Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Le… (NCT02950480) | Clinical Trial Compass
TerminatedPhase 2
Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial
Stopped: Low accrual.
United States4 participantsStarted 2017-03-13
Plain-language 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.
Who can participate
Age range18 Years – 89 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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