Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

A randomized, double-blind, placebo-controlled trial assessing Losartan in reducing radiation induced fibrosis in breast cancer patients undergoing standard of care radiation therapy after surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaw Cancer Center
• Collaborator: Steadman Philippon Research Institute
• Treatments: Losartan

Criteria

Inclusion Criteria:

1. 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)

2. Has been treated with breast conserving surgery or mastectomy with reconstruction

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

4. Age ≥ 18

5. Female

Inclusion of Women and Minorities: Women of any race and any ethnicity are eligible for this trial. Women who are pregnant or nursing are excluded from this trial.

Exclusion Criteria:

1. Recurrent breast cancer or history of prior breast radiation therapy

2. Breast cancer requiring bilateral breast/chest wall radiation therapy

3. Breast conservation surgery patients with contralateral breast reduction prior to radiation

4. History of post-surgical infection

5. Undergoing concurrent chemotherapy treatment

6. Documented fall risk

7. Active known or suspected systemic autoimmune disease (except for vitiligo, residual auto-immune hypothyroidism requiring hormone replacement only, psoriasis not requiring systemic treatment for two years, conditions not expected to recur in the absence of an external trigger) or any history of a systemic inflammatory arthritis such as psoriatic, rheumatoid, systemic lupus, ankylosing spondylitis or reactive arthritis

8. Uncontrolled intercurrent illness including, but not limited to:

• Hyperkalemia

• Impaired renal function

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Kidney disease

• Uncontrolled diabetes

• Cystic fibrosis

• Fibromyalgia based on American College of Rheumatology criteria

9. Concomitant use of:

• Other Renin-Angiotensin System (RAS) agent

• Agents to increase serum potassium

• Lithium

• Aliskiren for diabetes

10. Having a known allergy to any active or inactive ingredient in Losartan

11. Unable to tolerate oral medication

12. Pregnant or breast-feeding or planning pregnancy for the year following radiation

13. Individuals known to possess DNA repair genes 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

14. Patients with any medical condition, including findings in laboratory or medical history or in the baseline assessments, that (in the opinion of the Principal Clinical Investigator or his/her designee), constitutes a risk or contraindication for participation in the study or that could interfere with the study conduct, endpoint evaluation or prevent the subject from fully participating in all aspects of the study