Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer
Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
Participant gender:
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).