Clinical trial NCT01609127: Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer
Official title: A Randomized, Phase II Study of Tesetaxel Once Every 3 Weeks Versus Tesetaxel Once Weekly for 3 Weeks Versus Capecitabine Twice Daily for 14 Days as First-line Therapy for Subjects With Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Non-resectable Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 213
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.


Eligibility criteria: Key inclusion criteria:

1. Female
2. At least 18 years of age
3. Locally advanced non-resectable or metastatic breast cancer
4. HER2 negative disease
5. Measurable disease per revised RECIST, Version 1.1
6. Eastern Cooperative Oncology Group performance status 0 or 1
7. Chemotherapy naïve, OR 1 prior chemotherapy regimen in the neoadjuvant or adjuvant setting provided the patient has had a disease-free interval of ≥ 12 months after ending this chemotherapy. If the neoadjuvant or adjuvant chemotherapy included a taxane, ≥ 2 years must have passed since this treatment ended.
8. Documented disease recurrence or progression
9. Adequate bone marrow, hepatic, and renal function
10. Ability to swallow an oral solid-dosage form of medication
11. Written informed consent

Key exclusion criteria:

1. Known metastasis to the central nervous system
2. Other cancer within the preceding 5 years other than curatively treated basal or squamous cell carcinoma of the skin or carcinoma of the cervix in situ
3. Significant medical disease other than breast cancer
4. Presence of neuropathy \> Grade 1 (NCI CTC)
5. History of hypersensitivity to a taxane or capecitabine, other fluoropyrimidine agents, or any of their ingredients
6. History of severe or unexpected reaction to fluoropyrimidine therapy
7. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
8. Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway
9. Known dihydropyrimidine dehydrogenase deficiency
10. Pregnancy or lactation

Primary outcomes:
measure: Response rate
timeFrame: 4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized
Secondary outcomes:
measure: Clinical benefit rate
timeFrame: 12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized
measure: Progression-free survival
timeFrame: 12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized
measure: Progression-free survival rate
timeFrame: 6 and 12 months after patients' date of randomization
measure: Adverse events
timeFrame: up to 30 days after patients' last dose of study medication
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrew D Seidman, MD
role: PRINCIPAL_INVESTIGATOR
References: