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

Austrian Breast & Colorectal Cancer Study Group

Status and phase: Completed; Phase 3

Conditions: Early Stage Breast Cancer

Treatments: Other: Surgery; Drug: Fluorouracil; Drug: Methotrexate; Drug: Epirubicin; Drug: Cyclophosphamide

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00309569

ABCSG-7

Details and patient eligibility

About

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.

Enrollment: 429 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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429 participants in 2 patient groups

A (pre- + postoperative chemotherapy)

Experimental group

Description:

3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.

Treatment:

Drug: Cyclophosphamide

Drug: Epirubicin

Other: Surgery

Drug: Fluorouracil

Drug: Methotrexate

B (conventional postoperative chemotherapy)

Experimental group

Description:

Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.

Treatment:

Drug: Cyclophosphamide

Drug: Epirubicin

Other: Surgery

Drug: Fluorouracil

Drug: Methotrexate