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A Phase 3, Open-Label, Randomized, 2 Part Study Comparing Gedatolisib in Combination with Palbociclib & Fulvestrant to SoC Therapies in Patients with HR+ HER2- Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor with Non-Steroidal AI Therapy

Clinical Trial Details

This clinical trial is for adult participants who have breast cancer that is advanced or that has spread to other parts of the body.
   
The purpose of this study is to evaluate the safety and effectiveness of a new drug called gedatolisib when combined with other cancer drugs, compared to the standard of care. The standard of care is a drug or drug combination that is usually given to patients with breast cancer. Gedatolisib, which is intended to slow or stop the growth of cancer, is not yet approved by the United States Food and Drug Administration (FDA).

During the screening period, the study doctor will run tests to determine if a participant’s cancer has a genetic variation (difference) in a gene called PIK3CA. This will determine which part of the study they enter. 

Participants will be randomized into one of the study parts, which means they are assigned by chance, like flipping a coin. Depending on the part, participants will receive one of the following study drugs, or a combination of them: gedatolisib, palbociclib, fulvestrant, and/or alpelisib. Palbociclib, fulvestrant, and alpelisib are considered standard of care treatments for breast cancer. All the study drugs and study drug combinations used in this study are intended to decrease the growth and survival of cancer cells. 

The study team will discuss the drug or combination of drugs each participant will be receiving as well as the dosing schedule. The study drugs are given as follows:

  • Gedatolisib will be injected through a vein (IV) over approximately 30 minutes   
  • Fulvestrant will be injected into participant’s buttock muscles. Each dose of fulvestrant will require 2 injections (1 per buttock muscle) lasting 1 to 2 minutes each.    
  • Palbociclib will be taken by mouth in tablet form
  • Alpelisib will be taken by mouth in tablet form

The duration of the study and the number of study visits will depend on participants’ response to the study drug regimen. Total participation should not exceed 48 months.

Key Eligibility: 
  1. Adults with a confirmed diagnosis of metastatic or locally advanced breast cancer
  2. Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
  3. Women who are postmenopausal, or pre/perimenopausal women with medically-induced menopause
  4. Male participants must use a medically effective contraceptive method from screening until 1 year after the last dose of study treatment

Detailed eligibility reviewed when participant contacts the study team.

 

 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Jessica Wilk
(646) 697-0361
jsw9043@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2209025236

ClinicalTrials.gov:

NCT05501886

Sponsor:

CELC-G-301

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease