Breast Cancer Clinical Trial

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Summary

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.

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Full Description

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. The study has a basket design and includes several cohorts, either defined by an actionable somatic mutation or by actionable mutation and tumor histology, including HER2 mutant breast, HER2 mutant cervical, HER2 mutant salivary gland, and EGFR Exon 18 mutant Non-small cell lung cancers.

The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Provide written informed consent
Histologically confirmed cancers for which no curative therapy exists
Documented HER2 or EGFR exon 18 mutation
Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol
At least one measurable lesion, defined by RECIST v1.1

Exclusion Criteria:

Participants harboring ineligible somatic HER2 mutations
Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible
Participants who are receiving any other anticancer agents
Symptomatic or unstable brain metastases
Women who are pregnant or breast-feeding

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

582

Study ID:

NCT01953926

Recruitment Status:

Active, not recruiting

Sponsor:

Puma Biotechnology, Inc.

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There are 56 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
City of Hope
Duarte California, 91010, United States
University of California, San Diego
La Jolla California, 92093, United States
University of Southern California
Los Angeles California, 90089, United States
University of California, Los Angeles
Los Angeles California, 90095, United States
Stanford Cancer Center
Palo Alto California, 94304, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Kaiser Permanente NoCal (STRATA)
Vallejo California, 94589, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, United States
University of Miami
Miami Florida, 33136, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Northwestern University
Chicago Illinois, 60611, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park Minnesota, 55416, United States
Washington University
Saint Louis Missouri, 63110, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
UPMC Magee-Woman's Hospital, Women's Cancer Center
Pittsburgh Pennsylvania, 15213, United States
Saint Francis Cancer Center-Bon Secours
Greenville South Carolina, 29607, United States
The West Clinic
Germantown Tennessee, 38138, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Gundersen Center for Cancer and Blood Disorders
La Crosse Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
Peter MacCallum Cancer Centre
East Melbourne Victoria, 8006, Australia
UZ Leuven
Leuven , 3000, Belgium
British Columbia Cancer Center
Vancouver British Columbia, V5Z 4, Canada
University Hospital, Rigshospitalet
Kopenhagen , DK-21, Denmark
Institut Curie - Hopital Rene Huguenin
Saint-Cloud Ile De France, 92210, France
Institut Gustave Roussy
Villejuif Paris, 94800, France
Institut Bergonié
Bordeaux , 33076, France
Centre Leon Berard
Lyon , 69393, France
St. Vincent's University Hospital
Dublin Leinster, D04 T, Ireland
Hadassah Medical Center
Jerusalem , 91120, Israel
Davidoff Cancer Center, Rabin Medical Center
Petah Tikva , 49414, Israel
Sheba Medical Center
Ramat Gan , 52620, Israel
Kaplan Medical Center
Rehovot , 76610, Israel
Sourasky Medical Center
Tel Aviv , 64239, Israel
Azienda Socio Sanitaria Territoriale di Cremona
Cremona , 26100, Italy
AOU Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Yonsei University Health System, Serverance Hospital
Seodaemun-Gu Seoul, 120-7, Korea, Republic of
Institute for Oncology and Radiology of Serbia
Belgrade , 11000, Serbia
Hospital Universitario Quiron Dexeus
Barcelona , 08028, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitari Clinic Barcelona
Barcelona , 08036, Spain
Hospital Clinico Universitario San Carlos
Madrid , 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario Madrid Sanchinarro (START Madrid)
Madrid , 28050, Spain
Hospital Universitario Quiron Madrid
Madrid , 28223, Spain
Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Royal Free Hospital
London , NW3 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

582

Study ID:

NCT01953926

Recruitment Status:

Active, not recruiting

Sponsor:


Puma Biotechnology, Inc.

How clear is this clinincal trial information?

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