WO43919 - INAVO121 in HR+ Metastatic Breast Cancer
Research type
Research Study
Full title
A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS FULVESTRANT VERSUS ALPELISIB PLUS FULVESTRANT IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE, PIK3CA MUTATED, LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO PROGRESSED DURING OR AFTER CDK4/6 INHIBITOR AND ENDOCRINE COMBINATION THERAPY
IRAS ID
1007071
Contact name
Rachel Tedds
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2022-000454-28
Research summary
Breast cancer is the most commonly diagnosed cancer in women. Hormone receptor (HR)-positive, HER2-negative breast cancer accounts for 60%–70% of all breast cancers.
For most patients, endocrine therapy alone or in combination with a targeted therapy is the treatment of choice in the metastatic setting.
Not all HR-positive breast cancers respond optimally to endocrine therapy. Multiple mechanisms may lead to primary and/or secondary resistance to endocrine therapy. The addition of targeted therapies to endocrine therapy may be able to overcome mechanisms of resistance to endocrine therapy.
Inavolisib is an experimental drug and has not been approved for the treatment of HR-positive advanced or metastatic breast cancer. Inavolisib blocks a signal that cancer cells commonly use to grow and multiply. This signal is called the PI3K pathway. Clinical studies have demonstrated significant improvements in progression-free survival with the addition of targeted therapies to endocrine therapy and support giving Inavolisib to patients whose breast cancer carries a mutation in the gene that controls the PI3K pathway, this gene is called PIK3CA.
Because standard treatment for this type of cancer outside of a clinical trial may include a targeted therapy, such as Alpelisib (a PI3K pathway inhibitor that has been approved in this setting already) in combination with an endocrine therapy (fulvestrant), this study will test the combination of Inavolisib and fulvestrant compared with Alpelisib and fulvestrant.
This study will evaluate the efficacy, safety, pharmacokinetics of Inavolisib and fulvestrant compared with Alpelisib and fulvestrant. The patient population will be those with PIK3CA-mutant, HR-positive, HER2-negative locally advanced/ metastatic breast cancer whose disease has progressed during/after their first treatment for locally advanced/ metastatic disease.
Approx 400 participants will take part in the study over 7 years.REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0105
Date of REC Opinion
5 Apr 2023
REC opinion
Further Information Favourable Opinion