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RecruitingPhase 2

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation

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 ribociclib and fulvestrant, compared with a placebo (no active drug) added to those medicines. It is for people with advanced breast cancer that uses hormones to grow, is HER2-negative, and has grown despite hormone-blocking treatment.

A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-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. The cancer has spread nearby or to other parts of the body and cannot be cured with surgery or radiation.
  • The latest tumor sample shows that at least 1% of cancer cells have receptors for estrogen or progesterone, hormones that can help cancer grow.
  • No past treatment that travels through the body for advanced breast cancer that cannot be removed by surgery or has spread to distant parts of the body.
  • Cancer grew during hormone-blocking treatment given after initial treatment, or within 12 months after finishing it. That treatment must have included an aromatase inhibitor or tamoxifen.
  • A central lab must test a tumor sample and find no PIK3CA gene change and a missing copy of part of chromosome 8, called 8p.
  • The cancer must be measurable using the study's standard rules.

Who can't join

  • Metaplastic breast cancer, a specific type of breast cancer.
  • Radiation treatment within 2 weeks before being assigned to a study group.
  • Chemotherapy is the right treatment at study entry under local or national guidelines, such as when cancer seriously affects organ function.
  • Type 2 diabetes that needs ongoing medicine at study entry, or any history of type 1 diabetes.
  • Cancer spread to the brain or spinal cord that is untreated or active, including cancer that is growing or needs seizure medicines or steroids to control symptoms. Previously treated spread may be allowed.
  • Any history of cancer in the tissue or fluid surrounding the brain and spinal cord.

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 that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent * Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as \>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020) * Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen * Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss) * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Exclusion Criteria: * Metaplastic breast cancer * Radiotherapy within 2 weeks before randomization * Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis) * 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 Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible * Any history of leptomeningeal disease or carcinomatous meningitis

Study sites (10)

CA

FL

MN

SD

WI