Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC
- Registration Number
- NCT03858972
- Lead Sponsor
- Odonate Therapeutics, Inc.
- Brief Summary
CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane. The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). 152 patients were enrolled.
- Detailed Description
CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with HER2 negative, HR Positive, LA/MBC not previously treated with a taxane in the neoadjuvant, adjuvant or metastatic setting. This Study complements CONTESSA, a multinational, multicenter, randomized, Phase 3 study in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. 152 patients were enrolled, including 149 who received treatment. Patients are administered tesetaxel at 27 mg/m2 orally once every 21 days on the first day of each 21-day cycle plus capecitabine at 825 mg/m2 orally twice daily (for a total daily dose of 1,650 mg/m2) for 14 days of each 21-day cycle. Patients in the dense pharmacokinetics (PK) cohort receive a single dose of capecitabine monotherapy prior to starting the combination regimen. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. The primary efficacy endpoint is ORR as assessed by the IRC. The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS). CONTESSA 2 also investigates the PK of tesetaxel.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 152
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tesetaxel (oral) and capecitabine (oral) Tesetaxel Cohort 1: Tesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle. Cohort 2: On Cycle 1, Day -1, either a single morning dose of capecitabine at 825 mg/m2 (Cohort 2A) or 1,250 mg/m2 (Cohort 2B). On Cycle 1, Day 1, a single dose of tesetaxel (27 mg/m2), followed 2 hours later by capecitabine (825 mg/m2), followed by an evening dose of capecitabine (825 mg/m2). Capecitabine (825 mg/m2) twice daily (total daily dose of 1,650 mg/m2) beginning with the morning dose on Day 2 through evening dose on Day 14 of Cycle 1. Starting with Cycle 2, tesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle. Tesetaxel (oral) and capecitabine (oral) Capecitabine Cohort 1: Tesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle. Cohort 2: On Cycle 1, Day -1, either a single morning dose of capecitabine at 825 mg/m2 (Cohort 2A) or 1,250 mg/m2 (Cohort 2B). On Cycle 1, Day 1, a single dose of tesetaxel (27 mg/m2), followed 2 hours later by capecitabine (825 mg/m2), followed by an evening dose of capecitabine (825 mg/m2). Capecitabine (825 mg/m2) twice daily (total daily dose of 1,650 mg/m2) beginning with the morning dose on Day 2 through evening dose on Day 14 of Cycle 1. Starting with Cycle 2, tesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle.
- Primary Outcome Measures
Name Time Method ORR as assessed by the IRC Approximately 2.0-2.5 years
- Secondary Outcome Measures
Name Time Method OS Approximately 3.0-3.5 years DoR as assessed by the IRC Approximately 2.0-2.5 years PFS as assessed by the IRC Approximately 2.0-2.5 years DCR as assessed by the IRC Approximately 2.0-2.5 years Central nervous system (CNS) ORR as assessed by the CNS IRC in patients with CNS metastases at baseline Approximately 2.0-2.5 years CNS DoR as assessed by the CNS IRC in patients with CNS metastases at baseline Approximately 2.0-2.5 years CNS PFS as assessed by the CNS IRC in patients with CNS metastases at baseline or a history of CNS metastases and in the intent-to-treat (ITT) population Approximately 2.0-2.5 years CNS OS in patients with CNS metastases at baseline or a history of CNS metastases Approximately 3.0-3.5 years
Trial Locations
- Locations (25)
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hopital Maisonneuve-Rosemont
🇨🇦Montréal, Canada
West Cancer Center
🇺🇸Germantown, Tennessee, United States
Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre
🇨🇦Sherbrooke, Canada
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
National Cancer Center
🇰🇷Goyang, Korea, Republic of
McGill University Health Center
🇨🇦Montréal, Canada
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Hospital Teresa Herrera Materno-Infantil (CHUAC)
🇪🇸A Coruña, Spain
Center Hospitalier de Montreal CHUM McPeak Sirois
🇨🇦Montréal, Canada
Border Medical Oncology
🇦🇺Albury, New South Wales, Australia
CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital
🇨🇦Montréal, Canada
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
Sarah Cannon Research Institute - Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Rocky Mountain Cancer Center
🇺🇸Lakewood, Colorado, United States
Florida Cancer Specialists and Research Institute
🇺🇸Saint Petersburg, Florida, United States
New York Cancer and Blood Specialists
🇺🇸East Setauket, New York, United States
CHU de Quebec-University Laval
🇨🇦Québec, Canada
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei, Taiwan
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of