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Early-stage Breast CancerPhase 3NCT00309478

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

A Phase 3 study testing Cyclophosphamide, Methotrexate and Fluorouracil implant in people with Early-stage Breast Cancer, run by Austrian Breast & Colorectal Cancer Study Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Early-stage Breast Cancer
What is being tested?
Cyclophosphamide, Methotrexate and Fluorouracil implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,099 participants
Where
No sites listed yet
Study dates
Dec 1990to Jun 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
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  • 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)

About this study

Official title: 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.

Being tested
Cyclophosphamide, Methotrexate, Fluorouracil implant, Goserelin, Tamoxifen
Keywords
Cyclophosphamide, Methotrexate, Fluorouracil, Goserelin, Tamoxifen, Breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    Cyclophosphamide 600mg/m2

  • MethotrexateDrug

    Methotrexate 40mg/m2

  • Fluorouracil implantDrug

    Fluorouracil 600mg/m2

  • GoserelinDrug

    Also called Zoladex

    Zoladex 3.6mg/28 days for 3 years

  • TamoxifenDrug

    Also called Nolvadex

    Nolvadex 20mg/day for 5 years

Study groups in NCT00309478
Study groupRoleWhat they receive
2 (CMF scheme)Experimental6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
Receives: Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Fluorouracil implant
1 (Nol + Zol)ExperimentalZoladex (3 years) combined with Nolvadex (5 years)
Receives: Drug: Goserelin; Drug: Tamoxifen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

  2. Overall survival

Secondary outcomes (1)

  1. Toxicities

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2006 (estimated)
  2. Study startDec 1990
  3. Primary completionJun 2004
  4. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,099 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00309478
Sponsor's protocol ID
ABCSG-5
Status last verified
Jun 2023
First submitted
31 Mar 2006
Last updated
29 Jun 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide, Methotrexate and Fluorouracil implant in people with Early-stage Breast Cancer, run by Austrian Breast & Colorectal Cancer Study Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00309478.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

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