Breast CancerPhase 2LDTamNCT01196936
Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors
A Phase 2 study testing Tamoxifen Citrate, Digital mammography and immunohistochemistry staining method in people with Breast Cancer, run by University of Alabama at Birmingham at 13 sites in 2 countries.
Trial summary
Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen Citrate, Digital mammography and immunohistochemistry staining method
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2010to 11 Dec 2028
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exposure to radiation therapy (RT) delivered to the chest, axilla, and/or supraclavicular areas at a cumulative dose of 12 Gy or more by age 40 years; in addition, patients who received total body irradiation by age 40 may be considered
- 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
Who cannot join
- Subsequent malignant neoplasm (SMN) other than those listed below diagnosed within 2 years of study entry; patients with the listed indolent or pre-invasive neoplasms may be eligible if diagnosed within 2 years and all treatment was completed at least 6 months prior to registration:
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
University of Michigan
Ann Arbor, Michigan, 48109-5718
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
City of Hope Medical Center
Duarte, California, 91010
MD Anderson
Houston, Texas, 77030
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Minnesota
Minneapolis, Minnesota, 55455
Mayo Clinic
Rochester, Minnesota, 55905
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Low-Dose Tamoxifen for Radiation-Induced Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial
Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells
This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Breast Cancer
- Being tested
- Tamoxifen Citrate, Placebo, Digital mammography, immunohistochemistry staining method, pharmacological study
- Keywords
- Cancer survivors, Low Dose Tamoxifen, Breast Cancer Risk Reduction
- 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
Also called Marketed under trade name Nolvadex as 10 mg and 20 mg tablets, ICI 46,474
5 mg PO Daily
PlaceboDrug
1 tablet daily
Digital mammographyProcedure or surgery
Correlative studies
immunohistochemistry staining methodOther
Correlative Studies
Correlative Studies
laboratory biomarker analysisOther
Correlative Studies
protein expression analysisGenetic
correlative studies
pharmacogenomic studiesOther
correlative studies
questionnaire administrationOther
Ancillary studies
Fine needle aspirationProcedure or surgery
Also called Correlative studies
Quality of Life AssessmentOther
Ancillary Studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (tamoxifen citrate) | Experimental | Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Tamoxifen Citrate; Procedure: Digital mammography; Other: immunohistochemistry staining method; Other: pharmacological study; Other: laboratory biomarker analysis; Genetic: protein expression analysis; Other: pharmacogenomic studies; Other: questionnaire administration; Procedure: Fine needle aspiration; Other: Quality of Life Assessment |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Placebo; Procedure: Digital mammography; Other: immunohistochemistry staining method; Other: pharmacological study; Other: laboratory biomarker analysis; Genetic: protein expression analysis; Other: pharmacogenomic studies; Other: questionnaire administration; Procedure: Fine needle aspiration; Other: Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammographic Breast Density
Mammographic density was quantified as percentage of fibroglandular tissue. Using an intention-to-treat analysis, mammographic breast density (MBD) was compared between patients in the low dose tamoxifen intervention and placebo group by applying the linear mixed effects model for normally distributed data.
Measured: At year two post treatment
Secondary outcomes (8)
Insulin Growth Factor Levels (IGF1)
IGF1 will be treated as a continuous measure. The linear mixed effects model for between group comparisons of measures from 3 time points will be applied. The unstructured mean model and linear in time model will be employed.
Measured: Up to 2 years
Number of Grade 2-4 Toxicities
Will be tabulated by treatment arm. Differences by treatment arm will be evaluated using Fisher exact tests.
Measured: Up to 2 years
Biomarker Levels
Total cholesterol, low and high density lipoprotein, triglycerides, and anti-thrombin III enzymatic assay measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time.
Measured: Up to 2 years
Percentage of Pills Taken Out of the Total Prescribed
The number of pills taken out of the total prescribed in a 3-month period will be modeled as a random effects binomial regression model. The binomial rates from 8 time points (month 3-24) will be modeled as unstructured mean model with 7 indicator variables as well as polynomial models over time. The random-intercept and the random intercept and slope models will be considered. The significance of the time indicators or parameters by treatment interaction will be evaluated for treatment difference in compliance.
Measured: Up to 2 years
Number of Participants With Different Patient Reported Symptoms, Measured by Questionnaire
The outcomes will be scored as a 5-point Likert-type scale (0-4) in response to questions on how much the patients are bothered by certain symptoms. The questionnaire will be administered every 6 months. The responses will be treated as normally distributed, as ordinal or dichotomized variable, and the linear mixed effects of general linear mixed model (GLMM) methods will be applied to compare changes between treatment groups. Piecewise models will also be fitted with join point at 6 months, considering linear and curvilinear trajectories between 6 and 24 month time points.
Measured: Up to 2 years
Insulin Growth Factor Levels (IGF3 )
IGF3 will be treated as a continuous measure. The linear mixed effects model for between group comparisons of measures from 3 time points will be applied. The unstructured mean model and linear in time model will be employed.
Measured: Up to 2 years
Biomarker Levels - Alkaline Phosphatase
Serum bone-specific alkaline phosphatase measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time.
Measured: Up to 2 years
Biomarker Levels - Urine N-telopeptide
Urine n-telopeptide measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completion11 Dec 2018
- Study completion11 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), St. Jude Children's Research Hospital, University Health Network, Toronto, University of Michigan, Dana-Farber Cancer Institute, Mayo Clinic, University of Washington, City of Hope National Medical Center, M.D. Anderson Cancer Center, University of Chicago, University of Minnesota, University of Colorado, Denver, Wake Forest University
- Responsible party
- Principal investigator, Smitia Bhatia, University of Alabama at Birmingham
- Investigators
- Smita Bhatia, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196936
- Sponsor's protocol ID
- 08218
- Other IDs
- R01CA140245-01, NCI-2010-01976
- Acronym
- LDTam
- Status last verified
- Dec 2025
- First submitted
- 3 Sep 2010
- Last updated
- 5 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Tamoxifen for Radiation-Induced Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01196936
- Acronym / sponsor ID
- LDTam / 08218
- Conditions
- Breast Cancer
- Keywords
- Cancer survivors, Low Dose Tamoxifen, Breast Cancer Risk Reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), St. Jude Children's Research Hospital, University Health Network, Toronto, University of Michigan, Dana-Farber Cancer Institute, Mayo Clinic, University of Washington, City of Hope National Medical Center, M.D. Anderson Cancer Center, University of Chicago, University of Minnesota, University of Colorado, Denver, Wake Forest University
- Study start
- Sep 2010
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2028 (estimated)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells
This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (tamoxifen citrate) | Experimental | Drug: Tamoxifen Citrate, Procedure: Digital mammography, Other: immunohistochemistry staining method, Other: pharmacological study, Other: laboratory biomarker analysis, Genetic: protein expression analysis, Other: pharmacogenomic studies, Other: questionnaire administration, Procedure: Fine needle aspiration, Other: Quality of Life AssessmentPatients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity. |
| Arm II (placebo) | Placebo comparator | Drug: Placebo, Procedure: Digital mammography, Other: immunohistochemistry staining method, Other: pharmacological study, Other: laboratory biomarker analysis, Genetic: protein expression analysis, Other: pharmacogenomic studies, Other: questionnaire administration, Procedure: Fine needle aspiration, Other: Quality of Life AssessmentPatients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Exposure to radiation therapy (RT) delivered to the chest, axilla, and/or supraclavicular areas at a cumulative dose of 12 Gy or more by age 40 years; in addition, patients who received total body irradiation by age 40 may be considered
- 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:
Key exclusion criteria (19 listed)
- Subsequent malignant neoplasm (SMN) other than those listed below diagnosed within 2 years of study entry; patients with the listed indolent or pre-invasive neoplasms may be eligible if diagnosed within 2 years and all treatment was completed at least 6 months prior to registration:
- 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
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 CitrateAlso: Marketed under trade name Nolvadex as 10 mg and 20 mg tablets, ICI 46,4745 mg PO Daily | Drug | Arm I (tamoxifen citrate) |
| Placebo1 tablet daily | Drug | Arm II (placebo) |
| Digital mammographyCorrelative studies | Procedure or surgery | Arm I (tamoxifen citrate), Arm II (placebo) |
| immunohistochemistry staining methodCorrelative Studies | Other | Arm I (tamoxifen citrate), Arm II (placebo) |
| pharmacological studyCorrelative Studies | Other | Arm I (tamoxifen citrate), Arm II (placebo) |
| laboratory biomarker analysisCorrelative Studies | Other | Arm I (tamoxifen citrate), Arm II (placebo) |
| protein expression analysiscorrelative studies | Genetic | Arm I (tamoxifen citrate), Arm II (placebo) |
| pharmacogenomic studiescorrelative studies | Other | Arm I (tamoxifen citrate), Arm II (placebo) |
| questionnaire administrationAncillary studies | Other | Arm I (tamoxifen citrate), Arm II (placebo) |
| Fine needle aspirationAlso: Correlative studies | Procedure or surgery | Arm I (tamoxifen citrate), Arm II (placebo) |
| Quality of Life AssessmentAncillary Studies | Other | Arm I (tamoxifen citrate), Arm II (placebo) |
Primary outcome
Mammographic Breast Density
Time frame: At year two post treatment
Mammographic density was quantified as percentage of fibroglandular tissue. Using an intention-to-treat analysis, mammographic breast density (MBD) was compared between patients in the low dose tamoxifen intervention and placebo group by applying the linear mixed effects model for normally distributed data.
8 secondary outcomes
Insulin Growth Factor Levels (IGF1)
Time frame: Up to 2 years
Number of Grade 2-4 Toxicities
Time frame: Up to 2 years
Biomarker Levels
Time frame: Up to 2 years
Percentage of Pills Taken Out of the Total Prescribed
Time frame: Up to 2 years
Number of Participants With Different Patient Reported Symptoms, Measured by Questionnaire
Time frame: Up to 2 years
Insulin Growth Factor Levels (IGF3 )
Time frame: Up to 2 years
Biomarker Levels - Alkaline Phosphatase
Time frame: Up to 2 years
Biomarker Levels - Urine N-telopeptide
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Smita Bhatia, MD principal investigator
University of Alabama at Birmingham
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen Citrate, Digital mammography and immunohistochemistry staining method in people with Breast Cancer, run by University of Alabama at Birmingham at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mammographic Breast Density (time frame: At year two post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.