scholarly journals Phase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations

2021 ◽  
Vol 189 (3) ◽  
pp. 641-651
Author(s):  
Jing Xu ◽  
Tanya E. Keenan ◽  
Beth Overmoyer ◽  
Nadine M. Tung ◽  
Rebecca S. Gelman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Breast Cancer Patients

Gemcitabine/Vinorelbine in Metastatic Breast Cancer Patients Previously Treated with Anthracyclines: Results of a Phase II Trial

2003 ◽  
Vol 4 (1) ◽  
pp. 46-50 ◽  
Author(s):  
F. Lobo ◽  
J.A. Virizuela ◽  
F.J. Dorta ◽  
J. Florián ◽  
M. Lomas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Previously Treated

scholarly journals Ixabepilone Administered Weekly or Every Three Weeks in HER2-Negative Metastatic Breast Cancer Patients; A Randomized Non-Comparative Phase II Trial

PLoS ONE ◽  
2013 ◽  
Vol 8 (7) ◽  
pp. e69256 ◽  
Author(s):  
George Fountzilas ◽  
Vassiliki Kotoula ◽  
Dimitrios Pectasides ◽  
George Kouvatseas ◽  
Eleni Timotheadou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Breast Cancer Patients

Phase II Trial of Pegylated Liposomal Doxorubicin in Combination With Gemcitabine in Metastatic Breast Cancer Patients

2012 ◽  
Vol 35 (1) ◽  
pp. 18-21 ◽  
Author(s):  
Jean-Philippe Jacquin ◽  
Cyrus Chargari ◽  
Julie Thorin ◽  
Dominique Mille ◽  
Adrien Mélis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Liposomal Doxorubicin ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin ◽  
Breast Cancer Patients

scholarly journals Phase II Trial of Veliparib and Temozolomide in Metastatic Breast Cancer Patients With and Without BRCA1/2mutations

2021 ◽  
Author(s):  
Jing Xu ◽  
Tanya E Keenan ◽  
Beth Overmoyer ◽  
Nadine Muskatel Tung ◽  
Rebecca Gelman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Phase Ii Trial ◽  
Brca Mutation ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Expansion Cohort

Abstract Purpose: We evaluated the efficacy and safety of poly-(adenosine diphosphate-ribose) polymerase (PARP) 1 and 2 inhibitor veliparib and temozolomide in metastatic breast cancer patients with and without germline BRCA1/2 mutations.Methods: In this single-arm phase II trial, patients with metastatic breast cancer received veliparib 30 to 40 mg twice daily on days 1 to 7 with concurrent temozolomide 150 mg/m2 on days 1 to 5 of a 28-day cycle. The primary cohort was unselected for BRCA mutation status, and an expansion cohort enrolled only BRCA1/2 carriers. The primary endpoint was objective response rate (ORR) in each cohort. Secondary endpoints included progression free survival (PFS), clinical benefit rate (CBR), and evaluation of safety and tolerability.Results: In the primary cohort of 41 unselected patients, which included 9 BRCA mutation carriers, the ORR was 10% and clinical benefit rate at 4 months (CBR) was 27%. In the expansion cohort of 21 BRCA1/2 carriers, the ORR was 14% and CBR was 43%. Among all 30 BRCA1/2 carriers, the ORR was 23% versus 0% among non-carriers. In the subset of BRCA1/2 carriers, the ORR was 32% among platinum-naïve patients versus 9% among platinum-exposed patients. The median PFS was 3.3 months among BRCA1/2 carriers compared to 1.8 months among non-carriers (HR: 0.48, p = 0.006). A longer median PFS of 6.2 months was observed among BRCA1/2 carriers who had no prior platinum therapy. The most common grade 3 and 4 toxicities were thrombocytopenia (32%) and neutropenia (21%) that generally improved with dose modifications.Conclusion: Veliparib and temozolomide demonstrated clinical activity in platinum-naïve BRCA-associated metastatic breast cancer with manageable toxicity at doses of veliparib well below the single agent active dose. Although the study did not meet its primary endpoint in unselected nor BRCA-associated breast cancer, this regimen was further evaluated in the BROCADE 2 study. Trial registration: NCT01009788 (ClinicalTrials.gov), November 9, 2009

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