CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 10 enrolled
Drug / intervention
Onapristonedrug
Likely dose
Onapristone 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT04142892
NCT04142892Early Ph 1Completed
CompareCT.gov

A Window of Opportunity Trial of Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor-Positive and HER2-negative Breast Cancer

SOLTI Breast Cancer Research Group·interventional·Posted Oct 29, 2019·Updated Apr 1, 2022

In Brief

A Early Phase 1 clinical trial evaluating Onapristone for Breast Cancer. Completed, enrolled 10 participants across 4 sites.

Detailed Summary

ONAWA is a window of opportunity, prospective, multicenter, phase 0 trial which evaluates the effect of onapristone (ONA) on proliferation after 3 weeks of treatment in postmenopausal women with ER+/PgR+ and HER2-negative early breast cancer amenable to pre-operative endocrine therapy and surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesSpain
Collaborators--

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedOct 29, 2019
Enrollment StartNov 6, 2020
Primary CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.7 years ago

Interventions

Onapristonedrug

50 mg given orally (PO), twice a day (BID), in a continuous schedule (QD) during 3 weeks (+/-3 days)