Breast Neoplasms, Carcinoma
Conditions
Keywords
antineoplastic protocols, neoadjuvant therapy, perioperative chemotherapy, fluorouracil
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).
Interventions
Sponsors
European Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Ki-67 labeling index | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate | — |
| Disease-free survival | — |
| Toxicity and safety | — |
Outcome results
None listed