To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07368998
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inavolisib — DRUG
    Participants will receive Inavolisib as per the schedule given in the protocol.
  • Fulvestrant — DRUG
    Participants will receive Fulvestrant as per the schedule given in the protocol.

Study Details

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.

Key Dates

Start date
Feb 18, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2031
Completion
Oct 31, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inavolisib Dose A plus Fulvestrant
    Participants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection.
  • Experimental: Inavolisib Dose B plus Fulvestrant
    Participants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection.

Primary Outcome Measure

Percentage of Participants With Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts

  • Reference Study ID Number: WO46063 https://forpatients.roche.com/
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (2)

FacilityCityStateZIPSite coordinators
Los Angeles Cancer NetworkLos AngelesCalifornia90017-4803-
Astera Cancer Care East BrunswickEast BrunswickNew Jersey08816-

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Los Angeles Cancer Network· Los Angeles, CAAstera Cancer Care East Brunswick· East Brunswick, NJ

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