Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.

Detailed Description
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All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.

Official Title
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A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

Conditions
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Invasive Ductal Breast Cancer, Tubular Breast Cancer, Mucinous Breast Cancer, Inflammatory Breast Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Cisplatin
* Drug: Epirubicin
* Drug: Cyclophosphamide
* Drug: 5-fluoruracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged ≥18years and ≤70 years; Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy. Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST). Endocrine therapy and trastuzumab were allowed to use. ECOG 0-2; Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL; No obvious main organs dysfunction. Exclusion Criteria: Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug; Patient is pregnant or breast feeding; Metastatic breast cancer; Any evidence of sense or motor nerve disorders; Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection; Any concurrent malignancy other than breast cancer; Know severe hypersensitivity to any drugs in this study.

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 |
| --- | --- |
| Active Comparator: Switch to CEF<br>Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks. | Drug: Epirubicin<br> <br> Drug: Cyclophosphamide<br> <br> Drug: 5-fluoruracil<br> <br> * Other names: 5-FU;|
| Experimental: Continue the neoadjuvant regimen<br>Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. | Drug: Paclitaxel<br> <br> * Other names: Taxol;Drug: Cisplatin<br> <br> |
| Experimental: Pathological complete response group with chemotherapy<br>Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. | Drug: Paclitaxel<br> <br> * Other names: Taxol;Drug: Cisplatin<br> <br> |
| No Intervention: Pathological complete response group with no chemotherapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | Up to 5 years | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 4 months during adjuvant therapy | 
| regional recurrence free survival (RRFS) |  | 5 years | 
| local recurrence free survival (LRFS) |  | 5 years | 
| distant-disease- free survival (DDFS) |  | 5 years |