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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | capecitabine (Thymidylate synthase inhibitor) + tesetaxel (DJ 927) (Tubulin inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Results from CONTESSA: A phase 3 study of tesetaxel plus a reduced dose of capecitabine versus capecitabine alone in patients with HER2-, hormone receptor + (HR+) metastatic breast cancer (MBC) who have previously received a taxane
Published date:
11/17/2020
Excerpt:
CONTESSA, which enrolled 685 patients, met the primary endpoint of improved PFS as assessed by the IRC. Median PFS was 9.8 months for tesetaxel plus a reduced dose of capecitabine versus 6.9 months for capecitabine alone, an improvement of 2.9 months [HR=0.716 (95% CI: 0.573- 0.895); p=0.003]. ORR was 57% for tesetaxel plus a reduced dose of capecitabine versus 41% for capecitabine alone (p=0.0002). OS data are immature. Tesetaxel plus capecitabine was associated with a manageable side effect profile consistent with previous clinical studies....An all-oral regimen of tesetaxel plus a reduced dose of capecitabine significantly improved PFS versus capecitabine alone.
Secondary therapy:
DJ 927
Trial ID:
Source:
Title:
Results from CONTESSA 2: A multinational, multicenter, phase 2 study of tesetaxel (T) plus a reduced dose of capecitabine (C) in patients (pts) with hormone receptor + (HR+), HER2- metastatic breast cancer (MBC) not previously treated with a taxane.
Published date:
05/19/2021
Excerpt:
An all-oral regimen of T plus a reduced dose of C demonstrated a high level of antitumor activity in pts with HR+, HER2- MBC not previously treated with a taxane. The confirmed ORR was 51%, median DoR was 9.5 mo and median PFS was 12.9 mo.
DOI:
10.1200/JCO.2021.39.15_suppl.1061
Trial ID:
