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Sponsored by: |
European Institute of Oncology |
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Information provided by: | European Institute of Oncology |
ClinicalTrials.gov Identifier: | NCT00301548 |
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).
Condition | Intervention | Phase |
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Breast Neoplasms Carcinoma |
Drug: perioperative chemotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | IEO S31/499 |
Study First Received: | March 9, 2006 |
Last Updated: | March 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00301548 |
Health Authority: | Italy: Ministry of Health |
antineoplastic protocols neoadjuvant therapy perioperative chemotherapy fluorouracil |
Skin Diseases Fluorouracil Breast Neoplasms |
Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site |