Evidence Level:Sensitive: B - Late Trials
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
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.
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
n/a
Excerpt:...Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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....
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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...
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
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
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