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Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast

NCT02993159 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-18

Study results available
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Summary

This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.

Conditions

  • Ductal Breast Carcinoma In Situ
  • Estrogen Receptor Positive

Interventions

DRUG

Afimoxifene

Applied to the breast

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo

Given PO

OTHER

Placebo

Applied to the breast

DRUG

Tamoxifen Citrate

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • BHR Pharma, LLC

    collaborator INDUSTRY

  • Northwestern University

    lead OTHER

Principal Investigators

  • Seema Khan, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2021-03-30
Completion
2022-01-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02993159 on ClinicalTrials.gov