Investigational Group for erbB-2 Receptor

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
erbB-2 Receptor+4 More
Fulvestrant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a new combination therapy of ribociclib and ET is effective and safe in treating patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

Eligible Conditions
  • Hormone Receptor-positive Breast Cancer
  • erbB-2 Receptor
  • Locoregional Recurrence

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 3 years

3 months
Assess adverse events
3 years
Distant Metastasis-Free Survival
Overall Survival (OS)
Recurrence Free Survival (RFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Investigational Group
1 of 1

Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: Investigational Group · No Placebo Group · Phase 2

Investigational GroupExperimental Group · 5 Interventions: Fulvestrant, Anastrozole, Ribociclib, Letrozole, Exemestane · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3810
Anastrozole
2019
Completed Phase 4
~10260
Ribociclib
2016
Completed Phase 2
~4890
Letrozole
2005
Completed Phase 4
~4490
Exemestane
2003
Completed Phase 4
~7870

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Oana DanciuLead Sponsor
Novartis PharmaceuticalsIndustry Sponsor
2,694 Previous Clinical Trials
3,522,859 Total Patients Enrolled
Oana Danciu, MDPrincipal InvestigatorUniversity of Illinois at Chicago
1 Previous Clinical Trials
12 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible to donate blood or tissue if you are 18 years or older.
You must be at least 18 years old to participate in this study.
You have estrogen-receptor positive and/or progesterone receptor positive breast cancer.
Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+.
You have had a menopause for at least 12 months, but not for the last 12 months
You are not able to perform any of the following activities: walk, talk, or push a wheelchair.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: November 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.