A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

Conditions

• Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Giredestrant — DRUG
  Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
• Giredestrant-matched Placebo — DRUG
  Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
• Letrozole — DRUG
  Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
• Letrozole-matched Placebo — DRUG
  Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
• Palbociclib — DRUG
  Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.
• LHRH Agonist — DRUG
  Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Study Details

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

Key Dates

Start date

Oct 9, 2020

Status verified

May 2026

Primary completion

Jan 30, 2026

Completion

Mar 25, 2028

Study Design

Enrollment

992 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Giredestrant + Letrozole-matched Placebo + Palbociclib
• Active Comparator: Letrozole + Giredestrant-matched Placebo + Palbociclib

Primary Outcome Measure

Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months) ]

Locations (37)

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