Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial

Conditions

• Breast Atypical Ductal Hyperplasia
• Breast Atypical Lobular Hyperplasia
• Breast Carcinoma
• Breast Ductal Carcinoma In Situ
• Breast Lobular Carcinoma In Situ
• Estrogen Receptor-Positive Breast Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Mammography — PROCEDURE
  Undergo mammography
• Questionnaire Administration — OTHER
  Ancillary studies
• Tamoxifen — DRUG
  Given PO

Study Details

This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.

Key Dates

Start date

Sep 27, 2024

Status verified

Mar 2026

Primary completion

Mar 31, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

200 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Prevention (tamoxifen)
  Participants receive tamoxifen 5mg PO QD for 6 months. Participants with aDAR \>= 10% on mammogram at 6 months continue receiving tamoxifen 5mg PO QD for 12 months. Participants with aDAR \< 10% at 6 months are escalated to receive tamoxifen 10mg PO QD for 6 months. Participants with aDAR \>= 10% after 6 months of tamoxifen 10mg continue receiving tamoxifen 10 mg PO QD for 6 months. Participants with aDAR \< 10% after 6 months of tamoxifen 10mg are given the option of continuing tamoxifen 10mg or escalating to receive tamoxifen 20mg PO QD for 6 months. Participants undergo mammography and collection of blood samples at screening and on study. Participants may optionally undergo biopsy at screening and on study.

Primary Outcome Measure

Proportion of women who have a response at any time point [ Time Frame: At 6, 12, and 18 months ]

Locations (11)

Find similar trials in Tucson, AZ

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