WO44263: INAVO122 - Inavolisib in HER2+ Breast Cancer
Research type
Research Study
Full title
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB IN COMBINATION WITH PHESGO VERSUS PLACEBO IN COMBINATION WITH PHESGO AS MAINTENANCE THERAPY AFTER FIRST LINE INDUCTION THERAPY IN PARTICIPANTS WITH PIK3CA‑MUTATED HER2‑POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
IRAS ID
1007575
Contact name
Rachel Tedds
Contact email
Sponsor organisation
F Hoffmann La Roche AG
Research summary
Breast cancer is the most commonly diagnosed cancer in women. HER2-positive breast cancer is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which accounts for 15-20% of all breast cancers.
For most patients, standard treatment for HER2-positive cancer that has spread may include a treatment called Phesgo.
25-30% of these patients have a PIK3CA gene mutation, which has been identified as a key factor for treatments not being successful and therefore a poorer chance of survival. The PIK3CA gene is involved in a signal that cancer cells commonly use to grow and multiply, called the PI3K pathway.
Inavolisib blocks the PI3K pathway. Inavolisib is an experimental drug and has not been approved for the treatment of HER2-positive cancer that has spread, however clinical studies have demonstrated significant improvements in survival with the addition of treatments like Phesgo and support giving Inavolisib to patients whose breast cancer carries the PIK3CA gene mutation.
The purpose of this study is to assess how effective and safe the combination of inavolisib plus Phesgo is compared with placebo (treatment that looks like the inavolisib but has no affect) plus Phesgo, in participants with previously untreated PIK3CA mutated, HER2-positive cancer that has spread.Approximately 230 participants will take part in the study worldwide.
The total length of the study will be approximately 111 months, which is around 9 years.
The study is sponsored by F. Hoffman La Roche.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0091
Date of REC Opinion
25 Sep 2023
REC opinion
Further Information Favourable Opinion