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

June 5, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
        • Recruiting
        • Centro Oncologico Korben
      • Córdoba, Argentina, 5016
        • Recruiting
        • Hospital Privado - Centro Medico de Córdoba
      • Rosario, Argentina, S2002KDS
        • Recruiting
        • Hospital Provincial del Centenario
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000KPG
        • Recruiting
        • Instituto de Oncología de Rosario
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, NSW 2148
        • Recruiting
        • Blacktown Hospital
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Recruiting
        • Bendigo Cancer Centre
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires St-Luc
      • Hasselt, Belgium, 3500
        • Recruiting
        • Jessa Zkh (Campus Virga Jesse)
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven Gasthuisberg
  • Mexico
      • Mexico City, Mexico, 03100
        • Recruiting
        • CENEIT Oncologicos
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
      • Guadalajara, Jalisco, Mexico, 44680
        • Recruiting
        • RENATI INNOVATION S.A.P.I. de C.V
    • Querétaro
      • Queretaro Qro, Querétaro, Mexico, 76090
        • Recruiting
        • Centro de Infusion Tratamiento e Investigacion Oncologica S DE R
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron;Oncology
      • Granada, Spain, 18016
        • Recruiting
        • Hospital Universitario San Cecilio
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01120
        • Recruiting
        • Adana Baskent University Hospital
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • Memorial Ankara Hastanesi
      • Seyhan, Turkey (Türkiye)
        • Recruiting
        • Medical Park Seyhan Hospital
    • Istanbul
      • Bağcılar, Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Bagcilar Medipol Mega Universitesi Hastanesi
  • United Kingdom
      • Blackpool, United Kingdom, FY3 8NR
        • Recruiting
        • Blackpool Victoria Hospital
      • Harlow, United Kingdom, CM20 1QX
        • Recruiting
        • Princess Alexandra Hospital
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre
  • United States
    • California
      • Los Angeles, California, United States, 90017-4803
        • Recruiting
        • Los Angeles Cancer Network
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care East Brunswick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Inavolisib Dose A plus Fulvestrant
Participants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection.
Drug: Inavolisib
Participants will receive Inavolisib as per the schedule given in the protocol.
Drug: Fulvestrant
Participants will receive Fulvestrant as per the schedule given in the protocol.
Experimental: Inavolisib Dose B plus Fulvestrant
Participants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection.
Drug: Inavolisib
Participants will receive Inavolisib as per the schedule given in the protocol.
Drug: Fulvestrant
Participants will receive Fulvestrant as per the schedule given in the protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants With Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Progression-free Survival (PFS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Time to Response (TTR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Percentage of Participants With Treatment Discontinuation due to Adverse Events
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Number of Participants Reporting Presence, Frequency, Severity and/or Degree of Interference With Daily Activities of Symptomatic Treatment Toxicities as Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Percentage of Participants Reporting Presence and Frequency of Selected Hyperglycemia Symptoms as Assessed by European Organisation for Research and Treatment of Cancer (EORTC) IL382
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item General Population, Question 5 (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
Time Frame: Baseline, Up to approximately 2 years
Baseline, Up to approximately 2 years
Change from Baseline in Selected Hyperglycemia Symptoms as Assessed by EORTC IL382
Time Frame: Baseline, Up to approximately 2 years
Baseline, Up to approximately 2 years
Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item
Time Frame: Baseline, Up to approximately 2 years
Baseline, Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WO46063
  • 2025-522805-39-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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