RightFit
RecruitingPhase 2

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

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic 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 plus fulvestrant works and how safe it is. It is for people with breast cancer that has grown nearby or spread, has a PIK3CA gene change, is hormone receptor-positive, and is HER2-negative. Their cancer must have worsened during or after treatment with a CDK4/6 inhibitor and hormone therapy.

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.

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

Eligibility

Who can join

  • Tests show the cancer uses estrogen to grow (ER-positive) and does not have high levels of HER2 (HER2-negative).
  • Cancer worsened during or after a CDK4/6 inhibitor plus hormone therapy, with no more than one prior course of drug treatment for advanced cancer.
  • The cancer can be measured or checked using the study’s rules.
  • Hormone-based treatment is recommended, and chemotherapy is not needed at study entry.
  • Tests show at least one PIK3CA gene change accepted by the study.
  • Expected to live more than 6 months.
  • Willing and able to follow study steps, including reporting symptoms and well-being.

Who can't join

  • A type of breast cancer called metaplastic breast cancer.
  • Past chemotherapy for cancer that came back and grew nearby or spread.
  • Type 2 diabetes that needs ongoing drug treatment at study entry, or any history of type 1 diabetes.
  • Past treatment with drugs that block PI3K, Akt, or mTOR for cancer that came back and grew nearby or spread.
  • Need for extra oxygen every day.
  • Current lung disease that causes symptoms, including pneumonitis (lung inflammation).

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

Official eligibility criteria

Inclusion Criteria: * Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting * 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 * Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation * Life expectancy of \> 6 months * Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes Exclusion Criteria: * Metaplastic breast cancer * Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting * Requirement for daily supplemental oxygen * Symptomatic active lung disease, including pneumonitis

Study sites (4)

CA

FL

MO

NJ