Study of TTC-352 in Patients With Metastatic Breast Cancer Progressing on Endocrine Therapy

Metastatic ER+ Breast Cancer Clinical Trial

Official title:
Phase 1 Study of TTC-352 in Patients With Metastatic Breast Cancer Progressing on Endocrine Therapy

Status Completed

Clinical Trial Summary

Phase1 study of TTC 352 for treatment of metastatic ER+ breast cancer.

Clinical Trial Description

This is open-label, accelerated dose escalation study of TTC 352, a selective human ER partial agonist for treatment of metastatic ER+ breast cancer in patients who received and progressed on at least two lines of endocrine therapy with one that included a CDK4/CDK6 inhibitor.

The primary objective of this study is to determine the maximum tolerated dose (MTD) of TTC-352 for the treatment of metastatic ER+ breast cancer progressing after endocrine therapy.

The maximum tolerated dose (MTD) of TTC-352 will be determined using initial single-patient cohort escalations until grade 2 toxicity, then expansion to a modified-Fibonacci dose-escalation 3+3 design. Patients enrolled at each dose escalation step must complete the first 28-day cycle of treatment without a dose-limiting toxicity (DLT), or be withdrawn because of a DLT, before additional patients may be enrolled for the next dose escalation step. The MTD dose level cohort will be expanded to a total of 9 patients, to further evaluate safety. In each cohort pharmacokinetics of TTC-352 will be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03201913
Study type	Interventional
Source	TTC Oncology, LLC
Contact
Status	Completed
Phase	Phase 1
Start date	December 11, 2017
Completion date	April 30, 2020

View Details