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Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer Risk

NCT04570956 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-01-23

No results posted yet for this study

Summary

The investigators plan to prospectively study breast tissue changes after a short course of Tamoxifen (Tam).

Conditions

  • Breast Atypical Hyperplasia
  • Breast Lobular Carcinoma in Situ
  • Breast Atypical Lobular Hyperplasia
  • Breast Carcinoma

Interventions

DRUG

Tamoxifen

Oral Tamoxifen 10 mg/day

DRUG

Topical 4-OHT( 4-hydroxytamoxifen)gel 4 mg/each breast/day

Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day

DRUG

Placebo

placebo pill or placebo gel

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Amy Degnim, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2024-10-15
Completion
2024-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT04570956 on ClinicalTrials.gov