Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Hope Rugo

Description

Summary

The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor

Official Title

A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor

Details

The purpose of the phase I dose escalation part of this study is to estimate the MTD(s) and/or identify the RP2D of the combination treatment of ribociclib+ everolimus + exemestane when dosed continuously in adult men and postmenopausal women with HR+ HER2-negative advanced breast cancer resistant to the non-steroidal aromatase inhibitors, fulvestrant or tamoxifen.

The purpose of the phase II portion of this trial will be to evaluate the anti-tumor activity of exemestane, everolimus and ribociclib triplet following progression on a CDK 4/6 inhibitor. This part of the study will be conducted using a Simon's optimal two-stage design.

Keywords

Breast Cancer HR-positive HER2-negative Advanced breast cancer LEE011 ribociclib everolimus Afinitor exemestane Aromasin CDK CDK4 CDK6 CDK4/6 CDK4/6 inhibitor Phase III ER-positive PR-positive Postmenopausal Breast Neoplasms Sirolimus ribociclib + everolimus + exemestane

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adult men and women
  • Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer
  • Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.
  • ECOG Performance Status 0 - 1
  • Disease refractory to either, AI, tamoxifen or fulvestrant
  • Previously treated on any CDK 4/6 inhibitor.
  • Patient has adequate bone marrow and organ function.

You CAN'T join if...

  • Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
  • Patient has received more than one line of chemotherapy for advanced disease.
  • Previous treatment with mTOR inhibitors, or exemestane for advanced disease.
  • Progressed on more than one CDK 4/6 inhibitor
  • Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.
  • Clinically significant, uncontrolled heart disease and/or recent cardiac events.

Locations

  • University of California San Francisco Comprehensive Cancer Center
    San Francisco California 94115 United States
  • Central Coast Medical Oncology Corporation Onc Dept
    Santa Maria California 93454 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02732119
Phase
Phase 1/2
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated