Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial

Inclusion Criteria:

1. Patients who are scheduled to undergo therapeutic or prophylactic mastectomy with immediate placement of tissue expanders and have a strong family history or hereditary cancer
2. Age ≥ 18 years
3. Zafirlukast is pregnancy category B. There are no adequate and well-controlled trials in pregnant women. Therefore, the effects of zafirlukast on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception: 2 methods of birth control, prior to study entry ad for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
4. Ability to understand a written informed consent document, and the willingness to sign it
5. At least 4 weeks post-completion of chemotherapy
6. Adequate organ function within 14 days start of study start:

   1. Absolute neutrophil count (ANC) ≥ 1.5 X 10\^9/L
   2. Hemoglobin (Hgb) ≥9g/dL
   3. Platelets (plt) ≥ 100 x 10\^9/L
   4. Potassium within normal range, or correctable with supplements;
   5. AST and ALT ≤2.5 x Upper Limit Normal (ULN) or ≤5.0 x ULN if liver tumor is present;
   6. Serum total bilirubin ≤ 1.5 x ULN
   7. Serum creatinine ≤ 1.5 x ULN, or 24-hr clearance ≥ 60ml/min

Exclusion Criteria:

1. Any significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
2. Currently on a leukotriene inhibitor or used within the past 6 months
3. Prior chest wall radiation
4. Pregnant or breastfeeding
5. Hepatic impairment as defined by:

   • AST(SGOT) \> 2.5X institutional ULN and ALT(SGPT) \> 2.5X institutional ULN
6. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.