Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00002529




Registration number
NCT00002529
Ethics application status
Date submitted
1/11/1999
Date registered
29/07/2004
Date last updated
4/04/2013

Titles & IDs
Public title
Hormone Therapy and Chemotherapy in Treating Perimenopausal or Postmenopausal Women With Node-Positive Breast Cancer
Scientific title
Adjuvant Therapy for Post/Perimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone.
Secondary ID [1] 0 0
IBCSG-12-93
Secondary ID [2] 0 0
CDR0000078385
Universal Trial Number (UTN)
Trial acronym
12-93
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - epirubicin hydrochloride
Treatment: Drugs - tamoxifen citrate
Treatment: Drugs - toremifene

Experimental: AC with concurrent tamoxifen - AC for 4 cycles with concurrent tamoxifen for 5 years

Experimental: AC followed by tamoxifen - AC for 4 cycles followed by tamoxifen to 5 years from randomization.

Experimental: Tamoxifen alone - Tamoxifen alone for 5 years.

Experimental: AC with concurrent toremifene - AC for 4 cycles with concurrent toremifene for 5 years.

Experimental: AC followed by toremifene - AC for 4 cycles followed by toremifene to 5 years from randomization.

Experimental: Toremifene alone - Toremifene alone for 5 years.


Treatment: Drugs: cyclophosphamide
cyclophosphamide 600 mg/m2 i.v. day 1) every 21 days

Treatment: Drugs: doxorubicin hydrochloride
doxorubicin 60 mg/m2 i.v. day 1) every 21 days, intravenous.

Treatment: Drugs: epirubicin hydrochloride
epirubicin 90 mg/m2 i.v. day 1) every 21 days, intravenous.

Treatment: Drugs: tamoxifen citrate
Tamoxifen 20 mg daily.

Treatment: Drugs: toremifene
Toremifene 60 mg daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
17 years after randomization
Secondary outcome [1] 0 0
Disease-free and systemic disease-free survival.
Timepoint [1] 0 0
17 years from randomization
Secondary outcome [2] 0 0
Quality of life
Timepoint [2] 0 0
17 years from randomization
Secondary outcome [3] 0 0
Toxicity
Timepoint [3] 0 0
17 years after randomization

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Histologically proven stage T1-3, pN1, M0 carcinoma of the breast considered suitable for adjuvant treatment with endocrine therapy alone Estrogen receptor at least 10 fmol/mg cytosol protein or positive on immunohistochemical assay Potentially curative resection within 6 weeks of entry by one of the following: Total mastectomy with negative margins Breast-conserving procedure (lumpectomy or quadrantectomy) for tumors less than 5 cm Adequate re-resection or mastectomy within 4 weeks of initial surgery required if margins are positive after initial surgery Axillary clearance (not sampling) required at surgery, with at least 1 node positive upon histopathologic examination of at least 8 nodes Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan, skeletal pain of unknown cause) must be proven benign No bilateral breast cancer Any mass in contralateral breast must be proven benign by biopsy

PATIENT CHARACTERISTICS: Age: 70 and under Sex: Women only Menopausal status: Peri/postmenopausal, i.e.: More than 6 months since last normal menstrual period (LNMP) with no prior hysterectomy and no hormone replacement therapy (HRT) Prior hysterectomy and no HRT and either age greater than 55 or age 55 or less with postmenopausal LH, FSH, and E2 levels On HRT and either age 50 or greater or LNMP more than 6 months prior to starting HRT Performance status: Not specified Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hepatic: Bilirubin less than 1.1 mg/dL (20 micromoles/L) AST less than 60 IU/L Renal: Creatinine less than 1.3 mg/dL (120 micromoles/L) Other: No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up No psychiatric or addictive disorder that would preclude informed consent No prior or concurrent second malignancy except: Nonmelanomatous skin cancer Adequately treated in situ carcinoma of the cervix Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY: No prior therapy for breast cancer other than potentially curative surgery (see Disease Characteristics)
Minimum age
No limit
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/1993
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
452
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Newcastle Mater Misericordiae Hospital - Newcastle
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital, Sydney - Sydney
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Anti-Cancer Council of Victoria, Melbourne - Carlton South
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital, Perth - Perth
Recruitment postcode(s) [1] 0 0
NSW 2310 - Newcastle
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3053 - Carlton South
Recruitment postcode(s) [5] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Aviano
Country [2] 0 0
Italy
State/province [2] 0 0
Brescia
Country [3] 0 0
Italy
State/province [3] 0 0
Milano
Country [4] 0 0
Italy
State/province [4] 0 0
Rimini
Country [5] 0 0
Italy
State/province [5] 0 0
Rome
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Slovenia
State/province [7] 0 0
Ljubljana
Country [8] 0 0
South Africa
State/province [8] 0 0
Cape Town
Country [9] 0 0
Sweden
State/province [9] 0 0
Gothenburg (Goteborg)
Country [10] 0 0
Switzerland
State/province [10] 0 0
Basel
Country [11] 0 0
Switzerland
State/province [11] 0 0
Bern
Country [12] 0 0
Switzerland
State/province [12] 0 0
Lausanne
Country [13] 0 0
Switzerland
State/province [13] 0 0
Neuchatel
Country [14] 0 0
Switzerland
State/province [14] 0 0
Saint Gallen
Country [15] 0 0
Switzerland
State/province [15] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Other
Name
ETOP IBCSG Partners Foundation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edda Simoncini, MD
Address 0 0
Spedali Civili di Brescia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00002529