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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Inavolisib Dose A plus Fulvestrant 		Participants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection.
  • Drug: Inavolisib
    Participants will receive Inavolisib as per the schedule given in the protocol.
  • Drug: Fulvestrant
    Participants will receive Fulvestrant as per the schedule given in the protocol.
Experimental
Inavolisib Dose B plus Fulvestrant 		Participants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection.
  • Drug: Inavolisib
    Participants will receive Inavolisib as per the schedule given in the protocol.
  • Drug: Fulvestrant
    Participants will receive Fulvestrant as per the schedule given in the protocol.

Recruiting Locations

Los Angeles Cancer Network
Los Angeles 5368361, California 5332921 90017-4803

Astera Cancer Care East Brunswick
East Brunswick 5097402, New Jersey 5101760 08816

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: WO46063 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.