NCT04872608

A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer

ctDNA-guided Adaptive Therapy Escalation in ER+ MBC: A Phase 1b Study With Letrozole, Palbociclib and Onapristone ER

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to find out whether the study drug onapristone ER, combined with the standard treatment for your cancer (letrozole and palbociclib), is a safe treatment for people who have metastatic or unresectable ER+/PR+/HER2- breast cancer. The researchers will test different doses of the study drug to find the highest dose that causes few or mild side effects.

Conditions

• Metastatic Breast Cancer
• Unresectable Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole will be given daily on days 1-28.
DRUG	Palbociclib	Palbociclib will be given daily on days 1-21 and held on days 22-28, as per standard FDA-approved dosing guidelines.
DRUG	Onapristone ER	Onapristone will be given daily on days 1-28.

Timeline

• Start date: 2021-09-09
• Primary completion: 2023-04-25
• Completion: 2023-04-25
• First posted: 2021-05-04
• Last updated: 2023-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study