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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
600 mg/m\^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.
AUC 5 mg\*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity.
1200 mg/m\^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
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.
Time frame: Baseline up to 30 days of follow-up after 21 cycles of treatment
Duration of Response (DOR)
DOR-RECIST criteria of (Complete Response \[CR =Disappearance of lesions\] or Partial Response \[PR=≥30% size decrease of lesions\]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date.
Time frame: Time of response to progressive disease (up to 19 months)
Time to Progressive Disease (PD)
Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy.
Time frame: Baseline to measured PD (up to 25.1 months)
Time To Treatment Failure (TTTF)
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30 mg/m\^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gütersloh, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hamburg, Germany
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Stuttgart, Germany
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Bergamo, Italy
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Bologna, Italy
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Livorno, Italy
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Meldola, Italy
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Rome, Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Giovanni Rotondo, Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Durban, South Africa
...and 12 more locations
TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation.
Time frame: Baseline to end of treatment (up to 21.9 months)
Time to Response
Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions.
Time frame: Baseline to response (up to 7.8 months)
Number of Participants With Adverse Events (AE)
A listing of adverse events is presented in the Reported Adverse Event Module.
Time frame: every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)