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4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ

NCT00952731 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-07-21

Study results available
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Summary

This randomized phase II trial is studying 4-hydroxytamoxifen to see how well it works compared with tamoxifen citrate in treating women with newly diagnosed ductal breast carcinoma in situ. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether topical tamoxifen causes less damage to normal tissue than systemic tamoxifen in treating patients with ductal carcinoma in situ.

Conditions

  • Ductal Breast Carcinoma in Situ
  • Estrogen Receptor-positive Breast Cancer

Interventions

DRUG

oral placebo

Oral placebo taken daily for 4-10 weeks.

DRUG

afimoxifene

2mg/breast applied daily in the form of a gel for 4-10 weeks.

DRUG

tamoxifen citrate

20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.

DRUG

placebo gel

Placebo gel applied to breasts daily for 4-10 weeks.

Sponsors & Collaborators

Principal Investigators

  • Seema Khan · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-09-30

Countries

  • United States

Study Locations

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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 NCT00952731 on ClinicalTrials.gov