Table 1.
Study | Disease | Phase | Total (n) | BRCAm (n) | TNBC (n) | BRCAm ER+ (n) | Treatment | Response in overall population | Response in patients with wtBRCA1/2 | Response in patients with gBRCA1/2m | Response in patients with BRCA1m | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Advanced and metastatic breast cancer | ||||||||||||||
TNT45 | Metastatic TNBC or BRCA1/2 mutation BC | III | 376 | 43 | 363 | 12 | Carboplatin vs docetaxel | ORR: 31% with carboplatin vs 36% with docetaxel | NR | 68% with carboplatin vs 33% with docetaxel | NR | |||
TBCRC00948 | Metastatic TNBC | II | 86 | 11 | 86 | 0 | Cisplatin or carboplatin | ORR: 25.6% (22/86) | ORR: 19.7% (13/66) | ORR: 54.5% (6/11) | NR | |||
NCT0161172747 | Metastatic BC with a BRCA1 mutation | II | 20 | 20a | 14 | 5 | Cisplatin | NR | NR | NR | ORR: 80% CR: 45% | |||
Brocade 2 NCT0150660982 | Locally recurrent or metastatic BC with a gBRCA1/2 mutation | II | 99 | 99 | 42 | 56 (ER+ and/or PgR+) | Paclitaxel/carboplatin/placebo (PCP) | 61% | NR | 61% | NR | |||
Early-stage disease | ||||||||||||||
NCT0163022685 | Stage I–III BC with a BRCA1 mutation | II | 107 | 107b | 82 | 16 | Cisplatin | NR | NR | NR | pCR: 61% | |||
GeparSixto/GBG 66 NCT0142688087,88 | Stage I–III TNBC or HER2+ BC | II/III | 588 | 50 |
315 291 BRCA known |
0 | Backbone regimen ± carboplatin |
With vs without carboplatin: TNBC pCR: 53% vs 37% 291 BRCA known status: 57% vs 41% |
With vs without carboplatin: TNBC pCR: 55% vs 36% |
With vs without carboplatin: TNBC pCR: 65% vs 67% |
NR |
BC breast cancer, CR complete response, ER+ oestrogen receptor-positive, gBRCA1/2 germline BRCA1/2, HER2+ human epidermal growth factor receptor 2-positive, NR not reported, ORR overall response rate, pCR pathologic complete response, PgR+ progesterone receptor-positive, TNBC triple-negative breast cancer, wtBRCA1/2 wild-type BRCA1/2
aAll were HER2-negative, 15 were ER-negative, 17 were PgR-negative, and 14 were TNBC
b100 were HER2-negative (5 HER2 status unknown), 86 were ER-negative (5 ER status unknown), 91 were PgR-negative (6 PgR status unknown), and 82 were TNBC