RecruitingPhase 3

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares how well inavolisib plus fulvestrant and alpelisib plus fulvestrant work and how safe they are. It is for people with advanced breast cancer that is HR-positive, HER2-negative, and has a PIK3CA gene change, whose cancer grew during or after a CDK4/6-blocking drug plus hormone therapy. The main study is now full.

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have breast cancer that has spread nearby or to other parts of the body and cannot be cured with surgery or radiation.
  • Tests must show HR-positive cancer (uses hormones to grow), HER2-negative cancer (does not have high levels of HER2 protein), and a required PIK3CA gene change.
  • Cancer grew during or after a CDK4/6-blocking drug plus hormone therapy. Have had no more than 2 courses of drug treatment for cancer that spread, including no more than 1 course of chemotherapy.
  • Cancer can be measured or checked using the study’s rules.
  • Hormone-based treatment is recommended, and chemotherapy is not needed when joining.
  • Can do all or most self-care and are out of bed or a chair for more than half of waking hours.
  • Are expected to live more than 6 months and have blood counts and organ function that meet study requirements.
  • Men and women who have not fully gone through menopause must start an LHRH drug, which lowers sex hormones, at least 2 weeks before study treatment.

Who can't join

  • Have metaplastic breast cancer, a rare breast cancer type, or previously took drugs that block PI3K, AKT, or mTOR for advanced breast cancer.
  • Cancer returned more than 12 months after finishing CDK4/6-based treatment given after initial treatment, with no treatment yet for cancer that spread.
  • Have ever had type 1 diabetes, or have type 2 diabetes that needs ongoing medicine. Cannot or will not swallow pills, or have trouble absorbing medicine through the gut.
  • Have ever had cancer in the tissue or fluid around the brain or spinal cord, or have untreated or active cancer spread to the brain or spinal cord. Some people with treated spread may qualify.
  • Have certain serious eye, lung, bowel, or liver conditions; need daily extra oxygen; or have ongoing death of jawbone tissue. Certain HIV-related conditions, other recent cancers, or long-term immune-suppressing drugs may also prevent joining.
  • Are pregnant, breastfeeding, or planning pregnancy during the study or the required time afterward. This is at least 60 days for the main study; for the sub-study, it is the longer of 2 weeks after inavolisib or 2 years after fulvestrant.
  • Have an active infection affecting the body, a recent serious infection, recent use of an experimental drug, or an allergy to the study drugs. The main study also excludes people with a history of severe skin reactions.
  • For the sub-study, use certain medicines or products that change how the body breaks down drugs, including St. John’s wort and grapefruit products, during the restricted period.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria for Main Study and Sub-study: * If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1 * Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent * Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed * 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 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Life expectancy of \> 6 months * Adequate hematologic and organ function prior to initiation of study treatment Exclusion Criteria for both Main Study and Sub-study: * Metaplastic breast cancer * Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway * Participant who relapsed with documented evidence of progression \> 12 months from completion of adjuvant CDK4/6i based therapy with no treatment for metastatic disease * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Inability or unwillingness to swallow pills * Malabsorption syndrome or other condition that would interfere with enteral absorption * Any history of leptomeningeal disease or carcinomatous meningitis * Known and untreated, or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases are eligible if they meet specific certain criteria * Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition * Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye * Requirement for daily supplemental oxygen * Symptomatic active lung disease, including pneumonitis * History of or active inflammatory bowel disease * Any active bowel inflammation * Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis * Participants with known human immunodeficiency virus infection that meet specific criteria * History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence * Chronic therapy of \>= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease * Active ongoing osteonecrosis of the jaw Exclusion Criteria for Main Study Only: * Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment * Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1 * Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer * Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulations * History of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic Symptoms Exclusion Criteria for Sub-study Only: * Pregnant, lactating, or breastfeeding, or intending to become pregnant during the substudy or within 2 weeks after the final dose of inavolisib and within 2 years after the final dose of fulvestrant, whichever is longer * Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day -4 of Cycle 1 * Investigational drug(s) within 4 weeks prior to Day -4 or within 5 half-lives of the investigational drug(s), whichever is longer * Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant formulations * Treatment with mild, moderate, or strong inducers of CYP2B6, CYP3A4, and/or CYP2C19 (including St. John's Wort) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1 * Treatment with mild, moderate, or strong inhibitors of CYP2B6, CYP3A4, and/or CYP2C19 (including grapefruit juice or supplements) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1

Study sites (39)

CA

CO

CT

FL

GA

KY

MA

MI

MN

NC

NJ

OH

OR

PA

TX

WA