Early Stage HER2+ Breast Cancer Clinical Trial
Official title:
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
| Verified date | January 2021 |
| Source | Puma Biotechnology, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 563 |
| Est. completion date | April 22, 2021 |
| Est. primary completion date | April 22, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Ashford Cancer Centre Research | Kurralta Park | South Australia |
| Australia | BCRC-WA, Hollywood Private Hospital | Nedlands | Western Australia |
| Australia | Sydney Adventist Hospital | Wahroonga | New South Wales |
| Austria | Univ. Klinik für Innere Medizin, Klin. Abt. Onkologie | Graz | |
| Austria | Medical University of Innsbruck-Department of Gynecology | Innsbruck | |
| Austria | Uniklinikum Salzburg, Landeskrankenhaus, Univ. Klinik fur Innere Medizin III der PMU | Salzburg | |
| Austria | Medical University of Vienna, Department of Oncology | Vienna | |
| Austria | Medical University of Vienna,Department of Obstetrics and Gynecology | Vienna | |
| Canada | McGill University Health Centre, Cedars Cancer Centre | Montreal | Quebec |
| Canada | Sunnybrook Research Insitute | Toronto | Ontario |
| France | CHU Group Hospitalier Pitié-Salpêtrière, Service d'oncologie Médicale | Paris | |
| France | Institut Gustave Roussy | Villejuif | |
| Germany | Praxis für interdisziplinäre Onkologie & Hämatologie | Freiburg | |
| Germany | Mammazentrum HH am Krankenhaus Jerusalem | Hamburg | |
| Germany | Universitaetsklinikum Schleswig-Holstein | Kiel | |
| Germany | Universitaetsklinikum Schleswig-Holstein (UKSH), Klinik fuer Gynaekologie und Geburtshilfe, Studienzentrale Gynäkologische Onkologie (SGC) Kiel | Kiel | |
| Germany | Sana Klinikum Offenbach GmbH - Frauenklinik | Offenbach | |
| Spain | Hospital Clinico San Carlos | Madrid | |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
| United States | University of Maryland, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland |
| United States | Alabama Oncology | Birmingham | Alabama |
| United States | Charleston Hematology Oncology Associates | Charleston | South Carolina |
| United States | Compassionate Care Research Group Inc. | Corona | California |
| United States | Coastal Bend Cancer Center | Corpus Christi | Texas |
| United States | Good Samaritan Hospital Samaritan Pastega Regional Cancer Center | Corvallis | Oregon |
| United States | Decatur Memorial Hospital Cancer Care Specialists of Central Illinois | Decatur | Illinois |
| United States | Inova Schar Cancer Institute | Fairfax | Virginia |
| United States | St. Joseph Heritage Healthcare | Fullerton | California |
| United States | Ingalls Memorial Hospital | Harvey | Illinois |
| United States | Saint Joseph / Candler SC Cancer Specialists | Hilton Head Island | South Carolina |
| United States | Memorial Healthcare System | Hollywood | Florida |
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Clinical Research Alliance, Inc | Lake Success | New York |
| United States | Central Maine Medical Center | Lewiston | Maine |
| United States | Saint Barnabas Medical Center | Livingston | New Jersey |
| United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
| United States | Norton Cancer Institute | Louisville | Kentucky |
| United States | Jersey Shore University Medical Center | Neptune | New Jersey |
| United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
| United States | Cancer Treatment Centers of America | Newnan | Georgia |
| United States | Great Plains Health (Callahan Cancer Center) | North Platte | Nebraska |
| United States | Community Cancer Trials of Utah | Ogden | Utah |
| United States | Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania |
| United States | Florida Cancer Research Institute, LLC | Plantation | Florida |
| United States | Hematology-Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida |
| United States | Providence Portland Medical Center | Portland | Oregon |
| 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 | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Utah Cancer Specialists | Salt Lake City | Utah |
| 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 | Baptist Health Urgent Care Sawgrass | Sunrise | Florida |
| United States | North Mississippi Medical Center Hematology and Oncology Services | Tupelo | Mississippi |
| United States | MD Anderson Cancer Center at Cooper | Voorhees | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Puma Biotechnology, Inc. |
United States, Australia, Austria, Canada, France, Germany, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0. | The primary objective of this study is to characterize the percentage of patients with Grade 3 or higher diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. Grade 3: Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. | From first dose of investigational product through 28 days after last dose, up to 15.5 months. | |
| Secondary | Percentage of Patients With Diarrhea by Grade, According to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), Version 4.0. | Assess the percentage of patients with diarrhea after the administration of an anti-inflammatory agent, a bile acid sequestrant, or following two different dose-escalation regimens of neratinib, by maximum CTC grade. Grade 1: an increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline. Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline. Grade 3: Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. | From first dose of investigational product through 28 days after last dose, up to 15.5 months. | |
| Secondary | Percentage of Patients With Serious Adverse Events and Other Adverse Events of Special Interest | Assess the percentage of patients with serious adverse events (SAEs) and other adverse events of special interest (AESI). AESIs were selected based on the known safety profile of neratinib as well as typical key body system toxicity concerns generally reviewed for any new drug. These AESIs were grouped into the following categories: gastrointestinal toxicity (diarrhea and stomatitis), hepatotoxicity, pulmonary toxicity (interstitial lung disease), cardiac toxicity (LVEF decreased), and dermatologic toxicity (rash and nail disorders). The AESIs were analyzed by searching the clinical database for all TEAEs and SAEs using either Standardized MedDRA Queries (SMQs) or, if an applicable SMQ did not exist, a Sponsor-defined list of MedDRA preferred terms. | From first dose of investigational product through 28 days after last dose, up to 15.5 months. |