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To Study the Effect of Inavolisib in Combination with Fulvestrant in Participants with Breast Cancer
EU CTIS ID: 2025-522805-39-00
What this study is testing
To evaluate the efficacy and safety of inavolisib 9 mg once a day (QD) in combination with fulvestrant compared with inavolisib 6 mg QD in combination with fulvestrant
- Therapeutic exploratory (Phase II)
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
- Documented ER+ or PR+ tumor, per ASCO/CAP guidelines
- Documented HER2-negative tumor, per ASCO/CAP guidelines
- Disease progression during or after treatment with a combination of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) and endocrine therapy (ET) in the metastatic setting – Participants must have received no more than one prior line of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) – Participants with evaluable bone-only disease are not eligible; disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible
- Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated (e.g., participants with visceral crisis) at time of entry into the study, as per national or local treatment guidelines
- Confirmation of biomarker eligibility: presence of ≥ 1 study-eligible PIK3CA mutation
You likely can't join if
- Metaplastic breast cancer
- Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
- Type 1 diabetes, or Type 2 diabetes requiring ongoing systemic therapy
- Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
- Symptomatic active lung disease, including pneumonitis
- Requirement for daily supplemental oxygen
See the full eligibility criteria
- Documented ER+ or PR+ tumor, per ASCO/CAP guidelines
- Documented HER2-negative tumor, per ASCO/CAP guidelines
- Disease progression during or after treatment with a combination of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) and endocrine therapy (ET) in the metastatic setting – Participants must have received no more than one prior line of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) – Participants with evaluable bone-only disease are not eligible; disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible
- Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated (e.g., participants with visceral crisis) at time of entry into the study, as per national or local treatment guidelines
- Confirmation of biomarker eligibility: presence of ≥ 1 study-eligible PIK3CA mutation
- Life expectancy of > 6 months
- Ability, in the investigator’s judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes
- Metaplastic breast cancer
- Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
- Type 1 diabetes, or Type 2 diabetes requiring ongoing systemic therapy
- Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
- Symptomatic active lung disease, including pneumonitis
- Requirement for daily supplemental oxygen
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Mexico
- Turkey
- United Kingdom
- Australia
- 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 United States; Mexico; Turkey; United Kingdom; Australia; Argentina. 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.