Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor + and HER2- Breast Cancer (ONAWA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04142892|
Recruitment Status : Completed
First Posted : October 29, 2019
Last Update Posted : April 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Onapristone||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||window of opportunity, prospective, multicenter, phase 0 trial|
|Masking:||None (Open Label)|
|Official Title:||A Window of Opportunity Trial of Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor-Positive and HER2-negative Breast Cancer|
|Actual Study Start Date :||November 6, 2020|
|Actual Primary Completion Date :||April 30, 2021|
|Actual Study Completion Date :||April 30, 2021|
50 mg given orally (PO), twice a day (BID), in a continuous schedule (QD). 3 weeks of (+/-3 days) of ONA treatment
50 mg given orally (PO), twice a day (BID), in a continuous schedule (QD) during 3 weeks (+/-3 days)
- Complete Cell Cycle Arrest (CCCA) [ Time Frame: after 3 weeks of ONA therapy ]CCCA rate determined by Ki67 < 2.7%
- IHC of tumor expression [ Time Frame: after 3 weeks of ONA therapy ]IHC of tumor expression of ER, PgR, CD24, CD44, ALDH1, Ser294-PgR, Ki67
- PAM50 (Prediction Analysis of Microarray 50) subtype change [ Time Frame: after 3 weeks of ONA therapy ]PAM50 subtype changes upon ONA therapy
- antiproliferative effect [ Time Frame: after 3 weeks of ONA therapy ]Suppression of PAM50 11-gene proliferation signature according to PAM50 subtypes upon treatment.. These changes will be analyzed according to the formula: Mean suppression = 100 - [geometric mean (post-treatment / pretreatment · 100)].
- proliferation score [ Time Frame: after 3 weeks of ONA therapy ]mean suppression of PAM50 11-gene proliferation signature according to PAM50 subtypes
- gene expression changes [ Time Frame: after 3 weeks of ONA therapy ]
- expression of 770 genes across of 23 categories of BC tumor biology
- changes in the expression of the 16-PgR target genes
- molecular markers in blood [ Time Frame: after 3 weeks of ONA therapy ]Estradiol and progesterone levels
- identification putative prognostic and predictive biomarkers [ Time Frame: after 3 weeks of ONA therapy ]
- Development of a gene signature of response to ONA based on changes in the expression of 770 genes by the nCounter Breast 360TM panel in the tumor.
- Analysis of the presence of ctDNA and its dynamics after ONA treatment.
- Adverse Events (AEs) [ Time Frame: after 3 weeks of ONA therapy ]Incidence, duration and severity of Adverse Events (AEs) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5.0, including treatment discontinuations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142892
|Hospital Universitari Vall d'Hebron|
|Barcelona, Spain, 08035|
|Hospital Clínic de Barcelona|
|Hospital Universitari Arnau de Vilanova de Lleida|
|Lleida, Spain, 25198|
|Hospital Universitario Sant Joan de Reus|