Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

August 31, 2022

Primary Completion Date

December 31, 2027

Study Completion Date

January 31, 2028

Conditions
Metastatic Breast CancerER-positive Breast CancerHER2-negative Breast CancerBreast CancerLocally Advanced Breast Cancer
Interventions
DRUG

Palazestrant

Complete estrogen receptor antagonist (CERAN)

DRUG

Ribociclib

All subjects in Treatment Group 1 will receive palazestrant in combination with ribociclib.

DRUG

Alpelisib

All subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib.

DRUG

Everolimus

All subjects in Treatment Group 3 will receive palazestrant in combination with everolimus.

DRUG

Atirmociclib

All subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib.

Trial Locations (16)

2109

RECRUITING

Macquarie Health, Sydney

6009

RECRUITING

Breast Cancer Research Center- Western Australia, Nedlands

10029

RECRUITING

Ichan School of Medicine at Mount Sinai, New York

28204

RECRUITING

Atrium Health Levine Cancer Institute, Charlotte

32804

RECRUITING

Advent Health Hematology and Oncology, Orlando

37232

RECRUITING

Henry-Joyce Cancer Clinic, The Vanderbilt Clinic, Nashville

48126

RECRUITING

Henry Ford Health, Detroit

52242

RECRUITING

University of Iowa, Iowa City

55455

RECRUITING

Regents of the University of Minnesota, Minneapolis

63110

RECRUITING

Washington University, School of Medicine, St Louis

77030

RECRUITING

MD Anderson Cancer Center, Houston

80045

RECRUITING

University of Colorado Cancer Center, Aurora

85234

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

94158

RECRUITING

University of California San Francisco Health, San Francisco

98405

RECRUITING

Northwest Medical Specialties, Tacoma

02215

RECRUITING

Dana Farber Cancer Institute, Boston

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

Pfizer

INDUSTRY

lead

Olema Pharmaceuticals, Inc.

INDUSTRY