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

• Status: Terminated
• Trial end date: 2018-12-20
• Target enrollment: 0
• Participant gender: Female

Summary

A 2 arm, 90 patient (45 per cohort) trial in patients with breast cancer who will be undergoing mastectomy with immediate tissue-expander reconstruction to determine whether treatment with zafirlukast (20mg PO BID) can reduce or prevent the development of capsular contracture.

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

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Leukotriene Antagonists; Zafirlukast

Criteria

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.