Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors
NCT ID: NCT01196936
Last Updated: 2026-01-05
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2010-09-30
2028-12-11
Brief Summary
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This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.
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Detailed Description
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I. To determine the impact of a two-year course of low-dose tamoxifen (tamoxifen citrate) administered at 5 mg per day on surrogate endpoint biomarkers of breast cancer (BC) risk, including: mammographic breast density (MBD), an established radiographic biomarker of BC risk; cytomorphology and proliferative index, tissue biomarkers closely linked to BC risk; and sex steroid hormones and insulin growth factors, circulating biomarkers of BC risk.
II. To establish safety and tolerability of this low-dose tamoxifen regimen, assessing both objective measures (lipid profiles, clotting factors and bone metabolism markers) and patient-reported outcomes.
III. To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year low dose tamoxifen intervention.
IV. To explore the relationship between this low-dose tamoxifen regimen and clinical measures of efficacy (new breast cancer and ductal carcinoma in situ \[DCIS\] diagnoses) and toxicity (thromboembolic events, reports of hot flashes and gynecological symptoms, liver function abnormalities, and other cancer diagnoses).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tamoxifen citrate orally (PO) once daily for 24 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO once daily for 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 10 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Arm I (tamoxifen citrate)
Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity.
Tamoxifen Citrate
5 mg PO Daily
Digital mammography
Correlative studies
immunohistochemistry staining method
Correlative Studies
pharmacological study
Correlative Studies
laboratory biomarker analysis
Correlative Studies
protein expression analysis
correlative studies
pharmacogenomic studies
correlative studies
questionnaire administration
Ancillary studies
Fine needle aspiration
Quality of Life Assessment
Ancillary Studies
Arm II (placebo)
Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity.
Placebo
1 tablet daily
Digital mammography
Correlative studies
immunohistochemistry staining method
Correlative Studies
pharmacological study
Correlative Studies
laboratory biomarker analysis
Correlative Studies
protein expression analysis
correlative studies
pharmacogenomic studies
correlative studies
questionnaire administration
Ancillary studies
Fine needle aspiration
Quality of Life Assessment
Ancillary Studies
Interventions
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Tamoxifen Citrate
5 mg PO Daily
Placebo
1 tablet daily
Digital mammography
Correlative studies
immunohistochemistry staining method
Correlative Studies
pharmacological study
Correlative Studies
laboratory biomarker analysis
Correlative Studies
protein expression analysis
correlative studies
pharmacogenomic studies
correlative studies
questionnaire administration
Ancillary studies
Fine needle aspiration
Quality of Life Assessment
Ancillary Studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No evidence of active disease from their primary cancer for at least 2 continuous years prior to registration; the indication for RT is not specified but cannot be for primary breast cancer; common examples include, but are not limited to: lymphoma, leukemia, sarcoma, and Wilms tumor occurring in pediatric patients, and lymphoma, leukemia, and sarcoma occurring in young adults; primary cancer therapy must have been completed at least 6 months prior to registration
* Well-defined menopausal status falling into one of the following categories:
* Premenopausal, defined as age at registration 45 years old or younger with regular monthly period for at least 6 consecutive months prior to registration
* Postmenopausal, defined as continuous absence of menstruation for 12 months OR status-post bilateral oophorectomy OR follicle stimulating hormone (FSH) level in the postmenopausal range
Exclusion Criteria
* Non-melanoma cancers of the skin
* Thyroid cancer
* Cervical cancer confined to the cervix or cervical intraepithelial neoplasia (CIN)
* Ductal carcinoma in situ (DCIS) or breast intraepithelial neoplasia (IEN) (includes atypical hyperplasia and lobular carcinoma in situ \[LCIS\]), or
* Superficial or non-invasive transitional cell carcinoma of the bladder
* For women with a prior history of DCIS or breast IEN, only one breast could have been involved and all therapy must have been completed at least 6 months prior to registration; in addition women with a prior history of invasive breast cancer may also be eligible, as long as only one breast was involved, they were diagnosed at least 2 years prior to study entry, and therapy was completed at least 6 months prior to study entry
* Bilateral breast implants or status-post bilateral prophylactic mastectomy
* Evidence of malignant breast disease on any form of breast imaging; the study only requires annual mammography; however, annual breast magnetic resonance imaging (MRI) is considered standard of care in this patient population (per Children's Oncology Group \[COG\] or National Comprehensive Cancer Network \[NCCN\] follow-up guidelines), and breast ultrasound may be indicated if a palpable lesion is detected on screening clinical breast exam; abnormal imaging may require additional radiographs and/or breast biopsy; patients who are found to have benign breast disease with or without atypia may continue on study as long as there is no evidence of malignancy; if there is evidence of malignancy, and only one breast is involved, they may be reapproached 6 months after completion of therapy for consideration of the trial
* Baseline categorical mammographic density scored as BIRAD 1, or extremely fatty, in both breasts; if the patient has a prior history of IEN (DCIS, LCIS, or atypical hyperplasia), the contralateral breast must not have a mammographic density score of BIRAD 1; this determination will be made at the local site
* Current or recent use (within 6 months of registration or baseline mammogram, whichever is first) of any of the following: systemic hormone replacement therapy (includes oral or transdermal formulations); Vagifem and Estring, two formulations of locally applied vaginal estrogen associated with minimal systemic absorption, may be allowed; other estrogen-containing vaginal creams, while not an exclusion, should be avoided whenever possible; patients with a history of hormone modifying herbal supplements are eligible, but patients will be asked to avoid their use after on study
* Current or recent use (within 6 months of registration or baseline mammogram, whichever is first) of any of the following: hormonal forms of contraception (includes oral, transdermal, implanted, and injectable formulations): selective estrogen receptor modifiers; aromatase inhibitors; GnRH analogs; androgens or antiandrogens
* Concurrent use of warfarin and strong inhibitors or CYP2D6 will not be allowed
* A personal history or a strong family of thromboembolism, including deep venous thrombosis (DVT), pulmonary embolus (PE), or cerebrovascular accident (CVA); a personal history of transient ischemic attack (TIA) or retinal vein thrombosis will also not be allowed; in addition, patients with a condition known to increase hypercoagulability, such as Factor V Leiden disease, will be excluded; patients with atrial fibrillation will be excluded, due to risk of CVA, but patients with coronary artery disease or congestive heart failure without atrial fibrillation will be allowed to participate
* Current intrauterine pregnancy or plans to become pregnant within two years; in addition, currently nursing mothers will be excluded
* Serum creatinine \> 2X the institutional norm
* Total bilirubin \> 2X the institutional norm
* Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \> 2X the institutional norm
* Unable to provide consent
25 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER
University Health Network, Toronto
OTHER
University of Michigan
OTHER
Dana-Farber Cancer Institute
OTHER
Mayo Clinic
OTHER
University of Washington
OTHER
City of Hope National Medical Center
OTHER
M.D. Anderson Cancer Center
OTHER
University of Chicago
OTHER
University of Minnesota
OTHER
University of Colorado, Denver
OTHER
Wake Forest University
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Smitia Bhatia
Principal Investigator
Principal Investigators
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Smita Bhatia, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope Medical Center
Duarte, California, United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
University of Chicago
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Wake Forest University
Winston-Salem, North Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
MD Anderson
Houston, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University Health Network, Toronto
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2010-01976
Identifier Type: REGISTRY
Identifier Source: secondary_id
08218
Identifier Type: -
Identifier Source: org_study_id
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