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Association details:
| Biomarker: | PIK3CA mutation + ER positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | taselisib (GDC-0032) (PIK3CA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial
Published date:
11/10/2020
Excerpt:
Postmenopausal women with disease recurrence/progression during/after an aromatase inhibitor were randomized 2 : 1 to receive taselisib (4 mg; taselisib arm) or placebo (placebo arm) plus fulvestrant (500 mg)...INV-PFS was significantly improved in the taselisib {7.4 months [95% confidence interval (CI), 7.26-9.07]} versus placebo arm (5.4 months [95% CI, 3.68-7.29]) (stratified hazard ratio [HR] 0.70; 95% CI, 0.56-0.89; P = 0.0037) and confirmed by BICR-PFS (HR 0.66). Secondary endpoints, including objective response rate, clinical benefit rate, and duration of objective response, showed consistent improvements in the taselisib arm.
Secondary therapy:
fulvestrant
DOI:
10.1016/j.annonc.2020.10.596
Trial ID:
Source:
Title:
Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA-mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER.
Excerpt:
Taselisib + FULV significantly improved INV-PFS, v PBO + FULV, in pts with ER-positive, HER2-negative, PIK3CA-MUT locally advanced or MBC.
Secondary therapy:
fulvestrant
DOI:
10.1200/JCO.2018.36.18_suppl.LBA1006
Trial ID:
