A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Conditions

• Early Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Giredestrant — DRUG
  Giredestrant 30 milligrams (mg) will be administered orally once a day (QD) on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).
• Physician's Choice of Endocrine Therapy — DRUG
  The physician's choice of endocrine therapy (PCET) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane. Participants will receive PCET daily on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). Continuing PCET after 5 years is at the discretion of the investigator and per local standard of care. Dose administration of PCET should be performed in accordance with the local prescribing information for the respective product.
• LHRH Agonist — DRUG
  A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Study Details

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Key Dates

Start date

Aug 27, 2021

Status verified

Jun 2026

Primary completion

Aug 8, 2025

Completion

Sep 30, 2033

Study Design

Enrollment

4,170 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Giredestrant
• Active Comparator: Arm B: Physician's Choice of Endocrine Therapy

Primary Outcome Measure

Invasive Disease-Free Survival (IDFS), Excluding Second Primary Non-Breast Cancers [ Time Frame: From randomization to first occurrence of an IDFS event (up to 10 years) ]

Locations (72)

Find similar trials in Daphne, AL

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