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Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer

NCT07499999 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-03-30

No results posted yet for this study

Summary

The goal of this research study is to evaluate the efficacy and safety of low-dose exemestane versus low-dose tamoxifen in post-menopausal women at high risk for breast cancer.

The names of the study drugs involved in this study are:

* Exemestane (a type of steroidal aromatase inhibitor)
* Tamoxifen (a type of selective estrogen receptor modulator)

Conditions

  • Breast Cancer
  • Ductal Carcinoma
  • Estrogen-receptor-positive Breast Cancer
  • Atypical Lobular Hyperplasia
  • BRCA2 Mutation
  • CHEK2 Gene Mutation
  • Ataxia Telangiectasia Mutated Gene Mutation

Interventions

DRUG

Exemestane

A steroidal aromatase inhibitor, blinded capsules taken orally, per protocol.

DRUG

Tamoxifen

A selective estrogen receptor modulator, blinded capsules taken orally, per protocol.

Sponsors & Collaborators

Principal Investigators

  • Judy Garber, MD. MPH · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-09
Primary Completion
2027-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499999 on ClinicalTrials.gov