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

October 13, 2020 updated by: Austrian Breast & Colorectal Cancer Study Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

429

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (pre- + postoperative chemotherapy)
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.
Drug: Cyclophosphamide
Cyclophosphamide 600mg/m2
Drug: Methotrexate
Methotrexate 40mg/m2
Drug: Fluorouracil
Fluorouracil 600mg/m2
Drug: Epirubicin
Epirubucin 60mg/m2 (only node-positive patients)
Other: Surgery
Surgery
Experimental: B (conventional postoperative chemotherapy)
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.
Drug: Cyclophosphamide
Cyclophosphamide 600mg/m2
Drug: Methotrexate
Methotrexate 40mg/m2
Drug: Fluorouracil
Fluorouracil 600mg/m2
Drug: Epirubicin
Epirubucin 60mg/m2 (only node-positive patients)
Other: Surgery
Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Recurrence-free survival

Secondary Outcome Measures

Outcome Measure
Rate of breast-conserving procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 1991

Primary Completion (Actual)

September 1, 2000

Study Completion (Actual)

September 1, 2000

Study Registration Dates

First Submitted

March 31, 2006

First Submitted That Met QC Criteria

March 31, 2006

First Posted (Estimate)

April 3, 2006

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCSG-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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