Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.

Disease Sites:

Breast

Staging:

Phase I/II

Age Group:

Adults

Therapies:

Hormonal Therapy, Mol. targeted/Immunotherapy/Biologics

Drugs:

Abemaciclib, Alpelisib (PIQRAY), Capivasertib, Elacestrant, Everolimus, Palbociclib, Ribociclib

Principal Investigator(s):

Rexer, Brent

Scope:

International

Participating Institutions:

Vanderbilt University

Open Date:

05-10-2024

Trial Type:

Treatment

Protocol ID:

VICC-DTBRE23166P

National Clinical Trial ID:

NCT05563220

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

ALL

Accepts Healthy Volunteers?:

false

Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Eligibility