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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Locally Advanced Non-resectable Breast Cancer, Metastatic Breast Cancer

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

the percentage of patients with a confirmed complete or partial response, as defined in the revised Response Evaluation Criteria in Solid Tumors (revised RECIST [Version 1.1])

Outcome Time Frame:

4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized

Safety Issue:

No

Principal Investigator

Andrew D Seidman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

TOB206

NCT ID:

NCT01609127

Start Date:

May 2012

Completion Date:

July 2014

Related Keywords:

  • Locally Advanced Non-resectable Breast Cancer
  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

The West ClinicMemphis, Tennessee  38120