Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients

A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients

Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.

Inclusion Criteria:

• Patients with bioptically verified breast cancer

• Estrogen receptor-negative status

• Age: < 70 years

• WHO Performance Status < 2

• Laboratory parameters

  1. hematopoiesis: > 3500/mm3 leukocytes, > 100,000/mm3 thrombocytes
  2. renal function: creatinin < 1.5mg%
  3. hepatic function: GOT max. 2.5 x UNL
  4. bilirubin: < 2.0 mg %
  5. metabolic parameters: Na, Ca, K in normal range

• </= 4 weeks interval since surgery

• Informed consent

Exclusion Criteria:

• Patients with locally inoperable cancer, M1
• Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment
• Pregnancy or lactation
• General contraindication against cytostatic treatment
• T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer
• Lacking compliance or understanding of disease
• Serious concomitant disease
• Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)