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

A

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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