Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer

Study Overview
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Brief Summary
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The role of early timing of adjuvant chemotherapy was postulated to be particularly important for patients with endocrine non-responsive disease. The role of cytotoxicity during the period of breast surgery itself and immediately after (perioperative chemotherapy) remained unknown. We investigated in a randomized trial the role of perioperative chemotherapy in patients treated with a preoperative chemotherapy for locally advanced breast cancer and compare it to the preoperative chemotherapy without additional cytotoxic therapy during and immediately after definitive surgery. Patients with T2-3 N0-2 M0 breast cancer, with both estrogen receptors (ER) and progesterone receptors (PgR) expressed in less than 20% of tumor cells, or with absence of progesterone receptors, received up to 6 courses of primary systemic therapy with epirubicin 25 mg/m2 intravenously (i.v.) on days 1 and 2, cisplatin 60 mg/m2 i.v. on day 1, and 5-fluorouracil 200 mg/m2 i.v. daily as continuous infusion (ECF). Patients achieving a partial or complete remission were randomized to continue the infusion of fluorouracil until 2 weeks after surgery (perioperative treatment arm) or to stop fluorouracil infusion one week before surgery, on day 21 of the sixth cycle (control arm).

Official Title
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Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer

Conditions
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Breast Neoplasms, Carcinoma

Intervention / Treatment
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* Drug: perioperative chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with breast cancer histologically proven > 2 cm, ER and PgR <20% or Any ER and PgR absent (T2,T3 N0-2, M0) No treatment with previous chemotherapy/hormonotherapy Performance status 0-2 (ECOG scale, Appendix 2) Measurable or evaluable lesions Age between 18-70 years No significant intercurrent illness such as diabetes, cardiovascular, renal or neurologic impairments Absence of psychiatric illness WBC > 4,000/mm3; PLTS > 100,000/mm3 AST, ALT, LDH, gamma-GT < 2.5 x upper limit of normal and bilirubin < 3 mg/100 ml Informed consent obtained Pregnancy test (in fertile women). An effective contraceptive method must be utilized by fertile women. Baseline examinations (chest X ray, CT scan, ECG etc) performed within one month prior initiation to therapy Exclusion Criteria: Uncontrolled infection and metabolite disease Distant metastases Active peripheric and/or central neurological disease Active cardiac disease defined as CHF (NYHA III-IV) significant arrhytmias, bilateral bundle branch block or recent (less than 3 months) history of myocardial infarction History of second malignancy (exception in situ carcinoma of the uterine cervix and basal or squamous cell carcinoma of the skin)

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

| Intervention/Treatment |
| --- |
|Drug: perioperative chemotherapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Ki-67 labeling index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete remission rate |  |  | 
| Disease-free survival |  |  | 
| Toxicity and safety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antineoplastic protocols, neoadjuvant therapy, perioperative chemotherapy, fluorouracil