Study Details

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

Key Dates

Start date

Jun 30, 2021

Status verified

Apr 2026

Primary completion

Jun 30, 2025

Completion

Sep 1, 2028

Study Design

Enrollment

315 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AZD9833 + palbociclib, abemaciclib or ribociclib
  The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150,100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (PO, once daily) or letrozole placebo (PO, once daily)
• Active Comparator: Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib
  The patients will recieve anastrozole (1 mg, PO, once daily) or letrozole (2.5 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150, 100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily)

Primary Outcome Measure

Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST version 1.1) [ Time Frame: From randomization until the earlier of the progression event or death (approximately 2 years) ]

Locations (65)

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