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Purpose

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmed diagnosis of HR+/HER2- breast cancer - Metastatic or locally advanced disease not amenable to curative therapy - Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen - Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal - Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test) - Consent to provide fresh or archival tumor tissue specimen - Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered 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 - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Life expectancy of > 6 months - Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Exclusion Criteria

  • Metaplastic breast cancer - Any history of leptomeningeal disease or carcinomatous meningitis - Any prior systemic therapy for metastatic breast cancer - Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months - Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway - Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes - Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible - Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period - Symptomatic active lung disease, or requiring daily supplemental oxygen - History of inflammatory bowel disease or active bowel inflammation - Anti-cancer therapy within 2 weeks before study entry - Investigational drug(s) within 4 weeks before randomization - Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation - Chronic corticosteroid therapy or immunosuppressants - Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment - Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Inavolisib + Palbociclib + Fulvestrant 		Participants will receive inavolisib, palbociclib, and fulvestrant.
  • Drug: Inavolisib
    Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.
    Other names:
    • GDC-0077
  • Drug: Palbociclib
    Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
  • Drug: Fulvestrant
    Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
Placebo Comparator
Placebo + Palbociclib + Fulvestrant 		Participants will receive placebo, palbociclib, and fulvestrant.
  • Drug: Placebo
    Participants will receive oral placebo on Days 1-28 of each 28-day cycle.
  • Drug: Palbociclib
    Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
  • Drug: Fulvestrant
    Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.

More Details

Status
Active, not recruiting
Sponsor
Hoffmann-La Roche

Study Contact

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.