RightFit
RecruitingPhase 2

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated 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
Female only
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 safe inavolisib is and how well it works when used with other treatments. It is for people with untreated Stage II–III breast cancer that has a PIK3CA gene change, uses estrogen to grow (ER-positive), and is HER2-negative, meaning it does not have high levels of the HER2 protein.

This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

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

Eligibility

Who can join

  • Have Stage II–III invasive breast cancer confirmed by a tissue test. The cancer may or may not be removable by surgery.
  • Be able to receive treatment before surgery and be a good fit for a combination of treatments that includes hormone therapy.
  • Be willing to have breast surgery after treatment, unless the cancer cannot be removed by surgery.
  • Have a tumor that is ER-positive, meaning it uses estrogen to grow.
  • Have a tumor that is HER2-negative, meaning it does not have high levels of the HER2 protein.
  • Have a Ki-67 score of at least 5%. This test measures how many cancer cells are growing and dividing.
  • Have a confirmed change in the PIK3CA gene.

Who can't join

  • Have Stage IV breast cancer, which has spread to distant parts of the body.
  • Have inflammatory breast cancer, a type that affects the skin of the breast.
  • Have invasive cancer in both breasts.
  • Have had ductal or lobular carcinoma in situ (abnormal cells within breast ducts or milk-making glands) and received whole-body treatment for it or radiation to the same breast.
  • Have already had treatment for the current breast cancer. This includes surgery or a biopsy that removes the tumor, underarm lymph node surgery or biopsy, radiation, chemotherapy, or hormone treatment.
  • Have Type 2 diabetes that needs ongoing medicine when joining the study, or have any history of Type 1 diabetes.

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

Official eligibility criteria

Inclusion Criteria: * Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification * Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy * Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable) * Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines * Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines * Documented Ki-67 score \>=5% as per local assessment * Confirmed PIK3CA mutation Exclusion Criteria: * Stage IV (metastatic) BC * Inflammatory BC (cT4d) * Bilateral invasive BC * History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast * Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, and sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments) * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

Study sites (4)

CA

TN

WV