Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.

Official Title
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Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer. Unresectable, locally recurrent breast cancer or stage IV disease. Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse. Exclusion Criteria: Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease. Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment. Active infection or other serious condition. Pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: gemcitabine<br>* 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression<br>* Other names: Gemzar;Drug: paclitaxel<br>* 175 mg/m2, intravenous (IV), every 21 days until disease progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. | baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Treatment Failure | Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. | baseline to stopping treatment | 
| Progression-Free Survival | Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints. | baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment) | 
| Duration of Response | Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival. | time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment) | 
| Overall Survival Probability | Original outcome was overall survival = time from date of enrollment to date of death due to any cause. Survival time was censored at date of last contact for participants who were still alive or lost to follow-up. Because only 8 participants had documented death while on study, results are reported as 6- and 12-month overall survival probability. | baseline to date of death from any cause |