Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer

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).

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Key information

Conditions

Breast Neoplasms Breast Diseases Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

perioperative chemotherapy

Drug

Primary outcomes

Reduction in Ki-67 labeling index

Secondary outcomes

Pathological complete remission rate
Disease-free survival
Toxicity and safety

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer

Important dates

Study start: 2000
Study completion: 2005
First posted: Mar 13, 2006
Registry last updated: Mar 13, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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