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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment120 people
  • Recruiting US sites6
  • SponsorHoffmann-La Roche
  • RegistryNCT07054190

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer: a one-minute explainerNCT070541901 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexFemale
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

inavolisib. An orally available inhibitor of phosphatidylinositol 3-kinase (PI3K), with potential antineoplastic activity. Upon administration, inavolisib binds to and inhibits various members of the PI3K family, including activating mutations in the catalytic alpha isoform PIK3CA. PI3K inhibition prevents the activation of the PI3K-mediated signaling pathway and results in the inhibition of growth and survival of PI3K-overexpressing tumor cells. Dysregulation of the PI3K signaling pathway is frequently associated with tumorigenesis and tumor resistance to a variety of antineoplastic agents and radiotherapy. PIK3CA, which encodes the p110-alpha catalytic subunit of the class I PI3K, is frequently mutated in a variety of cancer cell types and plays a key role in cancer cell growth and invasion. NCI Drug Dictionary

Treatments listed in the registry

  • Inavolisib (Drug): Inavolisib will be administered as per the schedule specified in the arms
  • Ribociclib (Drug): Ribociclib will be administered as per the schedule specified in the arms
  • Letrozole (Drug): Letrozole will be administered as per the schedule specified in the arms
  • Giredestrant (Drug): Giredestrant will be administered as per the schedule specified in the arms

The study

Treatment groups

Randomized · Parallel · masking: None

Arm A (Experimental)

Participants will receive inavolisib and letrozole orally (PO) once a day (QD) from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).

Arm B (Experimental)

Participants will receive a starting regimen of inavolisib and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).

Arm C (Experimental)

Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).

Arm D (non-randomized) (Experimental)

Participants will receive inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).

Arm E (Experimental)

Participants will receive inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days).

Arm F (Experimental)

Participants will receive a starting regimen of inavolisib and giredestrant PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + giredestrant as follows: inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days).

Arm G (Experimental)

Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and giredestrant PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + giredestrant as follows: inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days).

Goals

What the study measures

Main goals

  • Percentage of Participants with Adverse Events (AEs) (From first dose up to 30 days after last dose (approximately 8 months))

Other goals

  • Percentage of Participants with Total Pathological Complete Response (pCR)
  • Percentage of Participants with Objective Response Rate (ORR), According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST v1.1)
  • Change From Baseline in Ki-67 Levels by Immunohistochemistry (IHC)
  • Percentage of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
  • Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
  • Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
  • Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G GP5 Item

Planned enrollment: 120 (estimated).

Where

Recruiting US sites

  • Los Angeles Cancer Network, Los Angeles, California
  • Community Clinical Trials, Orange, California
  • West Cancer Center, Germantown, Tennessee
  • Texas Oncology - Central South, Austin, Texas
  • Texas Oncology - Northeast Texas, Flower Mound, Texas
  • West Virginia University, Morgantown, West Virginia

31 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 25, 2026. Public record; not medical advice.

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