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Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer

NCT00301548 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2006-03-13

No results posted yet for this study

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).

Conditions

  • Breast Neoplasms
  • Carcinoma

Interventions

DRUG

perioperative chemotherapy

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Colleoni A Marco, MD · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Completion
2005-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00301548 on ClinicalTrials.gov