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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

LDTam Trial 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.Check my eligibility

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.See study design

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.

LDTam Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I received radiation therapy in the chest area or total body irradiation of 12 Gy or more by age 40.

Select...

I am 45 or younger and have had regular periods for the last 6 months.

LDTam Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at year two post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at year two post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at year two post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mammographic Breast Density

Secondary outcome measures

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

82%

Fatigue

45%

Hot flashes

42%

Anorexia

39%

Constipation

27%

Pain

27%

Generalized muscle weakness

21%

Back pain

18%

Diarrhea

18%

Headache

18%

Hypertension

18%

Dizziness

18%

Nausea

15%

Weight loss

15%

Arthralgia

15%

Upper respiratory infection

12%

Abdominal pain

12%

Memory impairment

12%

Peripheral sensory neuropathy

12%

Hematuria

12%

Vomiting

12%

Fall

12%

Pain in extremity

12%

Urinary frequency

Dyspnea

Pelvic pain

Hyperglycemia

General disorders and administration site conditions - Other

Anxiety

Edema limbs

Breast pain

Alopecia

Ear pain

Flank pain

Urinary incontinence

White blood cell decreased

Renal and urinary disorders - Other

Investigations - Other

Cystitis noninfective

Fracture

Hypokalemia

Weight gain

Watering eyes

Paresthesia

Neoplasms benign, malignant and unspecified

Flu like symptoms

Arthritis

Bone pain

Cough

Urinary retention

Neutrophil count decreased

Small intestinal obstruction

Depression

Dyspepsia

Platelet count decreased

Confusion

Ileus

Skin and subcutaneous tissue disorders - Other

Skin infection

Non-cardiac chest pain

Blurred vision

Muscle weakness lower limb

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Enzalutamide, Mifepristone)

Treatment (Enzalutamide)

Not Randomized

LDTam 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

~3750

Fine needle aspiration

2015

N/A

~290

protein expression analysis

2005

Completed Phase 2

~1100

Digital mammography

2016

N/A

~29460

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER

1,738 Previous Clinical Trials

1,844,267 Total Patients Enrolled

19 Trials studying Breast Cancer

3,169 Patients Enrolled for Breast Cancer

City of Hope National Medical CenterOTHER

15 Previous Clinical Trials

3,797 Total Patients Enrolled

4 Trials studying Breast Cancer

2,074 Patients Enrolled for Breast Cancer

University of ChicagoOTHER

1,001 Previous Clinical Trials

817,646 Total Patients Enrolled

25 Trials studying Breast Cancer

4,675 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Research Study Groups: Arm I (tamoxifen citrate), Arm II (placebo)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What locations are offering access to this clinical trial?

"The clinical trial is being conducted at multiple centres, including St. Jude Children's Research Hospital in Memphis, Tennessee, City of Hope Medical Center in Duarte, California and Mayo Clinic in Rochester, Minnesota amongst 13 other prominent sites."

Answered by AI

Are there any other investigations utilizing pharmacological research techniques?

"Presently, 67 clinical trials exploring pharmacological study are underway. 22 of these studies have proceeded to Phase 3 and can be found in Ann Arbor, Michigan as well as 7276 other locations."

Answered by AI

How many individuals are currently participating in this research endeavor?

"This clinical experiment is not currently recruiting. It was initially released on the 1st of September in 2010, and its most recent update occurred on April 12th 2022. However, those seeking to participate in other studies may have better luck - there are 2596 medical trials related to breast cancer presently admitting patients as well as 67 drug-based investigations open for enrollment."

Answered by AI

What safeguards are in place to protect participants during pharmacological research?

"The safety rating of this pharmacological study is 2, as it currently exists in Phase 2. This suggests that there are some studies to support its security but no evidence for efficacy."

Answered by AI

What kinds of illnesses are studied with pharmaceutical research?

"Pharmacological study is commonly prescribed to combat malignant neoplasms, and has been used in the past to treat ovarian cancer, induce ovulation, or prevent high risk outcomes."

Answered by AI

Is there an ongoing recruitment process for this investigation?

"At this moment in time, no participants are being accepted for the clinical trial in question. This particular research endeavour was initially posted on September 1st 2010 and most recently updated April 12th 2022. If you're searching other studies, there are 2596 trials related to breast cancer that are actively recruiting patients as well as 67 pharmacological experiments doing the same."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors

Smitia Bhatia 2010. "Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01196936.

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