RightFit
RecruitingPhase 3

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

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 tests how well inavolisib works and how safe it is when added to a CDK4/6 inhibitor and letrozole as the first treatment for advanced breast cancer. It compares this with a placebo (no active drug) plus the same two medicines. It is for people whose cancer responds to hormone treatment, has a PIK3CA gene change, is hormone receptor-positive, and is HER2-negative.

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

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

Eligibility

Who can join

  • Women or men with breast cancer confirmed by a tissue or cell test.
  • Cancer must be hormone receptor-positive (uses hormones to grow) and HER2-negative (does not have high levels of the HER2 protein). If cancer is in both breasts, both must meet these rules.
  • Cancer was advanced when first found, or came back after at least 2 years of hormone treatment before or after surgery. For cancer that came back, it must not have worsened during that treatment and must have stayed away for at least 1 year after treatment ended.
  • Tests must confirm the required cancer marker, including the PIK3CA gene change.
  • Must agree to provide a new or stored tumor tissue sample.
  • Cancer must be measurable using the study's rules.
  • Must be fully active or able to do light work despite limits on hard physical activity.
  • Blood counts and organ function must meet study requirements within 14 days before treatment starts.

Who can't join

  • Pregnant, breastfeeding, or planning pregnancy during the study or while birth control is required.
  • Metaplastic breast cancer, a specific type of breast cancer; or past whole-body drug treatment for breast cancer that has spread or cannot be removed by surgery.
  • Any history of type 1 diabetes, or type 2 diabetes that needs ongoing medicine when joining.
  • Any history of cancer in the lining around the brain or spinal cord; or known untreated or active cancer spread to the brain or spinal cord. Previously treated spread may be allowed.
  • Current inflammation or infection in either eye; or past inflammation inside the eye with no known cause or caused by the immune system.
  • Active lung disease causing symptoms; any history of inflammatory bowel disease; or any current bowel inflammation.
  • Past blood stem cell or bone marrow transplant.
  • Recent use of medicines that strongly block or speed up CYP3A4, a protein that breaks down drugs. The listed waiting period is 4 weeks or 5 drug half-lives (a measure of how long a drug stays in the body).

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

Official eligibility criteria

Inclusion Criteria: * Women or men with histologically or cytologically confirmed carcinoma of the breast * Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Documented HER2-negative tumor according to ASCO/CAP guidelines * De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment * Participants who have bilateral breast cancers which are both HR-positive and HER2-negative * Confirmation of biomarker eligibility * Consent to provide fresh or archival tumor tissue specimen * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate hematologic and organ function within 14 days prior to initiation of study treatment Exclusion Criteria: * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required * Metaplastic breast cancer * Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Any history of leptomeningeal disease or carcinomatous meningitis * Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible * Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye * Symptomatic active lung disease * History of or active inflammatory bowel disease * Any active bowel inflammation * Prior hematopoietic stem cell or bone marrow transplantation * Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment

Study sites (62)

AZ

CA

FL

GA

IL

KY

MD

MI

MN

MO

NC

NE

NJ

NY

OH

OR

PA

SC

TN

TX

UT

WA