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Selective Estrogen Receptor Modulator

Tamoxifen for Breast Cancer Risk after Radiation Therapy (LDTam Trial)

Phase 2
Waitlist Available
Led By Smita Bhatia, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Premenopausal, defined as age at registration 45 years old or younger with regular monthly period for at least 6 consecutive months prior to registration
Must not have
Cervical cancer confined to the cervix or cervical intraepithelial neoplasia (CIN)
Bilateral breast implants or status-post bilateral prophylactic mastectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years

Summary

This trial looks at how well tamoxifen citrate works in reducing breast cancer risk in people who have had radiation therapy.

Who is the study for?
This trial is for radiation-induced cancer survivors who are at risk of breast cancer, have had chest radiation therapy by age 40, and have been disease-free for 2 years. Postmenopausal women or premenopausal women under 45 with regular periods can join. Exclusions include those with certain other cancers, recent hormone treatments, pregnancy plans within two years, or a history of blood clots.
What is being tested?
The study tests if low-dose tamoxifen citrate can reduce the risk of developing breast cancer in individuals previously treated with chest radiation. It involves comparing tamoxifen to a placebo and includes various assessments like mammography and questionnaires about quality of life.
What are the potential side effects?
Tamoxifen may cause hot flashes, vaginal symptoms, leg cramps, increased risk of blood clots and cataracts. Some people might experience fatigue or mood changes. The severity varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I received radiation therapy in the chest area or total body irradiation of 12 Gy or more by age 40.
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I am 45 or younger and have had regular periods for the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cervical cancer has not spread beyond my cervix.
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I have breast implants or have had both breasts removed as a preventive measure.
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I have a non-invasive breast condition.
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My bladder cancer is on the surface and has not spread deeply.
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I am unable to give my consent.
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I have a type of skin cancer that is not melanoma.
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I am not taking warfarin or strong CYP2D6 inhibitors together.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mammographic Breast Density
Secondary study objectives
Biomarker Levels
Biomarker Levels - Alkaline Phosphatase
Biomarker Levels - Urine N-telopeptide
+5 more

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02012296
76%
Fatigue
58%
Hot flashes
30%
Diarrhea
30%
Pain
27%
Hyperglycemia
24%
Back pain
18%
Nausea
18%
Dizziness
18%
Dyspnea
18%
Arthralgia
15%
Anorexia
15%
Depression
15%
Anxiety
15%
Hypertension
15%
Edema limbs
15%
Headache
15%
Pain in extremity
12%
Urinary frequency
12%
Constipation
12%
Cough
12%
Fall
12%
Abdominal pain
12%
Arthritis
12%
Bone pain
9%
Urinary incontinence
9%
Insomnia
9%
Flank pain
9%
Generalized muscle weakness
9%
Genital edema
9%
Hematuria
9%
Memory impairment
9%
Platelet count decreased
9%
Pruritis
9%
Anemia
6%
Renal calculi
6%
Sinus disorder
6%
Confusion
6%
Dyspepsia
6%
Muscle weakness lower limb
6%
Peripheral sensory neuropathy
6%
Renal and urinary disorders - Other
6%
Skin and subcutaneous tissue disorders - Other
6%
Vomiting
6%
Alkaline phosphatase increase
6%
Blood bilirubin increased
6%
Blurred vision
3%
Skin infection
3%
Alopecia
3%
Cystitis noninfective
3%
Fracture
3%
General disorders and administration site conditions - Other
3%
Hypokalemia
3%
Upper respiratory infection
3%
Weight gain
3%
Infections and infestations - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzalutamide)
Treatment (Enzalutamide, Mifepristone)
Not Randomized

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (tamoxifen citrate)Experimental Treatment10 Interventions
Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (placebo)Placebo Group10 Interventions
Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen Citrate
2011
Completed Phase 3
~3780
Fine needle aspiration
2015
N/A
~290
protein expression analysis
2005
Completed Phase 2
~1080
Digital mammography
2016
N/A
~29460

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER
1,824 Previous Clinical Trials
1,913,271 Total Patients Enrolled
19 Trials studying Breast Cancer
3,169 Patients Enrolled for Breast Cancer
City of Hope National Medical CenterOTHER
16 Previous Clinical Trials
8,791 Total Patients Enrolled
4 Trials studying Breast Cancer
2,068 Patients Enrolled for Breast Cancer
University of ChicagoOTHER
1,058 Previous Clinical Trials
765,547 Total Patients Enrolled
25 Trials studying Breast Cancer
4,675 Patients Enrolled for Breast Cancer
University of Alabama at BirminghamLead Sponsor
1,648 Previous Clinical Trials
2,344,441 Total Patients Enrolled
31 Trials studying Breast Cancer
4,360 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,104 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,174 Patients Enrolled for Breast Cancer
St. Jude Children's Research HospitalOTHER
443 Previous Clinical Trials
5,305,397 Total Patients Enrolled
University Health Network, TorontoOTHER
1,527 Previous Clinical Trials
503,462 Total Patients Enrolled
54 Trials studying Breast Cancer
29,681 Patients Enrolled for Breast Cancer
University of MichiganOTHER
1,860 Previous Clinical Trials
6,437,836 Total Patients Enrolled
24 Trials studying Breast Cancer
17,149 Patients Enrolled for Breast Cancer
Mayo ClinicOTHER
3,353 Previous Clinical Trials
3,060,939 Total Patients Enrolled
83 Trials studying Breast Cancer
14,712 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteOTHER
1,110 Previous Clinical Trials
358,214 Total Patients Enrolled
144 Trials studying Breast Cancer
20,121 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Research Study Groups: Arm I (tamoxifen citrate), Arm II (placebo)
~6 spots leftby Dec 2025
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