An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

Completed · Phase 2

Conditions studied: Early Stage HER2+ Breast Cancer

In brief

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.

Key facts

Study ID

NCT02400476

Run by

Puma Biotechnology, Inc.

People needed

563

Starts

2015-02-01

Expected to finish

2021-04-22

Last updated by the study team

2022-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18; male or female
• Early breast cancer (stage I-3c)
• Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+
• Prior course of adjuvant trastuzumab given >2 weeks and ≤1 year from enrollment
• No evidence of local/regional recurrence or metastatic disease
• Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
• Male patients with female partners of childbearing potential must agree and commit to use a condom and women of childbearing potential must not be pregnant and must agree and commit to the use of a highly effective non-hormonal method of contraception
• Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or ECHO

You may not qualify if…

• Major surgery < 30 days
• Chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) < 14 days
• Corrected QT Interval (QTc) >0.450 seconds (males) or >0.470 (females) or other active cardiac disease
• Significant chronic GI disorder with diarrhea as a major symptom
• Active, unresolved infections
• Currently pregnant or breast-feeding

Where it is running

• Compassionate Care Research Group Inc. — Corona, California, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Emad Ibrahim, M.D., Inc. — Redlands, California, United States
• Torrance Memorial Physician Network Cancer Care Associates — Redondo Beach, California, United States
• Compassionate Care Research Group Inc. — Riverside, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• The Oncology Institute of Hope and Innovation — Santa Ana, California, United States
• Cancer Center of Santa Barbara with Sansum Clinic — Santa Barbara, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Florida Cancer Research Institute, LLC — Plantation, Florida, United States
• Hematology-Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• Baptist Health Urgent Care Sawgrass — Sunrise, Florida, United States
• Cancer Treatment Centers of America — Newnan, Georgia, United States
• Decatur Memorial Hospital Cancer Care Specialists of Central Illinois — Decatur, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Central Maine Medical Center — Lewiston, Maine, United States
• University of Maryland, Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
• North Mississippi Medical Center Hematology and Oncology Services — Tupelo, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Great Plains Health (Callahan Cancer Center) — North Platte, Nebraska, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• Alabama Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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