Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT00301548
First received: March 9, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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
Breast Neoplasms
Carcinoma
Drug: perioperative chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer

Resource links provided by NLM:


Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:
  • Reduction in Ki-67 labeling index

Secondary Outcome Measures:
  • Pathological complete remission rate
  • Disease-free survival
  • Toxicity and safety

Estimated Enrollment: 172
Study Start Date: February 2000
Estimated Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00301548

Sponsors and Collaborators
European Institute of Oncology
Investigators
Principal Investigator: Colleoni A Marco, MD European Institute of Oncology
  More Information