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Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer

Phase 2
18 Years
70 Years
Not Enrolling
Breast Neoplasms, Carcinoma

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Trial Information

Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer

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

- 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

- History of second malignancy (exception in situ carcinoma of the uterine cervix and
basal or squamous cell carcinoma of the skin)

Type of Study:


Study Design:

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

Outcome Measure:

Reduction in Ki-67 labeling index

Principal Investigator

Colleoni A Marco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

European Institute of Oncology


Italy: Ministry of Health

Study ID:

IEO S31/499



Start Date:

February 2000

Completion Date:

June 2005

Related Keywords:

  • Breast Neoplasms
  • Carcinoma
  • antineoplastic protocols
  • neoadjuvant therapy
  • perioperative chemotherapy
  • fluorouracil
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma