Ann Oncol: Phase III BROCADE3 Study Shows Veliparib (Veliparib) Plus Carboplatin/Paclitaxel After Veliparib Maintenance Therapy Improves Outcomes in Patients With BRCA1/2 Germline Mutated Breast Cancer

The phase III BROCADE3 study showed that adding veliparib to carboplatin/paclitaxel improved PFS in patients with advanced HER2-negative, BRCA1/2 germline-mutated breast cancer (HR=0.
71, 95%CI 0.
57-0.
88; P=0.
002)
.

Some patients who did not progress after veliparib (veliparib) combined with carboplatin/paclitaxel were randomly assigned to veliparib (veliparib) or placebo maintenance therapy until disease progression

The phase III BROCADE3 study showed that adding veliparib to carboplatin/paclitaxel improved PFS in patients with advanced HER2-negative, BRCA1/2 germline-mutated breast cancer (HR=0.

The study randomized patients into 2 groups: veliparib plus carboplatin/paclitaxel or placebo plus carboplatin/paclitaxel
.

Patients in both groups received maintenance therapy with veliparib or placebo until progression

The study randomized patients into 2 groups: veliparib plus carboplatin/paclitaxel or placebo plus carboplatin/paclitaxel

In total, 509 patients with confirmed BRCA1/2 germline mutations were randomly assigned to veliparib + carboplatin/paclitaxel (n=337) or placebo + carboplatin/paclitaxel (n=172)

Investigator-assessed median PFS was 13.
4 (12.
1-18.
7) and 12.
7 (10.
6-14.
5) months in the overall ITT population with Veliparib and placebo, respectively (HR 0.
82, 95% CI 0.
63-1.
07; p=0.
141)
.

Investigator-assessed median PFS was 13.
4 (12.
1-18.
7) and 12.
7 (10.
6-14.
5) months in the overall ITT population with Veliparib and placebo, respectively (HR 0.
82, 95% CI 0.
63-1.
07; p=0.
141)
.

Investigator-assessed median PFS was 13.

In patients who discontinued treatment and did not progress on veliparib or placebo maintenance therapy, the median progression-free survival (PFS) was 25.
7 months and 14.
6 months in the Veliparib and placebo groups, respectively.
month (HR 0.
49, 95% CI 0.
34-0.
73; P<0.
001)
.

In patients who discontinued treatment and did not progress on veliparib or placebo maintenance therapy, the median progression-free survival (PFS) was 25.
7 months and 14.
6 months in the Veliparib and placebo groups, respectively.
month (HR 0.
49, 95% CI 0.
34-0.
73; P<0.
001)
.

In patients who discontinued treatment and did not progress on veliparib or placebo maintenance therapy, the median progression-free survival (PFS) was 25.

In the veliparib group, 99.
4% of patients experienced AEs of any grade during combination therapy, compared with 91.
9% during veliparib monotherapy
.

The most common ≥ grade 3 TEAEs were (3.

In the veliparib group, 99.

Taken together, the study demonstrated that veliparib combination therapy continued maintenance therapy with a tolerable safety profile and may prolong PFS in patients with BRCA1/2 germline-mutated breast cancer
.

Taken together, the study demonstrated that veliparib combination therapy continued maintenance therapy with a tolerable safety profile and may prolong PFS in patients with BRCA1/2 germline-mutated breast cancer
.

Taken together, the study demonstrated that veliparib combination therapy continued maintenance therapy with a tolerable safety profile and may prolong PFS in patients with BRCA1/2 germline-mutated breast cancer

Original source:

Han HS, Arun BK, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bach BA, Kundu MG, Khandelwal N, Feng D, Bhattacharya S, Maag D, Ratajczak CK, Diéras V.
Veliparib monotherapy following carboplatin/ paclitaxel plus veliparib combination therapy in patients with germline BRCA-associated advanced breast cancer: results of exploratory analyses from the phase III BROCADE3 trial.
Ann Oncol.
2022 Mar;33(3):299-309.
doi: 10.
1016/j.
annonc.
2021.
11.
018.
Epub 2021 Nov 30.
PMID: 34861374.

Han HS, Arun BK, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bach BA, Kundu MG, Khandelwal N, Feng D, Bhattacharya S, Maag D, Ratajczak CK, Diéras V.
Veliparib monotherapy following carboplatin/ paclitaxel plus veliparib combination therapy in patients with germline BRCA-associated advanced breast cancer: results of exploratory analyses from the phase III BROCADE3 trial.
Ann Oncol.
2022 Mar;33(3):299-309.
doi: 10.
1016/j.
annonc.
2021.
11.
018.
Epub 2021 Nov 30.
PMID: 34861374.
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