CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
acolbifene hydrochloridedrug
Likely dose
Acolbifene hydrochloride — oral dose not specified in published recordAI-extracted
Key inclusion· 7
  • ✓Gail risk ≥1.7% and/or relative risk ≥3 times that for 5-year age group
  • ✓Premenopausal with regular menstrual cycles (21-35 days)
  • ✓At least one high-risk feature: BRCA1/2 mutation, prior atypical ductal hyperplasia/DCIS/LCIS, atypical hyperplasia on prior RPFNA, or family history of breast cancer (≥4 relatives or ≥2 diagnosed ≤50 years or breast and ovarian cancer in same relative)
  • ✓Hyperplasia with or without atypia (Masood score ≥14) with ≥500 cells AND Ki-67 positivity ≥2% on RPFNA within 6 months prior to study start
Key exclusion· 7
  • ✕Pregnant, nursing, or nursing within past 6 months
  • ✕Known osteoporosis or severe osteopenia (T-score ≤-2 by DEXA)
  • ✕History of symptomatic endometriosis with pelvic pain, poorly controlled migraines, or hot flashes
  • ✕History of deep venous thrombosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00853996
NCT00853996Phase 2Completed
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Phase II Study of Acolbifene in Pre-Menopausal Women at High Risk for Breast Cancer

University of Kansas Medical Center·interventional·Posted Mar 2, 2009·Updated Jan 17, 2018

In Brief

A Phase 2 clinical trial evaluating acolbifene hydrochloride for Breast Cancer. Completed, enrolled 25 participants across 1 site.

Detailed Summary

This phase II trial is studying how well acolbifene works in preventing cancer in premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acolbifene may stop cancer from growing or coming back.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2009
Enrollment StartFeb 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.3 years ago

Interventions

acolbifene hydrochloridedrug

Given orally