Brief Summary

This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.

Conditions

• Malignant Female Reproductive System Neoplasm
• Malignant Solid Neoplasm
• Recurrent Malignant Female Reproductive System Neoplasm
• Recurrent Malignant Solid Neoplasm

Intervention / Treatment

• Procedure: Biopsy Procedure
• Procedure: Biospecimen Collection
• Procedure: Computed Tomography
• Procedure: Echocardiography Test
• Procedure: Magnetic Resonance Imaging
• Procedure: Multigated Acquisition Scan
• Drug: Neratinib Maleate
• Drug: Palbociclib

Primary Outcome Measures

• Progression free survival (From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 2 years)
  The stratified log-rank statistic will be used to draw inferences about the relative activity of the two regimens. Characterized by medians and Kaplan-Meier (KM) curves.

Countries

Puerto Rico, United States

Locations and Investigators

• University of Alabama at Birmingham Cancer Center, Birmingham, United States (Recruiting)
  • Site Public Contact
  • Rebecca C. Arend (Principal Investigator)
• University of South Alabama Mitchell Cancer Institute, Mobile, United States (Recruiting)
  • Site Public Contact
  • Ahmed Abdalla (Principal Investigator)
• Alaska Women's Cancer Care, Anchorage, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• UC San Diego Health System - Encinitas, Encinitas, United States (Recruiting)
  • Site Public Contact
  • Peter Vu (Principal Investigator)
• UC San Diego Moores Cancer Center, La Jolla, United States (Recruiting)
  • Site Public Contact
  • Peter Vu (Principal Investigator)
• The Angeles Clinic and Research Institute - West Los Angeles Office, Los Angeles, United States (Recruiting)
  • Site Public Contact
  • Omid Hamid (Principal Investigator)
• Cedars-Sinai Medical Center, Los Angeles, United States (Recruiting)
  • Site Public Contact
  • Omid Hamid (Principal Investigator)
• UC San Diego Medical Center - Hillcrest, San Diego, United States (Recruiting)
  • Site Public Contact
  • Peter Vu (Principal Investigator)
• UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, United States (Recruiting)
  • Site Public Contact
  • Matthew P. Schlumbrecht (Principal Investigator)
• UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, United States (Recruiting)
  • Site Public Contact
  • Matthew P. Schlumbrecht (Principal Investigator)
• UM Sylvester Comprehensive Cancer Center at Coral Springs, Coral Springs, United States (Recruiting)
  • Site Public Contact
  • Matthew P. Schlumbrecht (Principal Investigator)
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, United States (Recruiting)
  • Site Public Contact
  • Matthew P. Schlumbrecht (Principal Investigator)
• University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, United States (Recruiting)
  • Site Public Contact
  • Matthew P. Schlumbrecht (Principal Investigator)
• UM Sylvester Comprehensive Cancer Center at Kendall, Miami, United States (Recruiting)
  • Site Public Contact
  • Matthew P. Schlumbrecht (Principal Investigator)
• University of Miami Sylvester Comprehensive Cancer Center at Sole Mia, North Miami, United States (Recruiting)
  • Site Public Contact
  • Matthew P. Schlumbrecht (Principal Investigator)
• UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, United States (Recruiting)
  • Site Public Contact
  • Matthew P. Schlumbrecht (Principal Investigator)
• Saint Alphonsus Cancer Care Center-Boise, Boise, United States (Recruiting)
  • Site Public Contact
  • Tareq Al baghdadi (Principal Investigator)
• Saint Luke's Cancer Institute - Boise, Boise, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, United States (Recruiting)
  • Site Public Contact
  • Tareq Al baghdadi (Principal Investigator)
• Kootenai Health - Coeur d'Alene, Coeur d'Alene, United States (Recruiting)
  • Site Public Contact
  • John M. Schallenkamp (Principal Investigator)
• Saint Luke's Cancer Institute - Fruitland, Fruitland, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Saint Luke's Cancer Institute - Meridian, Meridian, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Saint Alphonsus Cancer Care Center-Nampa, Nampa, United States (Recruiting)
  • Site Public Contact
  • Tareq Al baghdadi (Principal Investigator)
• Saint Luke's Cancer Institute - Nampa, Nampa, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Kootenai Clinic Cancer Services - Post Falls, Post Falls, United States (Recruiting)
  • Site Public Contact
  • John M. Schallenkamp (Principal Investigator)
• Kootenai Clinic Cancer Services - Sandpoint, Sandpoint, United States (Recruiting)
  • Site Public Contact
  • John M. Schallenkamp (Principal Investigator)
• SIH Cancer Institute, Carterville, United States (Recruiting)
  • Site Public Contact
  • Bryan A. Faller (Principal Investigator)
• John H Stroger Jr Hospital of Cook County, Chicago, United States (Suspended)
• University of Illinois, Chicago, United States (Active not recruiting)
• Carle at The Riverfront, Danville, United States (Recruiting)
  • Site Public Contact
  • Maria T. Grosse-Perdekamp (Principal Investigator)
• Cancer Care Specialists of Illinois - Decatur, Decatur, United States (Recruiting)
  • Site Public Contact
  • Bryan A. Faller (Principal Investigator)
• Decatur Memorial Hospital, Decatur, United States (Recruiting)
  • Site Public Contact
  • Bryan A. Faller (Principal Investigator)
• Carle Physician Group-Effingham, Effingham, United States (Recruiting)
  • Site Public Contact
  • Maria T. Grosse-Perdekamp (Principal Investigator)
• Crossroads Cancer Center, Effingham, United States (Recruiting)
  • Site Public Contact
  • Bryan A. Faller (Principal Investigator)
• NorthShore University HealthSystem-Evanston Hospital, Evanston, United States (Recruiting)
  • Site Public Contact
  • Mary T. Jenkins Vogel (Principal Investigator)
• NorthShore University HealthSystem-Glenbrook Hospital, Glenview, United States (Recruiting)
  • Site Public Contact
  • Mary T. Jenkins Vogel (Principal Investigator)
• NorthShore University HealthSystem-Highland Park Hospital, Highland Park, United States (Recruiting)
  • Site Public Contact
  • Mary T. Jenkins Vogel (Principal Investigator)
• Carle Physician Group-Mattoon/Charleston, Mattoon, United States (Recruiting)
  • Site Public Contact
  • Maria T. Grosse-Perdekamp (Principal Investigator)
• Carle BroMenn Medical Center, Normal, United States (Recruiting)
  • Site Public Contact
  • Maria T. Grosse-Perdekamp (Principal Investigator)
• Carle Cancer Institute Normal, Normal, United States (Recruiting)
  • Site Public Contact
  • Maria T. Grosse-Perdekamp (Principal Investigator)
• Cancer Care Center of O'Fallon, O'Fallon, United States (Recruiting)
  • Site Public Contact
  • Bryan A. Faller (Principal Investigator)
• Mercyhealth Cancer Institute - Rockford, Rockford, United States (Recruiting)
  • Site Public Contact
  • Mayur Narkhede (Principal Investigator)
• Southern Illinois University School of Medicine, Springfield, United States (Recruiting)
  • Site Public Contact
  • Bryan A. Faller (Principal Investigator)
• Springfield Clinic, Springfield, United States (Recruiting)
  • Site Public Contact
  • Bryan A. Faller (Principal Investigator)
• Springfield Memorial Hospital, Springfield, United States (Recruiting)
  • Site Public Contact
  • Bryan A. Faller (Principal Investigator)
• Carle Cancer Center, Urbana, United States (Recruiting)
  • Site Public Contact
  • Maria T. Grosse-Perdekamp (Principal Investigator)
• Woodland Cancer Care Center, Michigan City, United States (Recruiting)
  • Site Public Contact
  • William H. Bae (Principal Investigator)
• UI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny, United States (Recruiting)
  • Site Public Contact
  • Seema Harichand-Herdt (Principal Investigator)
• UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines, United States (Recruiting)
  • Site Public Contact
  • Seema Harichand-Herdt (Principal Investigator)
• UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines, United States (Recruiting)
  • Site Public Contact
  • Seema Harichand-Herdt (Principal Investigator)

And 144 other sites.

Study Officials

• Haider S Mahdi (Principal Investigator) — NRG Oncology