Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: paclitaxel; Drug: cisplatin; Drug: gemcitabine; Drug: carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191854

7451

B9E-AA-S355 (Other Identifier)

Details and patient eligibility

About

The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.

Enrollment: 147 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients with histological or cytological proven diagnosis of breast cancer
• Stage IV disease
• Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
• Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease
• Adequate organ function

Exclusion criteria

• Prior chemotherapy for metastatic disease
• Previous radiation therapy is allowed but must not have included whole pelvis radiation
• Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
• Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))
• Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 3 patient groups

Gemcitabine + Paclitaxel

Experimental group

Description:

gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles.

Treatment:

Drug: gemcitabine

Drug: paclitaxel

Gemcitabine + Carboplatin

Experimental group

Description:

gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles.

Treatment:

Drug: carboplatin

Drug: gemcitabine

Gemcitabine + Cisplatin

Experimental group

Description:

gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles

Treatment:

Drug: gemcitabine

Drug: cisplatin