Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients

June 28, 2023 updated by: Austrian Breast & Colorectal Cancer Study Group

A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-positive, Lymph Node-positive or -Negative Patients

Primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free survival, overall survival) in premenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1099

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Premenopausal patients with histologically verified, lymph node-negative (pT1c-pT3) or lymph node-positive (pT1a-pT3) breast cancer
  • Hormone receptor-positive status
  • More than 6 histologically examined lymph nodes

  • Laboratory parameters

    1. hematopoiesis: > 3500/µl leukocytes, > 100,000/µl thrombocytes
    2. renal function: creatinin < 1.5mg %
    3. hepatic function: GOT </= 2.5 x UNL
    4. bilirubin: < 1.5mg %
    5. metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
    6. blood coagulation: PZ > 60%
  • Concluded healing process following surgery
  • </= 4 weeks interval since surgery
  • Informed consent

Exclusion Criteria:

  • T4 carcinoma; inflammatory breast cancer, carcinoma in situ
  • Simultaneous or sequential bilateral breast cancer
  • Preoperative tumor-reducing radiotherapy or preoperative tumor-specific medical treatment
  • Male patients
  • Pregnancy or lactation
  • Lacking compliance or understanding of the disease
  • General contraindication against cytostatic treatment
  • Serious concomitant disease preventing implementation of adjuvant therapy or regular follow-up
  • Second carcinoma or status post second carcinoma (except for curatively 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: 2 (CMF scheme)
6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
Drug: Cyclophosphamide
Cyclophosphamide 600mg/m2
Drug: Methotrexate
Methotrexate 40mg/m2
Drug: Fluorouracil implant
Fluorouracil 600mg/m2
Experimental: 1 (Nol + Zol)
Zoladex (3 years) combined with Nolvadex (5 years)
Drug: Goserelin
Zoladex 3.6mg/28 days for 3 years
Other Names:
  • Zoladex
Drug: Tamoxifen
Nolvadex 20mg/day for 5 years
Other Names:
  • Nolvadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Disease-free survival

Secondary Outcome Measures

Outcome Measure
Toxicities

Collaborators and Investigators

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

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Raimund Jakesz, MD, 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)

December 1, 1990

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

March 31, 2006

First Submitted That Met QC Criteria

March 31, 2006

First Posted (Estimated)

April 3, 2006

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCSG-5

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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