Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study |
- Overall survival (i.e., all-cause mortality) [ Designated as safety issue: No ]
- Specific-cause mortality [ Designated as safety issue: No ]
- Incidence of second primary tumors [ Designated as safety issue: No ]
| Estimated Enrollment: | 20000 |
| Study Start Date: | October 1995 |
OBJECTIVES:
- Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen.
OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.
Patients are followed annually.
PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Curatively treated carcinoma of the breast
Currently taking adjuvant tamoxifen
- Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen)
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- No contraindications to receiving tamoxifen
- No other serious medical problems
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior biologic therapy allowed
Chemotherapy:
- Prior chemotherapy allowed
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- Prior radiotherapy allowed
Surgery:
- Prior surgery allowed
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003016 History of Changes |
| Other Study ID Numbers: | CDR0000065596, ATLAS, EU-96064 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Tamoxifen Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013