Spots Global Cancer Trial Database for Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Official Title: A Phase II Study of Neratinib Alone and in Combination With Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Study ID: NCT01670877
Conditions
Study Description
Brief Summary: This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.
Detailed Description: Overexpression of HER2 due to gene amplification is an established therapeutic target in breast cancer for which multiple HER2 targeted drugs are now available. However, the majority of breast cancers are without HER2 overexpression/non-amplified and not currently eligible to receive HER2 targeted drugs. Advances in tumor genome sequencing technology led to the identification of recurrent HER2 mutations (HER2mut) in approximately 2% of HER2 non-amplified primary breast cancers, and 3-5% of metastatic tumors. Importantly, tumor cells harboring HER2mut are sensitive to the anti-tumor effects of HER2-targeted agents in preclinical models, especially neratinib, a potent irreversible pan-HER inhibitor. However, neratinib monotherapy has demonstrated only modest single agent activity in HER2mut,, non-amplified metastatic breast cancer (MBC). Based on the hypothesis that the combination of neratinib and fulvestrant will be more effective than neratinib alone in ER+/HER2mut, non-amplified MBC the investigators conducted a single arm phase II study of neratinib plus fulvestrant with 2 cohorts, fulvestrant (FUL)-treated and FUL-naïve, for patients with ER+/HER2mut, non-amplified MBC to assess the anti-tumor effects of this combination. An exploratory ER-negative (ER-) HER2mut cohort was also included for the efficacy of neratinib monotherapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Cancer Center, Birmingham, Alabama, United States
Mayo Clinic, Phoenix, Arizona, United States
University of Southern California Keck School of Medicine, Los Angeles, California, United States
Stanford Medicine Cancer Institute, Stanford, California, United States
University of Miami Hospital and Clinics, Miami, Florida, United States
Northwestern University - Feinberg School of Medicine, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Harvard University, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
St. Luke's Cancer Institute, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of North Carolina at Chapel Hill (Lineberger Comprehensive Cancer Center), Chapel Hill, North Carolina, United States
Duke Cancer Institute at Duke University Medical Center, Durham, North Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Baylor College of Medicine, Houston, Texas, United States
BC Cancer Agency, Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Contact Details
Name: Cynthia Ma, M.D., Ph.D
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
