A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elacestrant — DRUG
  Administered as oral tablets
• Anastrozole — DRUG
  Administered as oral tablets
• Letrozole — DRUG
  Administered as oral tablets
• Exemestane — DRUG
  Administered as oral tablets
• Tamoxifen — DRUG
  Administered as oral tablets

Study Details

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Key Dates

Start date

Sep 27, 2024

Status verified

May 2026

Primary completion

Aug 31, 2029

Completion

Oct 31, 2032

Study Design

Enrollment

4,220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elacestrant
  Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years.
• Experimental: Standard of Care (SoC) Endocrine Therapy
  Participants will receive the SoC endocrine therapy that was used prior to randomization: * AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or * Tamoxifen 20 mg QD

Primary Outcome Measure

Invasive Breast Cancer-Free Survival (IBCFS) [ Time Frame: Up to 5 years ]

Central Contacts

• Stemline Trials
  1-877-332-7961
  [email protected]

Locations (165)

Find similar trials in Daphne, AL

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