This randomized phase II trial studies how well zafirlukast works in treating patients with tightening of scar tissue that form around the breast after mastectomy. Zafirlukast may block the action of certain natural substances that cause swelling and tightening of the airways.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02950480.
PRIMARY OBJECTIVES:
I. Compare capsular thickness by gross and microscopic measurement at the time of expander-implant exchange in those treated with zafirlukast (20 mg orally [PO] twice daily [BID]) compared with standard of care.
SECONDARY OBJECTIVES:
I. Perform histologic analysis of the capsule specimens to compare overall fibrosis and collagen deposition between the zafirlukast and standard of care groups.
TERTIARY OBJECTIVES:
I. The capsule tissue that is removed at the time of expander-implant exchange will be fixed and histologically assessed for the presence of fibroblasts and myofibroblasts.
OUTLINE: Patients are randomized to 1 of 2 cohorts.
COHORT A: Beginning the day after surgery, patients receive zafirlukast PO BID until tissue expansion is complete in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.
COHORT B: Patients receive standard of care.
After completion of study treatment, patients are followed up at 30 days, every 2 weeks for 1 month, every month for 4 months, and then every 6 months for up to 2 years.
Lead OrganizationUCSF Medical Center-Mount Zion
Principal InvestigatorPamela N. Munster
