Randomized Study Comparing Pre- and Postoperative Vs. Conventional Adjuvant Treatment in Receptor-Negative Patients

This study has been completed.
Sponsor:
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00309569
First received: March 31, 2006
Last updated: NA
Last verified: October 1999
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Early Stage Breast Cancer
Drug: Cyclophosphamide
Drug: Methotrexate
Drug: Fluorouracil
Drug: Epirubicine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Comparing Pre- and Postoperative Vs. Conventional Adjuvant Treatment Hormone Receptor-Negative Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • Overall survival
  • Recurrence-free survival

Secondary Outcome Measures:
  • Rate of breast-conserving procedures

Estimated Enrollment: 480
Study Start Date: October 1991
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with bioptically verified breast cancer
  • Estrogen receptor-negative status
  • Age: < 70 years
  • WHO Performance Status < 2
  • Laboratory parameters

    1. hematopoiesis: > 3500/l leukocytes, > 100,000/l thrombocytes
    2. renal function: creatinin < 1.5mg%
    3. hepatic function: GOT  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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00309569

Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Investigators
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00309569     History of Changes
Other Study ID Numbers: ABCSG-7
Study First Received: March 31, 2006
Last Updated: March 31, 2006
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
Cyclophosphamide
Methotrexate
Fluorouracil
Epirubicine
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Fluorouracil
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014