WO41554 A Study of GDC 0077 in patients with HR-Positive Breast Cancer
Research type
Research Study
Full title
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN PATIENTS WITH PIK3CA MUTANT, HORMONE RECEPTOR POSITIVE, HER2 NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST
IRAS ID
273402
Contact name
Nicholas Turner
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2019-002455-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 2 months, 4 days
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.GDC-0077 is an experimental drug and has not been approved for the treatment of HR-positive advanced or metastatic breast cancer. GDC-0077 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 GDC-0077 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 (palbociclib) in combination with an endocrine therapy (fulvestrant), this study will test the combination of GDC-0077 with palbociclib and fulvestrant.
This study will evaluate the efficacy, safety, and pharmacokinetics of GDC-0077 in
combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant. The patient population will be those with PIK3CA-mutant, HR-positive, HER2-negative locally advanced or metastatic breast cancer whose disease has progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for locally advanced or metastatic disease.Approximately 400 participants will take part in the study worldwide.
The total length of the study will be approximately 6 years.
The study is sponsored by F. Hoffman La Roche
REC name
HSC REC A
REC reference
20/NI/0128
Date of REC Opinion
2 Nov 2020
REC opinion
Further Information Favourable Opinion