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A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS A CDK4/6 INHIBITOR AND LETROZOLE VERSUS PLACEBO PLUS A CDK4/6 INHIBITOR AND LETROZOLE IN PATIENTS WITH ENDOCRINE-SENSITIVE PIK3CA-MUTATED, HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER (WO45654)

Status: Recruiting

The purpose of this research is to test safety, efficacy and compare the effects of a combination therapy involving inavolisib plus a CDK4/6i (palbociclib) and letrozole versus placebo plus a CDK4/6i (palbociclib) and letrozole on patients with HR+, HER2- advanced breast cancer (ABC). In this study, you will get either inavolisib plus palbociclib and letrozole or placebo plus palbociclib and letrozole. A placebo looks like a drug but has no active ingredient.

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• women or men with confirmed breast cancer
• ER-positive and/or progesterone receptor-positive and HER2-negative tumor
• may not be able to do strenuous activity but able to walking and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding, or intend to become pregnant
• metaplastic breast cancer
• Type 2 diabetes requiring ongoing treatment; or any history of Type 1 diabetes
• inflammatory or infectious conditions in either eye
• active lung disease
• history of or active inflammatory bowel disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions:

Cancer

Keywords:

Clinics and Surgery Center (CSC), breast cancer

Study Contact: Douglas Yee - yeexx006@umn.edu
Principal Investigator: Douglas Yee, MD
Phase: PHASE3
IRB Number: STUDY00025543
See this study on ClinicalTrials.gov

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