Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer

R-Pharm

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00593827

CA163-132

USOR 06-106

Details and patient eligibility

About

The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.

Enrollment: 176 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
• Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
• Prior chemotherapy is permitted with no limit on the number of prior regimens
• Two weeks or more have elapsed since last chemotherapy or radiation treatment
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
• Is female, ≥ 18 yrs of age
• Protocol defined appropriate laboratory values
• Negative pregnancy test within 7 calendar days prior to registration
• Has signed a patient informed consent

Exclusion criteria

• Had prior treatment with ixabepilone or other epothilones
• Has HER2+ disease
• Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
• Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
• Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
• Has peripheral neuropathy > Grade 1
• Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible
• Is pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

ixabepilone 16 mg/m\^2 weekly for 3 weeks followed by 1 week rest

Treatment:

Drug: Ixabepilone

Drug: Ixabepilone

Arm 2

Active Comparator group

Description:

ixabepilone 40 mg/m\^2 every 3 weeks

Treatment:

Drug: Ixabepilone

Drug: Ixabepilone