INAVOLISIB for PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer|Advanced breast cancer|Metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- Documented ER+ or PR+ tumor, per ASCO/CAP guidelines\n- Documented HER2-negative tumor, per ASCO/CAP guidelines\n- 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\n- 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\n- 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\n- Confirmation of biomarker eligibility: presence of ≥ 1 study-eligible PIK3CA mutation\n- Life expectancy of > 6 months\n- Ability, in the investigator’s judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes"}

Exclusion criteria

• {"criterion_text":"- Metaplastic breast cancer\n- Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting\n- Type 1 diabetes, or Type 2 diabetes requiring ongoing systemic therapy\n- Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting\n- Symptomatic active lung disease, including pneumonitis\n- Requirement for daily supplemental oxygen"}

Primary endpoints

• {"endpoint_text":"- Confirmed Objective Response Rate (ORR), defined as the proportion of participants with a complete response or partial response on at least two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1","definition_or_measurement_approach":"Proportion of participants with complete or partial response on at least two consecutive occasions ≥4 weeks apart, assessed by investigator per RECIST v1.1"}
• {"endpoint_text":"- Incidence of key inavolisib-associated adverse events, including hyperglycemia, stomatitis/oral mucositis, and diarrhea.","definition_or_measurement_approach":"Incidence (frequency) of specified adverse events associated with inavolisib; specific measurement/collection method not further detailed in available metadata"}
• {"endpoint_text":"- Severity of key PI3K-inhibition associated adverse events, including hyperglycemia, stomatitis/oral mucositis, and diarrhea as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.","definition_or_measurement_approach":"Severity graded according to CTCAE v5.0"}

Secondary endpoints

• {"endpoint_text":"- DOR, duration of response, defined as the time from the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1","definition_or_measurement_approach":"Time from first confirmed objective response to disease progression or death, assessed by investigator per RECIST v1.1"}
• {"endpoint_text":"- TTR, time to response, defined as the time from randomization to first occurrence of a documented objective response as determined by the investigator according to RECIST v1.1","definition_or_measurement_approach":"Time from randomization to first documented objective response, per investigator assessment using RECIST v1.1"}
• {"endpoint_text":"- PFS, progression-free survival, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first)","definition_or_measurement_approach":"Time from randomization to disease progression (per investigator RECIST v1.1) or death"}
• {"endpoint_text":"- Incidence of treatment discontinuations due to adverse events","definition_or_measurement_approach":"Incidence (frequency) of treatment discontinuations where reason recorded as adverse event"}
• {"endpoint_text":"- Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in specified clinical laboratory tests (specific tests not listed in metadata)"}
• {"endpoint_text":"- Presence, frequency of occurrence, severity, and/or degree of interference with daily activities of symptomatic treatment toxicities (i.e., diarrhea, nausea, vomiting, decreased appetite, fatigue, mouth sores, and rash), as assessed through use of the National Cancer Institute Patient-Reported outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) instrument","definition_or_measurement_approach":"Patient-reported symptomatic toxicities assessed using the NCI PRO-CTCAE instrument"}
• {"endpoint_text":"- Presence and frequency of occurrence of selected hyperglycemia symptoms (i.e. increased thirst and frequent urination), as assessed through the European Organisation for Research and Treatment of Cancer (EORTC) IL382","definition_or_measurement_approach":"Patient-reported hyperglycemia symptoms assessed using EORTC IL382"}
• {"endpoint_text":"- Proportion of participants reporting each response option at each assessment timepoint by treatment arm for treatment side effect bother single-item General Population Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General questionnaire (FACT-G)","definition_or_measurement_approach":"Proportion reporting each response option on FACT-G GP5 item at each assessment timepoint by treatment arm"}
• {"endpoint_text":"- Change from baseline/worsening in symptomatic treatment toxicities and treatment side effect bother as assessed through use of the PRO-CTCAE, EORTC IL382, and FACT-G GP5 item, respectively","definition_or_measurement_approach":"Change from baseline or worsening assessed using PRO-CTCAE, EORTC IL382 and FACT-G GP5"}

Belgium

Earliest CTIS Part Ii Submission Date

12-12-2025

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

42

Number Of Sites

4

Number Of Participants

10

Spain

Earliest CTIS Part Ii Submission Date

17-10-2025

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

98

Number Of Sites

4

Number Of Participants

10

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

PPD Global Limited

Responsibilities

CRO

Third parties

• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Central lab, PIK3CA analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"PK analysis lab","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab, kits and shipment","organisation_type":"Pharmaceutical company"}