Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer

NCT ID: NCT00301548

Last Updated: 2006-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29
• Study Completion Date: 2005-06-30

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).

Conditions

Breast Neoplasms; Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

perioperative chemotherapy

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Principal Investigators

Colleoni A Marco, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

References

Clahsen PC, van de Velde CJ, Goldhirsch A, Rossbach J, Sertoli MR, Bijnens L, Sylvester RJ. Overview of randomized perioperative polychemotherapy trials in women with early-stage breast cancer. J Clin Oncol. 1997 Jul;15(7):2526-35. doi: 10.1200/JCO.1997.15.7.2526.

Reference Type: BACKGROUND

PMID: 9215821 (View on PubMed)

Colleoni M, Gelber S, Coates AS, Castiglione-Gertsch M, Gelber RD, Price K, Rudenstam CM, Lindtner J, Collins J, Thurlimann B, Holmberg SB, Cortes-Funes H, Simoncini E, Murray E, Fey M, Goldhirsch A; International Breast Cancer Study Group. Influence of endocrine-related factors on response to perioperative chemotherapy for patients with node-negative breast cancer. J Clin Oncol. 2001 Nov 1;19(21):4141-9. doi: 10.1200/JCO.2001.19.21.4141.

Reference Type: BACKGROUND

PMID: 11689582 (View on PubMed)

Ludwig Breast Cancer Study Group. Prolonged disease-free survival after one course of perioperative adjuvant chemotherapy for node-negative breast cancer. N Engl J Med. 1989 Feb 23;320(8):491-6. doi: 10.1056/NEJM198902233200804.

Reference Type: BACKGROUND

PMID: 2644533 (View on PubMed)

Other Identifiers

IEO S31/499

Identifier Type: -

Identifier Source: org_study_id