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

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02950480

Run by

University of California, San Francisco

People needed

4

Starts

2017-03-13

Expected to finish

2018-12-20

Last updated by the study team

2019-10-01

Who can join

Age: 18 and older, up to 89. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Age ≥ 18 years
• 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.
• Ability to understand a written informed consent document, and the willingness to sign it
• At least 4 weeks post-completion of chemotherapy
• Adequate organ function within 14 days start of study start:
• Absolute neutrophil count (ANC) ≥ 1.5 X 10\^9/L
• Hemoglobin (Hgb) ≥9g/dL
• Platelets (plt) ≥ 100 x 10\^9/L
• Potassium within normal range, or correctable with supplements;
• AST and ALT ≤2.5 x Upper Limit Normal (ULN) or ≤5.0 x ULN if liver tumor is present;
• Serum total bilirubin ≤ 1.5 x ULN
• Serum creatinine ≤ 1.5 x ULN, or 24-hr clearance ≥ 60ml/min

You may not qualify if…

• Any significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
• Currently on a leukotriene inhibitor or used within the past 6 months
• Prior chest wall radiation
• Pregnant or breastfeeding
• Hepatic impairment as defined by:
• AST(SGOT) > 2.5X institutional ULN and ALT(SGPT) > 2.5X institutional ULN
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Where it is running

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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