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A Study to Assess safety and Effectiveness of the Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Partcipants with Advanced Breast Cancer
EU CTIS ID: 2024-516162-11-00
What this study is testing
To evaluate the efficacy of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared with placebo plus a CDK4/6i and letrozole with respect to time from randomization to the first occurrence of disease progression
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- De-novo hormone receptor-positive (HR +) , HER2- advanced breast cancer (ABC), or, alternatively, relapsed HR + , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy – If a CDK4/6i was included as part of that early breast cancer treatment, progression must not have occurred during or within 1 year of last receipt of the CDK4/6i
- Confirmation of biomarker eligibility: valid results from either central testing of blood or pre-existing local testing of blood or tumor tissue documenting the presence of a study-eligible PIK3CA-mutation.
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Men or women of postmenopausal or premenopausal/perimenopausal status
- For men (and women of pre-/peri-menopausal status: willingness to undergo and maintain treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy for the duration of study treatment
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
You likely can't join if
- Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
- Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., patients with visceral crisis)
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Inability or unwillingness to swallow pills
- Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- History of malignancy within 5 years prior to consent, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Switzerland
- United Kingdom
- China
- Taiwan
- Canada
- Mexico
- Japan
- Korea, Republic of
- United States
- Brazil
- Turkey
- South Africa
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Switzerland; United Kingdom; China; Taiwan; Canada and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.