Back to resultsTamoxifen in Treating Women With Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
tamoxifen citrate
adjuvant therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed breast carcinoma that has been completely excised Clinically relapse free Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND have no clear indication for or against receiving further tamoxifen No significant endometrial hyperplasia No patients with negligibly low risk of breast cancer death Hormone receptor status: Any status allowed PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Any status allowed Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other life threatening disease No retinopathy No psychiatric disorder or other condition that would preclude study compliance No serious toxicity (e.g., depression) thought to be due to tamoxifen Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: See Disease Characteristics Other: Any primary treatment allowed
Sites / Locations
- Cancer Research UK Clinical Trials Unit - Birmingham
Outcomes
Primary Outcome Measures
All-cause mortality
Secondary Outcome Measures
Disease recurrence
Death due to breast cancer, other primary tumors, or cardiovascular causes
Full Information
NCT ID
NCT00003678
First Posted
November 1, 1999
Last Updated
December 18, 2013
Sponsor
University Hospital Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00003678
Brief Title
Tamoxifen in Treating Women With Breast Cancer
Official Title
A Large, Uniquely Simple, Randomised Study to Assess Much More Reliably the Balance of Benefits and Risks of Prolonging Adjuvant Tamoxifen Treatment in Early Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Birmingham
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.
Detailed Description
OBJECTIVES:
Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years.
OUTLINE: This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients discontinue tamoxifen after at least 2 years of prior treatment.
Arm II: Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression.
Patients are followed annually.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 8,000-20,000 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage I breast cancer, stage II breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
All-cause mortality
Secondary Outcome Measure Information:
Title
Disease recurrence
Title
Death due to breast cancer, other primary tumors, or cardiovascular causes
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed breast carcinoma that has been completely excised
Clinically relapse free
Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND have no clear indication for or against receiving further tamoxifen
No significant endometrial hyperplasia
No patients with negligibly low risk of breast cancer death
Hormone receptor status:
Any status allowed
PATIENT CHARACTERISTICS:
Age:
Not specified
Sex:
Female
Menopausal status:
Any status allowed
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Not specified
Renal:
Not specified
Other:
No other life threatening disease
No retinopathy
No psychiatric disorder or other condition that would preclude study compliance
No serious toxicity (e.g., depression) thought to be due to tamoxifen
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
Not specified
Endocrine therapy:
See Disease Characteristics
Radiotherapy:
Not specified
Surgery:
See Disease Characteristics
Other:
Any primary treatment allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Rea, MD
Organizational Affiliation
University Hospital Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Research UK Clinical Trials Unit - Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
10907940
Citation
Gray R, Davies C, Perry P. Tamoxifen for early breast cancer: better late than never. Ann Oncol. 2000 May;11(5):505-7. doi: 10.1023/a:1008323116265. No abstract available.
Results Reference
background
PubMed Identifier
9582148
Citation
Rea D, Poole C, Gray R. Adjuvant tamoxifen: how long before we know how long? BMJ. 1998 May 16;316(7143):1518-9. doi: 10.1136/bmj.316.7143.1518. No abstract available.
Results Reference
background
PubMed Identifier
9269542
Citation
Earl H, Gray R, Kerr D, Lee M. The optimal duration of adjuvant tamoxifen treatment for breast cancer remains uncertain: randomize into aTTom. Clin Oncol (R Coll Radiol). 1997;9(3):141-3. doi: 10.1016/s0936-6555(97)80067-2. No abstract available.
Results Reference
background
PubMed Identifier
8616358
Citation
Earl H, Baker P, Kerr D, Lee M, Gray R, Baum M. Adjuvant treatment with tamoxifen. Recruitment into studies assessing optimum duration of treatment must continue. BMJ. 1996 Apr 20;312(7037):1036-7. doi: 10.1136/bmj.312.7037.1036b. No abstract available.
Results Reference
background
PubMed Identifier
8350355
Citation
Gray R. Tamoxifen: how boldly to go where no women have gone before. J Natl Cancer Inst. 1993 Sep 1;85(17):1358-60. doi: 10.1093/jnci/85.17.1358. No abstract available.
Results Reference
background
PubMed Identifier
35213039
Citation
Poterala JE, Wisinski KB. Abbreviated endocrine therapy duration for low estrogen receptor-positive breast cancer: The counter to extended endocrine therapy. Cancer. 2022 May 1;128(9):1724-1726. doi: 10.1002/cncr.34158. Epub 2022 Feb 25. No abstract available.
Results Reference
derived
PubMed Identifier
31504126
Citation
Bartlett JMS, Sgroi DC, Treuner K, Zhang Y, Ahmed I, Piper T, Salunga R, Brachtel EF, Pirrie SJ, Schnabel CA, Rea DW. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen-To Offer More? (aTTom) trial. Ann Oncol. 2019 Nov 1;30(11):1776-1783. doi: 10.1093/annonc/mdz289.
Results Reference
derived
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Tamoxifen in Treating Women With Breast Cancer
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