To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Inavolisib
DrugParticipants will receive Inavolisib as per the schedule given in the protocol.
Fulvestrant
DrugParticipants will receive Fulvestrant as per the schedule given in the protocol.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Inavolisib Dose A plus FulvestrantExperimental treatment 2 interventions
Group B: Inavolisib Dose B plus FulvestrantExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants With Objective Response Rate (ORR)
Time frame
Up to approximately 2 years2
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Duration of Response (DOR)
Time frame
Up to approximately 2 years2
Time to Response (TTR)
Time frame
Up to approximately 2 years3
Progression-free Survival (PFS)
Time frame
Up to approximately 2 years4
Percentage of Participants With Treatment Discontinuation due to Adverse Events
Time frame
Up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov