Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

Study Overview
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Brief Summary
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The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.

Official Title
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A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

Conditions
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Primary Breast Cancer

Intervention / Treatment
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* Drug: paclitaxel/anthracycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients, age ≦65 years Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel) Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision Postoperative residual positive lymph nodes or G1/G2/G3 of Miller & Payne Grading System Adequate recovery from recent surgery No history of other malignancies No currently uncontrolled diseased or active infection Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential Adequate cardiovascular function reserve with a myocardial infarction within the past six month Adequate hematologic function with: Absolute neutrophil count (ANC) ≥1500/mm3 Platelets ≥100,000/ mm3 Hemoglobin ≥10 g/dL Adequate hepatic and renal function with: Serum bilirubin ≤1.5×UNL Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis) BUN between 1.7 and 8.3 mmol/L Cr between 40 and 110 umol/L Knowledge of the investigational nature of the study and Ability to give informed consent Ability and willingness to comply with study procedures. Exclusion Criteria: Known or suspected distant metastases Concurrent malignancy or history of other malignancy Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection Geographical, social, or psychological problems that would compromise study compliance Known or suspected hypersensitivity to anthracycline or paclitaxel

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Chemotherapy<br> | Drug: paclitaxel/anthracycline<br>* standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)<br>* Other names: Alternative Non-cross-resistant Adjuvant Chemotherapy;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distant disease-free survival (DDFS) |  | 3 years after surgery |