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Estrogen Receptor Antagonist
Fulvestrant + Neratinib In Breast Cancer (HER2-Signal Trial)
Boston, MA
Phase 2
Waitlist Available
Led By Aditya Bardia, MD,MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 33 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
This trial is designed to study if adding Neratinib to Fulvestrant can improve outcomes in patients with metastatic hormone receptor positive, HER2 negative breast cancer.
See full description
Eligible Conditions
- Metastatic Breast Cancer
- Breast Cancer
- Breast cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 33 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 33 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rates (ORR)
Secondary study objectives
CELsignia score and CB
CELsignia score and Objective Response
CELsignia score and Progression Free Survival
+7 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NERATINIB + FULVESTRANTExperimental Treatment2 Interventions
After the screening procedures confirm participation in the research study.
- Each Cycle = 28 days
* Neratinib (oral, once daily)
* Fulvestrant, injection, on 2 days for cycle 1, then one time per cycle thereafter
Find a Location
Closest Location:Massachusetts General Hospital· Boston, MA
Who is running the clinical trial?
Celcuity, Inc.Industry Sponsor
6 Previous Clinical Trials
916 Total Patients Enrolled
3 Trials studying Breast Cancer
852 Patients Enrolled for Breast Cancer
Celcuity IncIndustry Sponsor
8 Previous Clinical Trials
1,644 Total Patients Enrolled
4 Trials studying Breast Cancer
1,526 Patients Enrolled for Breast Cancer
Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
10,074 Total Patients Enrolled
14 Trials studying Breast Cancer
4,333 Patients Enrolled for Breast Cancer
Massachusetts General HospitalLead Sponsor
3,050 Previous Clinical Trials
13,417,745 Total Patients Enrolled
80 Trials studying Breast Cancer
131,195 Patients Enrolled for Breast Cancer
Aditya Bardia, MD,MPHPrincipal InvestigatorMassachusetts General Hospital