Clinical trial · Interventional
Tamoxifen in Preventing Breast Cancer in Women at Increased Risk for Breast Cancer
An Exploratory Study to Identify Potential Surrogate Endpoint Biomarkers That Are Modulated by Tamoxifen vs. Placebo in Women With an Increased Risk for Breast Cancer
NCT00096369CI-TRIAL-00036722terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): accrual goal not met
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of tamoxifen may be effective in preventing breast cancer. PURPOSE: This randomized phase II trial is studying tamoxifen to see how well it works compared to placebo in preventing breast cancer in women who are at increased risk for the disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Plasma levels of hormones and binding proteins as measured by ELISA, IHC, and TUNEL at baseline and 3 months
- measure
- Markers of proliferation and apoptosis in breast cells as measured by quantitative MSP at baseline and 3 months
- measure
- Promoter-region methylation as assessed by microarrays at baseline and 3 months
- measure
- Gene expression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* At increased risk for breast cancer, as defined by 1 of the following criteria:
* Histologically confirmed lobular carcinoma in situ (LCIS) treated by local excision only
* Composite increased breast cancer risk of ≥ 1.67% over 5 years, based on the following criteria:
* Age
* Number of first-degree female relatives with breast cancer
* One or more prior breast biopsies
* Fine-needle aspiration cytology of a non-cystic lesion in lieu of an open biopsy is considered a biopsy
* Prior diagnosis of atypical hyperplasia of the breast
* Age at first live birth
* Nulliparity
* Race
* Age at onset of menarche
* No prior or suspected invasive breast cancer or ductal carcinoma in situ
* No clinical evidence of malignancy by physical examination, including a breast examination within the past 3 months
* No evidence of suspicious or malignant disease or uncharacterized lesions on bilateral mammogram within the past 6 months
* Normal gynecologic examination, including a bimanual pelvic examination and, if indicated, pap smear within the past 12 months
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 35 and over
Sex
* Female
Menopausal status
* Premenopausal and ovulating\*, defined as having regular menses for the past 6 months OR irregular menses with follicular phase (i.e., day 3) follicle-stimulating hormone level \< 20 mIU/mL OR
* Postmenopausal NOTE: \* Ovulation is determined by day 21 progesterone level \> 3 ng/mL
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Complete blood count normal
* No active bleeding disorder (e.g., qualitative or quantitative platelet abnormality, hemophilia, or von Willebrand's disease)
Hepatic
* Liver function tests normal
Renal
* Not specified
Cardiovascular
* No prior deep-vein thrombosis except a single occurrence related to lower extremity trauma
* No prior cerebral vascular accident
* No prior transient ischemic attack
Pulmonary
* No prior pulmonary embolus except a single occurrence related to lower extremity trauma
Other
* No saline or silicone breast implants
* No known allergy to tamoxifen
* No macular degeneration
* No malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No nonmalignant disease that would preclude administration of tamoxifen
* No psychiatric condition, including a history of clinical depression or addictive disorder, that would preclude giving informed consent or study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective nonhormonal contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior systemic adjuvant chemotherapy for LCIS
Endocrine therapy
* No prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators
* At least 3 months since prior and no concurrent use of any of the following drugs:
* Estrogen or progesterone replacement therapy
* Oral contraceptives
* Androgens
* Luteinizing hormone-releasing hormone analogs
* Prolactin inhibitors
* Antiandrogens
* Steroids
* No concurrent steroids for asthma
Radiotherapy
* No prior radiotherapy for LCIS
Surgery
* No prior bilateral prophylactic mastectomy
* No prior mastectomy for LCIS
Other
* Concurrent nonhormonal medications allowed
* No concurrent warfarin or cholestyramine
* No prior or concurrent participation in any other cancer prevention study
* Patients treated with placebo on protocol NSABP-P-1 are eligibleReferences
Publications (0)
Data not yet available
No reference posted for this study.