Tesetaxel as First-line Therapy for Metastatic Breast Cancer
- Conditions
- Breast Neoplasm
- Interventions
- Registration Number
- NCT01221870
- Lead Sponsor
- Genta Incorporated
- Brief Summary
The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer.
Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 81
- Female
- At least 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Stage IV disease
- HER2 status negative
- Measurable disease (revised RECIST; Version 1.1)
- Eastern Cooperative Oncology Group performance status 0 or 1
- Life expectancy of at least 3 months
- Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
- Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
- Prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated
- Adequate bone marrow, hepatic, and renal function, as specified in the protocol
- At least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
- Ability to swallow an oral solid-dosage form of medication
Primary
- Known metastasis to the central nervous system
- History of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ
- Significant medical disease other than Stage IV breast cancer
- Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
- History of hypersensitivity to a taxane
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tesetaxel once weekly Tesetaxel once weekly Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months Tesetaxel once every 3 weeks Tesetaxel once every 3 weeks Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months
- Primary Outcome Measures
Name Time Method Response rate (revised RECIST) 12 months from date of first dose of study medication for last patient enrolled Proportion of patients with a confirmed complete or partial response
- Secondary Outcome Measures
Name Time Method Disease control rate 12 months from date of first dose of study medication for last patient enrolled Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration
Progression-free rate 6 months from date of first dose of study medication for last patient enrolled Proportion of patients without disease progression 6 months following the first dose of study medication
Durable response rate 12 months from date of first dose of study medication for last patient enrolled Proportion of patients with a confirmed complete or partial response ≥ 6 months in duration
Duration of response 12 months from date of first dose of study medication for last patient enrolled Date when response criteria are first met to the date when progression is first documented
Time to progression 12 months from date of first dose of study medication for last patient enrolled Date of first dose of study medication to the date when progression is first documented
Adverse events Up to 30 days after the last dose of study medication for a specific patient Incidence of adverse events
Trial Locations
- Locations (4)
The Moses H. Cone Regional Cancer Center
🇺🇸Greensboro, North Carolina, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States