Gedatolisib for Breast Cancer

Phase-Based Progress Estimates
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, INBreast CancerGedatolisib - Drug
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new combination of drugs to treat advanced breast cancer that is negative for HER2 and either triple negative or BRCA1/2 positive.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 24 Months

16 Weeks
Clinical Benefit Rate (CBR) at 16 weeks
24 Months
Duration of Response (DOR)
Investigator-assessed Progression-Free Survival (PFS) (Cohort B only)
Objective Response Rate (Cohort B only)
Objective Response Rate (ORR) (Phase II)
Overall Survival
Rates of Adverse Events
28 days
Maximum Tolerated Dose (MTD) of talazoparib in combination with gedatolisib (Phase I)

Trial Safety

Trial Design

1 Treatment Group

Talazoparib + Gedatolisib
1 of 1

Experimental Treatment

37 Total Participants · 1 Treatment Group

Primary Treatment: Gedatolisib · No Placebo Group · Phase 1 & 2

Talazoparib + GedatolisibExperimental Group · 2 Interventions: Gedatolisib, Talazoparib · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Celcuity, Inc.Industry Sponsor
6 Previous Clinical Trials
950 Total Patients Enrolled
3 Trials studying Breast Cancer
898 Patients Enrolled for Breast Cancer
Kari WisinskiLead Sponsor
2 Previous Clinical Trials
81 Total Patients Enrolled
PfizerIndustry Sponsor
4,352 Previous Clinical Trials
7,172,001 Total Patients Enrolled
102 Trials studying Breast Cancer
29,965 Patients Enrolled for Breast Cancer
Kari Wisinski, MD5.01 ReviewsPrincipal Investigator - University of Wisconsin, Madison
Big Ten Cancer Research Consortium
6 Previous Clinical Trials
132 Total Patients Enrolled
2 Trials studying Breast Cancer
35 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years old or older.
You have a disease that can be measured or evaluated by medical tests.
You have been diagnosed with breast cancer that has spread to other parts of your body or cannot be removed by surgery.
Your most recent tumor biopsy must show low levels of ER/PR proteins, and previous biopsies cannot show high levels of these proteins.
You have advanced triple negative breast cancer, and your genetic testing for BRCA gene mutations either came back negative or the results are unknown. Variants that are unclear in the BRCA 1/2 genes should be considered negative.
You have advanced breast cancer that does not respond to HER2 treatment and have a specific genetic mutation called BRCA1 or BRCA2.
You need to meet the requirements for either group A or group B in the initial stage of the study.
If your HER2 test results show negative according to the ASCO/CAP guidelines, or HER2 positive with a score of 0 or 1+ on IHC, or 2+ with a negative ISH, you will not be eligible.
HER2 is considered negative if it meets specific guidelines for testing, or if it is determined to be 0 or 1+ on a certain type of test called IHC, or 2+ on IHC with negative ISH.
People from different backgrounds, such as different races, ethnicities, genders, and age groups, will be included in the study so that the results can apply to a wider population.

Frequently Asked Questions

Are patients currently being recruited for this trial?

"Yes, this research is currently looking for volunteers to enroll. The trial was announced on April 17th, 2019 and has since been updated January 18th of this year." - Anonymous Online Contributor

Unverified Answer

Are there any other Gedatolisib studies that have been completed?

"There are currently 61 clinical trials underway for Gedatolisib. 3 of those trials are in the final stage, Phase 3. Most of the research is being conducted in Kashiwa, Chiba; however, there are 2322 total locations running Gedatolisib trials." - Anonymous Online Contributor

Unverified Answer

What are the primary objectives of this research?

"According to the study's sponsor, Pfizer, the primary objective of this 24-month long trial is to establish the Maximum Tolerated Dose (MTD) of talazoparib when used in combination with gedatolisib. Additionally, this clinical study will measure secondary outcomes including the Objective Response Rate (defined as confirmed complete response + confirmed partial response according to RECIST 1.1 criteria), Clinical Benefit Rate (CBR; defined as sum of confirmed complete plus partial and measurable disease responses plus stable disease at 16 weeks), and Overall Survival rate." - Anonymous Online Contributor

Unverified Answer

Are there different versions of this experiment being conducted in various locations?

"5 sites are currently running this study, with locations in Chicago, Iowa City and Madison. To reduce travel for participants, it is encouraged to enroll at the clinical trial site nearest you." - Anonymous Online Contributor

Unverified Answer

How many subjects are involved in this research project?

"In order to run this trial, 54 patients who meet specific inclusion criteria must be recruited. The clinical trial is being administered by Pfizer at various locations, such as Northwestern University Feinberg School of Medicine in Chicago, Illinois and University of Iowa Hospital and Clinics in Iowa City, Iowa." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.