Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

Study Overview
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Brief Summary
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Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine. Aim of the study is to assess the optimal dosage and safety in this setting.

Official Title
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A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically verified diagnosis of breast carcinoma, at first diagnosis restricted previous adjuvant chemotherapy (completed >6 months prior the study) measurable and/or non-measurable disease previous radiotherapy is allowed if:terminated at least 10 days prior the sudy therapy, at least one target lesion for evaluation of tumor response has not been irradiated performance status 0-2 (WHO, Zubrod) adequate bone marrow reserve defined adequate liver / renal functions defined Exclusion Criteria: any prior systematic chemotherapy for metastatic breast cancer expected survival time less than 12 weeks past or current history of malignant neoplasm other than breast carcinoma except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri known brain metastases/leptomeningeal involvement active uncontrolled infection symptomatic peripheral neuropathy > grade 2 according to NCI patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease concomitant illness that is contraindication to the use of corticosteroids other concomitant serious illness or medical condition, which may worsen due to the treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Gemcitabine<br>* A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure<br>* Other names: Gemzar;Drug: docetaxel<br>* A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine B: 80 mg/m2, IV, q 21 days until treatment failure<br>|
| Experimental: B<br> | Drug: Gemcitabine<br>* A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure<br>* Other names: Gemzar;Drug: docetaxel<br>* A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine B: 80 mg/m2, IV, q 21 days until treatment failure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure (TTTF) |  | baseline to stopping treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | baseline to measured progressive disease | 
| Duration of response |  | time of response to progressive disease | 
| Overall survival |  | baseline to date of death from any cause | 
| Time to progressive disease |  | baseline to measured progressive disease | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer