Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

Celgene

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Albumin-bound paclitaxel; Drug: Herceptin®; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00093145

CA016

Details and patient eligibility

About

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed adenocarcinoma of the breast
• Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
• Stage IV disease
• Measurable disease
• At least 3 weeks since prior cytotoxic chemotherapy
• At least 4 weeks since radiotherapy with full recovery
• At least 4 weeks since major surgery with full recovery
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• At least 18 years old
• Absolute neutrophil count (ANC) at least 1.5 x 10^9 cells/L
• Platelets at least 100 x 10^9 cells/L
• Hemoglobin at least 9 g/dL
• Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal
• Alkaline Phosphatase less than 1.5X upper limit normal
• Creatinine less than 1.5 gm/dL
• Normal left ventricular ejection fraction
• Negative pregnancy test
• Agree to use method to avoid pregnancy
• Informed Consent is obtained

Exclusion criteria

• Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
• Cumulative life-time dose of doxorubicin is greater than 360 mg/m^2
• Concurrent immunotherapy or hormonal therapy
• Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment
• Serious intercurrent medical or psychiatric illness, including serious active infection
• History of congestive heart failure
• History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer
• Patients who have received an investigational drug within the previous 3 weeks
• Patient is currently enrolled in another clinical study receiving investigational therapies
• Pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Albumin-bound paclitaxel, Carboplatin + Herceptin

Experimental group

Description:

Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.

Treatment:

Drug: Carboplatin

Drug: Herceptin®

Drug: Albumin-bound paclitaxel