Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients

Study Overview
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Brief Summary
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Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.

Official Title
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A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients

Conditions
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Early Stage Breast Cancer

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Methotrexate
* Drug: Fluorouracil
* Drug: Epirubicin
* Other: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with bioptically verified breast cancer Estrogen receptor-negative status Age: < 70 years WHO Performance Status < 2 Laboratory parameters hematopoiesis: > 3500/mm3 leukocytes, > 100,000/mm3 thrombocytes renal function: creatinin < 1.5mg% hepatic function: GOT max. 2.5 x UNL bilirubin: < 2.0 mg % metabolic parameters: Na, Ca, K in normal range </= 4 weeks interval since surgery Informed consent Exclusion Criteria: Patients with locally inoperable cancer, M1 Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment Pregnancy or lactation General contraindication against cytostatic treatment T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer Lacking compliance or understanding of disease Serious concomitant disease Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 (pre- + postoperative chemotherapy)<br>3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF. | Drug: Cyclophosphamide<br>* Cyclophosphamide 600mg/m2<br>Drug: Methotrexate<br>* Methotrexate 40mg/m2<br>Drug: Fluorouracil<br>* Fluorouracil 600mg/m2<br>Drug: Epirubicin<br>* Epirubucin 60mg/m2 (only node-positive patients)<br>Other: Surgery<br>* Surgery<br>|
| Experimental: B (conventional postoperative chemotherapy)<br>Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF. | Drug: Cyclophosphamide<br>* Cyclophosphamide 600mg/m2<br>Drug: Methotrexate<br>* Methotrexate 40mg/m2<br>Drug: Fluorouracil<br>* Fluorouracil 600mg/m2<br>Drug: Epirubicin<br>* Epirubucin 60mg/m2 (only node-positive patients)<br>Other: Surgery<br>* Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Recurrence-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of breast-conserving procedures |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclophosphamide, Methotrexate, Fluorouracil, Epirubicine, Breast Cancer