Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

Tumor Response Rate
Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants\*100.
Baseline up to 30 days of follow-up after 21 cycles of treatment

Secondary Outcomes (5)

Duration of Response (DOR)
Time of response to progressive disease (up to 19 months)
Time to Progressive Disease (PD)
Baseline to measured PD (up to 25.1 months)
Time To Treatment Failure (TTTF)
Baseline to end of treatment (up to 21.9 months)
Time to Response
Baseline to response (up to 7.8 months)
Number of Participants With Adverse Events (AE)
every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)

Study Arms (2)

Pemetrexed/Carboplatin

EXPERIMENTAL

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.

Drug: PemetrexedDrug: Carboplatin

Gemcitabine/Vinorelbine

ACTIVE COMPARATOR

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.

Drug: GemcitabineDrug: Vinorelbine

Interventions

PemetrexedDRUG

600 mg/m\^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.

Also known as: LY231514, Alimta

Pemetrexed/Carboplatin

CarboplatinDRUG

AUC 5 mg\*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity.

Pemetrexed/Carboplatin

GemcitabineDRUG

1200 mg/m\^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

Also known as: LY188011, Gemzar

Gemcitabine/Vinorelbine

VinorelbineDRUG

30 mg/m\^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

Gemcitabine/Vinorelbine

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

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

You may qualify if:

Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions should not be amenable to surgery or radiation of curative intent.
Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale.
One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st-line treatment.
One prior chemotherapy containing taxanes as (neo) adjuvant or palliative 1st-line treatment.
Prior radiation therapy is allowed to less than 25% of the bone marrow. Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Positron emission tomography \[PET\] scans and ultrasounds may not be used.
Antitumoral hormonal treatment must be discontinued prior to enrollment.
Estimated life expectancy of at least 3 months.
Participant compliance and geographic proximity that allow adequate follow-up.
Adequate organ function
Female participants of childbearing potential must test negative for pregnancy within 7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
Participants must sign an informed consent document.
Female participants must be at least 18 years of age.

You may not qualify if:

Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine
Have received more than one line of chemotherapy in Metastatic Breast Cancer. Participants having received more than one combination of anthracycline plus taxane.
Are pregnant or breast-feeding.
Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to complete the study.
Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam), unless the Creatinine Clearance is greater than or equal to 80 ml/min.
Have central nervous system (CNS) metastases.
Have clinically relevant (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry.
Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
Concurrent administration of any other antitumor therapy.

Contact the study team to confirm eligibility.