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Losartan for Radiation-Induced Fibrosis in Breast Cancer

Phase 2

Recruiting

Led By Patricia H Hardenbergh, MD

Research Sponsored by Shaw Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with clinical or pathologic stage 0-IV invasive breast cancer to include ductal carcinoma in situ (Tis), primary tumor cannot be assessed (TX) and all other primary tumor stage categories (T1-T4)

Is a candidate for unilateral post-surgery radiation therapy per National Comprehensive Cancer Network (NCCN) guidelines

Must not have

Individuals known to possess deoxyribonucleic acid (DNA) gene mutations including Ataxia-Telangiectasia Mutated (ATM), Double-strand-break repair protein rad21 homolog (RAD21), C-to-T single-nucleotide polymorphism (C-509T) in the Transforming growth factor β-1 gene

Recurrent breast cancer or history of prior breast radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years following the completion of radiation therapy

Summary

This trial tested a drug to reduce skin hardening caused by radiation therapy in breast cancer patients.

Who is the study for?

This trial is for women over 18 with stage 0-IV breast cancer who've had surgery and are set for radiation therapy. They must have normal kidney and liver function, not be pregnant or breastfeeding, and can't have autoimmune diseases, a history of certain conditions, or be on conflicting medications.

What is being tested?

The study tests if Losartan, a drug that blocks TGF-β1 involved in fibrosis, can reduce scarring in the lung and breast from radiation treatment in breast cancer patients compared to a placebo.

What are the potential side effects?

Losartan may cause dizziness due to low blood pressure, increased potassium levels which could affect heart rhythm, mild swelling or weight gain from fluid retention, and possible kidney function changes.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with breast cancer at any stage.

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I am eligible for radiation therapy on one side after surgery, as per NCCN guidelines.

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I am 18 years old or older.

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I am female.

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I have had surgery to remove or reconstruct my breast.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have specific genetic mutations related to cancer.

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My breast cancer has come back or I've had radiation therapy for it before.

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I do not have any uncontrolled illnesses like heart failure, unstable angina, kidney disease, uncontrolled diabetes, cystic fibrosis, or fibromyalgia.

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My breast cancer treatment includes radiation therapy for both breasts.

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I am currently receiving chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years following the completion of radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years following the completion of radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years following the completion of radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average levels of cellular senescence, transforming growth factor beta-1 (TGF-β1) and senescence-associated secretory phenotype (SASP) serum biomarkers

Fibrosis of the breast or reconstructed breast in irradiated breast cancer patients

Radiographic lung fibrosis in the radiation field of irradiated breast cancer patients

Secondary study objectives

Change in breast volume

Cosmesis

Patient reported outcomes

+1 more

Other study objectives

Incidence of Reoperation

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Mastectomy with LosartanExperimental Treatment1 Intervention

Participants who underwent a mastectomy will take losartan in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.

Group II: Breast Conservation Surgery with LosartanExperimental Treatment1 Intervention

Participants who underwent breast conservation surgery will take losartan in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.

Group III: Mastectomy with PlaceboPlacebo Group1 Intervention

Participants who underwent a mastectomy will take placebo in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.

Group IV: Breast Conservation Surgery with PlaceboPlacebo Group1 Intervention

Participants who underwent breast conservation surgery will take placebo in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.

0 / 10Eligibility criteria met