Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer
- Conditions
- Breast NeoplasmsCarcinoma
- Registration Number
- NCT00301548
- Lead Sponsor
- European Institute of Oncology
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 172
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction in Ki-67 labeling index
- Secondary Outcome Measures
Name Time Method Pathological complete remission rate Disease-free survival Toxicity and safety