Breast CancerPhase 3NCT00003678
Tamoxifen in Treating Women With Breast Cancer
A Phase 3 study testing tamoxifen citrate and adjuvant therapy in people with Breast Cancer, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- tamoxifen citrate and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 1991to not given
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cancer Research UK Clinical Trials Unit - Birmingham
Birmingham, England, B15 2TT
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- tamoxifen citrate, adjuvant therapy
- Keywords
- stage I breast cancer, stage II 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.
tamoxifen citrateDrug
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Secondary outcomes (2)
Disease recurrence
Death due to breast cancer, other primary tumors, or cardiovascular causes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Rea, MD, Study chair, University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003678
- Sponsor's protocol ID
- CDR0000066779
- Other IDs
- CRC-TU-ATTOM, EU-98042, ISRCTN17222211
- Status last verified
- Mar 2007
- First submitted
- 1 Nov 1999
- Last updated
- 19 Dec 2013
- Results posted
- No
Publications
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.
PubMed 10907940Rea 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.
PubMed 9582148Earl 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.
PubMed 9269542Earl 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.
PubMed 8616358Gray 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.
PubMed 8350355Poterala 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.
PubMed 35213039Bartlett 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.
PubMed 31504126
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00003678
- Acronym / sponsor ID
- CDR0000066779
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Study start
- May 1991
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamoxifen citrate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
All-cause mortality
2 secondary outcomes
Disease recurrence
Death due to breast cancer, other primary tumors, or cardiovascular causes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Background: PubMed 10907940Gray 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.
- Background: PubMed 9582148Rea 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.
- Background: PubMed 9269542Earl 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.
- Background: PubMed 8616358Earl 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.
- Background: PubMed 8350355Gray 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.
- Derived from this study: PubMed 35213039Poterala 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.
- Derived from this study: PubMed 31504126Bartlett 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Rea, MD study chair
University Hospital Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tamoxifen citrate and adjuvant therapy in people with Breast Cancer, run by University Hospital Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
All-cause mortality. 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 NCT00003678, which also lists 7 linked publications.
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 19 Dec 2013.