Breast Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Interventions
DRUGInavolisib
Participants will receive Inavolisib as per the schedule given in the protocol.
DRUGFulvestrant
Participants will receive Fulvestrant as per the schedule given in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting * Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) * Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated 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
Exclusion criteria
* Metaplastic breast cancer * Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting * Requirement for daily supplemental oxygen * Symptomatic active lung disease, including pneumonitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Objective Response Rate (ORR) | Up to approximately 2 years |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to approximately 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR) | Up to approximately 2 years |
| Time to Response (TTR) | Up to approximately 2 years |
| Progression-free Survival (PFS) | Up to approximately 2 years |
| Percentage of Participants With Treatment Discontinuation due to Adverse Events | Up to approximately 2 years |
| Number of Participants Reporting Presence, Frequency, Severity and/or Degree of Interference With Daily Activities of Symptomatic Treatment Toxicities as Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to approximately 2 years |
| Percentage of Participants Reporting Presence and Frequency of Selected Hyperglycemia Symptoms as Assessed by European Organisation for Research and Treatment of Cancer (EORTC) IL382 | Up to approximately 2 years |
| Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item General Population, Question 5 (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire | Up to approximately 2 years |
| Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE | Baseline, Up to approximately 2 years |
| Change from Baseline in Selected Hyperglycemia Symptoms as Assessed by EORTC IL382 | Baseline, Up to approximately 2 years |
| Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item | Baseline, Up to approximately 2 years |
Countries
Argentina, Australia, Belgium, Mexico, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTReference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed