drugset / Trial / NCT03499353
Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
Timeline
- Start
- 2018-08-27
- Primary completion
- 2020-09-23
- Completion
- 2020-09-23
Outcome
Missed primary endpoint
Stopped (Business): “This study was terminated based on Pfizer's change in clinical development strategy not related to safety and efficacy.”
paper Neoadjuvant talazoparib monotherapy was active despite pCR rates not meeting the prespecified threshold; PMID 37318349 ↗
Publications
- Litton JK, Beck JT, Jones JM, Andersen J, Blum JL, Mina LA, Brig R, Danso M, Yuan Y, Abbattista A, Noonan K, Niyazov A, Chakrabarti J, Czibere A, Symmans WF, Telli ML. Neoadjuvant Talazoparib in Patients With Germline BRCA1/2 Mutation-Positive, Early-Stage Triple-Negative Breast Cancer: Results of a Phase II Study. Oncologist. 2023 Oct 3;28(10):845-855. doi: 10.1093/oncolo/oyad139.
- Litton JK, Scoggins ME, Hess KR, Adrada BE, Murthy RK, Damodaran S, DeSnyder SM, Brewster AM, Barcenas CH, Valero V, Whitman GJ, Schwartz-Gomez J, Mittendorf EA, Thompson AM, Helgason T, Ibrahim N, Piwnica-Worms H, Moulder SL, Arun BK. Neoadjuvant Talazoparib for Patients With Operable Breast Cancer With a Germline BRCA Pathogenic Variant. J Clin Oncol. 2020 Feb 10;38(5):388-394. doi: 10.1200/JCO.19.01304. Epub 2019 Aug 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Talazoparib | Small molecule | 1 mg | Oral |