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A Phase I/II, single arm, open-label study of Ribociclib in Combination with Everolimus + Exemestane in the Treatment of Men and Postmeopausal Women with HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase I/II, single arm, open-label study of Ribociclib in Combination with Everolimus + Exemestane in the Treatment of Men and Postmeopausal Women with HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor
 
Region Sponsors
Hawaii
Norvartis
 
Acronym KP IRB No.
TRINITI-1 STUDY00000510
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
 
Purpose
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
 
Detailed Description
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.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • 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
 
Exclusion Criteria
  • 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

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • Moanalua Medical Center and Clinic
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Carney, MD
Contact Information:
- Shelley Clark, RN
-Moanalua Medical Center and Clinic


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