Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301548
• Other study ID #: IEO S31/499
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2006
• Last updated: March 9, 2006
• Start date: February 2000
• Est. completion date: June 2005

Study information

• Verified date: January 2006
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma

Intervention

Drug:
• perioperative chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

References & Publications (3)

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. — View Citation

Colleoni M, Gelber S, Coates AS, Castiglione-Gertsch M, Gelber RD, Price K, Rudenstam CM, Lindtner J, Collins J, Thürlimann 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Ki-67 labeling index
Secondary	Pathological complete remission rate
Secondary	Disease-free survival
Secondary	Toxicity and safety