Clinical Trial: NCT04142892
Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor + and HER2- Breast Cancer
Status:
COMPLETEDPhase:
Early Phase 1| Lead Sponsor: | SOLTI Breast Cancer Research Group |
| Information Provided By: | SOLTI Breast Cancer Research Group |
| Last Update Posted: | 2022-04-01 |
Study Overview
Brief 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.
Official Title
A Window of Opportunity Trial of Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor-Positive and HER2-negative Breast Cancer
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Onapristone
Other Study ID Numbers
- ONAWA (SOLTI-1802)
- 2019-001433-13
- 2019
Start Date (Actual)
2020-11-06
Primary Completion Date (Actual)
2021-04-30
Study Completion Date (Actual)
2021-04-30
Enrollment (Actual)
10
Study Type
Interventional
Phase
Early Phase 1
| Lead Sponsor: | SOLTI Breast Cancer Research Group |
| Information Provided By: | SOLTI Breast Cancer Research Group |
| Last Update Posted: | 2022-04-01 |
Study Overview
Brief 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.
Official Title
A Window of Opportunity Trial of Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor-Positive and HER2-negative Breast Cancer
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Onapristone
Other Study ID Numbers
- ONAWA (SOLTI-1802)
- 2019-001433-13
- 2019
Start Date (Actual)
2020-11-06
Primary Completion Date (Actual)
2021-04-30
Study Completion Date (Actual)
2021-04-30
Enrollment (Actual)
10
Study Type
Interventional
Phase
Early Phase 1