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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | 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:
Phase 3 registration study comparing tesetaxel (27 mg/m2 on Day 1 of a 21-day cycle) plus a reduced dose of capecitabine (1,650 mg/m2/day on Days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day on Days 1-14 of a 21-day cycle) in patients with HER2-, HR+ MBC...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)...An all-oral regimen of tesetaxel plus a reduced dose of capecitabine significantly improved PFS versus capecitabine alone.
Secondary therapy:
capecitabine
Source:
Title:
Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC
Excerpt:
...Cohort 1: ORR in patients with PD-L1 positive status`Cohort 1: PFS in patients with PD-L1 positive status`Cohort 2: ORR in patients with HR-positive, HER2-negative disease`Cohort 2: PFS in patients with HR-positive, HER2-negative disease`Cohort 3: ORR in patients with HR-positive, HER2-negative disease`Cohort 3: PFS in patients with HR-positive, HER2-negative disease...
Trial ID:
Source:
Title:
n/a
Excerpt:
...Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy. ...
Trial ID:
More C2 evidence
Source:
Title:
Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC
Excerpt:
...Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy....
Trial ID:
Source:
Title:
Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
Excerpt:
...Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy....
Trial ID:
Less C2 evidence
Source:
Title:
Activity of tesetaxel, an oral taxane, given as a single-agent in patients (Pts) with HER2-, hormone receptor + (HR+) locally advanced or metastatic breast cancer (MBC) in a phase 2 study
Published date:
05/16/2016
Excerpt:
T, as a single agent, was well tolerated with significant activity in pts with HER2-, HR+ MBC.
DOI:
10.1200/JCO.2018.36.15_suppl.1042
Trial ID:
