Arm A - Patients Lacking PIK3CA Mutations (WT) for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Breast Cancer+1 More
Fulvestrant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Approximately 48 months

Approximately 48 months
Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Day 30
EuroQol 5 in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Patient-Reported Outcomes in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Breast
Quality of Life (QOL)Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI) Questions in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Month 48
Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Month 48
Adverse Events
Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

6 Treatment Groups

Arm C - Patients Lacking PIK3CA Mutations (WT)
1 of 6
Arm E - Patients with PIK3CA Mutation (MT)
1 of 6
Arm A - Patients Lacking PIK3CA Mutations (WT)
1 of 6
Arm F - Patients with PIK3CA Mutation (MT)
1 of 6
Arm D - Patients with PIK3CA Mutation (MT)
1 of 6
Arm B - Patients Lacking PIK3CA Mutations (WT)
1 of 6

Active Control

Experimental Treatment

701 Total Participants · 6 Treatment Groups

Primary Treatment: Arm A - Patients Lacking PIK3CA Mutations (WT) · No Placebo Group · Phase 3

Arm A - Patients Lacking PIK3CA Mutations (WT)Experimental Group · 3 Interventions: Fulvestrant, Gedatolisib, Palbociclib · Intervention Types: Drug, Drug, Drug
Arm F - Patients with PIK3CA Mutation (MT)Experimental Group · 2 Interventions: Fulvestrant, Gedatolisib · Intervention Types: Drug, Drug
Arm D - Patients with PIK3CA Mutation (MT)Experimental Group · 3 Interventions: Fulvestrant, Gedatolisib, Palbociclib · Intervention Types: Drug, Drug, Drug
Arm B - Patients Lacking PIK3CA Mutations (WT)Experimental Group · 2 Interventions: Fulvestrant, Gedatolisib · Intervention Types: Drug, Drug
Arm C - Patients Lacking PIK3CA Mutations (WT)
Drug
ActiveComparator Group · 1 Intervention: Fulvestrant · Intervention Types: Drug
Arm E - Patients with PIK3CA Mutation (MT)ActiveComparator Group · 2 Interventions: Fulvestrant, Alpelisib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3810
Gedatolisib
2018
Completed Phase 1
~160
Palbociclib
2017
Completed Phase 3
~4630

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 48 months

Who is running the clinical trial?

Celcuity, Inc.Lead Sponsor
5 Previous Clinical Trials
249 Total Patients Enrolled
2 Trials studying Breast Cancer
197 Patients Enrolled for Breast Cancer
Nadene ZackStudy DirectorCelcuity, Inc.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have HER2 IHC negative as per ASCO-CAP 2018 guideline.
Female subjects who are not surgically sterile must use a medically-effective contraceptive method from screening until 1 year after the last dose of study treatment.
You have a confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per ASCO-CAP guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards.
You have adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status.
You have radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment.
You have a performance status of 0-1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 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.

Who else is applying?

What state do they live in?
Michigan100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Virginia Cancer Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%