Completed PHASE2 INTERVENTIONAL 2-arm NCT00952731

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

Pre-surgical Phase IIb Trial of Transdermal 4-Hydroxytamoxifen vs. Oral Tamoxifen in Women With Ductal Carcinoma in Situ of the Breast

Sponsor: National Cancer Institute (NCI)

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

Interventions afimoxifene oral placebo placebo gel tamoxifen citrate

Updated 7 times since 2017 Last updated: Jul 18, 2015 Started: Dec 31, 2009 Primary completion: Sep 30, 2011

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Ductal Breast Carcinoma in Situ and Estrogen Receptor-positive Breast Cancer and is currently completed. National Cancer Institute (NCI) leads this study, which shows 7 recorded versions since 2009 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Dec 2021 — Jul 2024 [monthly]

Completed PHASE2
Jan 2021 — Dec 2021 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Dec 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)
Northwestern University

Data source: Northwestern University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Chicago, United States