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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309569
First Posted: April 3, 2006
Last Update Posted: April 3, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
  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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00309569     History of Changes
Other Study ID Numbers: ABCSG-7
First Submitted: March 31, 2006
First Posted: April 3, 2006
Last Update Posted: April 3, 2006
Last Verified: October 1999

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

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