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

NCT02950480 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 15754
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Mastectomy

Outcome Measures

Primary Outcomes (1)

• Capsular Thickness

  Compare capsular thickness by gross and microscopic measurement at the time of expander-implant exchange in those treated with zafirlukast (20 mg PO BID) compared with standard of care.

  Day 44 to Day 126

Secondary Outcomes (2)

• Histologic Analysis: Compare Capsular Thickness by Gross and Microscopic Measurement at the Time of Expander-implant Exchange in Those Treated With Zafirlukast (20 mg PO BID) Compared With Standard of Care

  Day 44 to Day 126

• Appearance of Capsular Contracture

  After Day 44 to Day 126

Study Arms (2)

Zafirlukast

EXPERIMENTAL

Zafirlukast

Drug: zafirlukast

Standard of Care (no intervention)

OTHER

Standard of Care (no intervention)

Other: Standard of Care (no intervention)

Interventions

zafirlukast DRUG

Patients will begin treatment with zafirlukast on post-operative day one following placement of tissue expander(s) once determined safe from a surgical recovery standpoint. They will be continued on the standard dosing (20mg PO twice per day) of zafirlukast through expander fill (6-12 weeks, up to 18 weeks for women receiving radiation). Treatment will be stopped 48 hours prior to expander-implant exchange, which is equivalent to five half-lives of the drug. Patients will be seen every 1 to 2 weeks for expander fill, and will be assessed clinically based on the Baker classification system of capsular contracture every two weeks.

Also known as: Accolate

Zafirlukast

Standard of Care (no intervention) OTHER

Standard of Care (no intervention)

Standard of Care (no intervention)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143-1711, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

zafirlukast; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Pamela Munster
• Organization: University of California, San Francisco

pamela.munster@ucsf.edu

(415) 885-7810

Study Officials

• Pamela N Munster, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: November 1, 2016
• Study Start: March 13, 2017
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: October 1, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-09

Locations

US (1)