Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

Best Overall Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)

Secondary Outcomes (4)

Number of Participants With a Time to Treatment Failure (TTTF) Event
randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months)
Progression Free Survival (PFS)
baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)
Duration of Response
time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)
Overall Survival
baseline to date of death from any cause (up to 34 months)

Study Arms (3)

Gemcitabine + Paclitaxel

EXPERIMENTAL

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.

Drug: gemcitabineDrug: paclitaxel

Gemcitabine + Carboplatin

EXPERIMENTAL

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.

Drug: gemcitabineDrug: carboplatin

Gemcitabine + Cisplatin

EXPERIMENTAL

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

Drug: gemcitabineDrug: cisplatin

Interventions

gemcitabineDRUG

2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles

Also known as: LY188011, Gemzar

Gemcitabine + CarboplatinGemcitabine + CisplatinGemcitabine + Paclitaxel

paclitaxelDRUG

150 mg/m2, IV, every 14 days x 8 cycles

Gemcitabine + Paclitaxel

carboplatinDRUG

Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles

Gemcitabine + Carboplatin

cisplatinDRUG

50 mg/m2, IV, every 14 days x 8 cycles

Gemcitabine + Cisplatin

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.