Conditions: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to help answer the following research questions:

* whether the chemotherapy combination therapy Pemetrexed-Carboplatin or Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the tumor smaller or disappear and for how long
* to learn more about the side effects in each chemotherapy combination treatment arm
* to assess how participants with advanced breast cancer report health changes while receiving any of the chemotherapy combination arm

Detailed description:

Arms:
arm 1: Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1.

Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC (Area under the plasma drug concentration versus time curve) 5.0 mg\*min/mL. The cycle of treatment was 21 days. arm 2: Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m\^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.

Interventions: intervention 1: Pemetrexed intervention 2: Carboplatin intervention 3: Gemcitabine intervention 4: Vinorelbine
Intervention descriptions: intervention 1: 600 mg/m\^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity. intervention 2: AUC 5 mg\*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity. intervention 3: 1200 mg/m\^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity. intervention 4: 30 mg/m\^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

Protocol document: