Randomized Study Comparing CMF and Goserelin + Tamoxifen... | NCT00309478

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

NCT00309478

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Status

Completed

Last Update Posted

Jun 29, 2023Actual

Enrollment

1,099Actual

Phase

Phase 3

Conditions

Early-stage Breast Cancer

Interventions

Cyclophosphamide
Methotrexate
Fluorouracil implant
Goserelin
Tamoxifen

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1990Actual

Primary Completion Date

Jun 2004Actual

Completion Date

Jun 2004Actual

First Submitted Date

Mar 31, 2006

First Submission Date that Met QC Criteria

Mar 31, 2006

First Posted Date

Apr 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2023

Last Update Posted Date

Jun 29, 2023Actual

Name	Class
AstraZeneca	INDUSTRY

Description Module

Brief 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 cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,099Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2 (CMF scheme)	Experimental	6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)	Drug: Cyclophosphamide Drug: Methotrexate Drug: Fluorouracil implant
1 (Nol + Zol)	Experimental	Zoladex (3 years) combined with Nolvadex (5 years)	Drug: Goserelin Drug: Tamoxifen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclophosphamide	Drug	Cyclophosphamide 600mg/m2	2 (CMF scheme)
Methotrexate

Measure	Description	Time Frame
Toxicities

Eligibility Module

Eligibility Criteria

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
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Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raimund Jakesz, MD	Austrian Breast & Colorectal Cancer Study Group	Principal Investigator

Locations

Not provided

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003520	Cyclophosphamide
D008727	Methotrexate
D005472	Fluorouracil
D017273	Goserelin
D013629	Tamoxifen

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided