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



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


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.


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


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.


  • 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

Lead Scientist

  • Hope Rugo
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.


in progress, not accepting new patients
Start Date
Completion Date
Novartis Pharmaceuticals
Phase 1/2
Study Type
Last Updated