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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07499999
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exemestane — DRUG
    A steroidal aromatase inhibitor, blinded capsules taken orally, per protocol.
  • Tamoxifen — DRUG
    A selective estrogen receptor modulator, blinded capsules taken orally, per protocol.

Study Details

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)

Key Dates

Start date
Sep 9, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Low-Dose Exemestane
    Participants will be randomized 1:1 with a permuted-block technique and stratified by center and will complete: * Baseline visit with assessments * Predetermined dose of Exemestane 1x on every odd day for 12 months * 3 month in-clinic visit * 6 month in-clinic visit * 9 month in-clinic visit * 12 month end of intervention in-clinic visit * Follow up for 12 months
  • Experimental: Low-Dose Tamoxifen
    Participants will be randomized 1:1 with a permuted-block technique and stratified by center and will complete: * Baseline visit with assessments * Predetermined dose of Tamoxifen 1x on every odd day for 12 months * 3 month in-clinic visit * 6 month in-clinic visit * 9 month in-clinic visit * 12 month end of intervention in-clinic visit * Follow up for 12 months

Primary Outcome Measure

Difference in Overall Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Between the Two Arms at 12 Months [ Time Frame: 12 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Judy Garber, MD, MPH
[email protected]
617-632-2282
Dana Farber Cancer InstituteBostonMassachusetts02215
Judy Garber, MD. MPH
[email protected]
617-632-2282
Judy Garber, MD. MPH
[email protected]
617-632- 2282

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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