Status:
COMPLETED
Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer
Lead Sponsor:
European Institute of Oncology
Conditions:
Breast Neoplasms
Carcinoma
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00301548
Start Date
February 1 2000
End Date
June 1 2005
Last Update
March 13 2006
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