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

September 4, 2026 updated by: Hoffmann-La Roche

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

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).

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.
  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Inst. Alexander Fleming
      • Caba, Argentina, C1426AGE
        • Recruiting
        • Centro Oncológico Korben
      • Capital Federal, Argentina, C1414
        • Recruiting
        • Centro Medico Fleischer
      • Rosario, Argentina, S2000ORE
        • Recruiting
        • Sanatorio de La Mujer
  • Brazil
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29043-260
        • Recruiting
        • Hospital Santa Rita de Cassia Vitoria
    • Federal District
      • Brasília, Federal District, Brazil, 71.635-610
        • Recruiting
        • Hospital Brasilia
    • Paraná
      • Curitiba, Paraná, Brazil, 80510-130
        • Recruiting
        • Ictrials Pesquisa e Desenvolvimento
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01317-000
        • Recruiting
        • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Science Centre
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Recruiting
        • CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University
  • France
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Recruiting
        • Centre Léon Bérard
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli Calmettes
      • Montpellier, France, 34298
        • Recruiting
        • Institut régional du Cancer de Montpellier
      • Toulouse, France, 31059
        • Recruiting
        • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin
      • Dessau, Germany, 06847
        • Recruiting
        • Städtisches Klinikum Dessau
      • Essen, Germany, 45122
        • Recruiting
        • Universitätsklinikum Essen
      • Heidelberg, Germany, 69120
        • Recruiting
        • Nationales Centrum für Tumorerkrankungen (NCT)
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinik Tübingen
  • Italy
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
    • Lazio
      • Rome, Lazio, Italy, 128
        • Recruiting
        • Università Campus Bio-Medico di Roma
    • Lombardy
      • Bergamo, Lombardy, Italy, 24127
        • Recruiting
        • Asst Papa Giovanni Xxiii
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Irccs Istituto Nazionale Dei Tumori (Int)
  • Mexico
      • Guadalajara, Mexico, 44280
        • Recruiting
        • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
    • Mexico CITY (federal District)
      • Distrito Federal, Mexico CITY (federal District), Mexico, 14000
        • Recruiting
        • Instituto Nacional de Cancerologia
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca
  • Poland
      • ?ód?, Poland, 93-338
        • Recruiting
        • Instytut "Centrum Zdrowia Matki Polki"
      • Bialystok, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii
      • Lublin, Poland, 20-090
        • Recruiting
        • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
      • Wroc?aw, Poland, 53-413
        • Recruiting
        • Dolno?l?skie Centrum Onkologii
  • South Korea
      • Dongnam-gu, Cheonan-si, South Korea, 31151
        • Recruiting
        • Soon Chun Hyang University Cheonan Hospital
      • Namdong-Gu, South Korea, 21565
        • Recruiting
        • Gachon University Gil Medical Center
      • Seongnam-si, South Korea, 13605
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic Barcelona
      • Granada, Spain, 18016
        • Recruiting
        • Hospital Universitario Clínico San Cecilio
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Ramon y Cajal
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • ICO l'Hospitalet
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WWi
        • Recruiting
        • Leicester Royal Infirmary
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
      • Manchester, United Kingdom, M20 4GJ
        • Recruiting
        • Christie Hospital Nhs Trust
  • United States
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Los Angeles Cancer Network - Anaheim
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Cancer Specialists of North Florida
    • Minnesota
      • Marshall, Minnesota, United States, 56258
        • Recruiting
        • Avera Cancer Institute - Marshall
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Recruiting
        • Avera Cancer Institute - Aberdeen
      • Mitchell, South Dakota, United States, 57301
        • Recruiting
        • Avera Cancer Institute - Mitchell
      • Pierre, South Dakota, United States, 57501
        • Recruiting
        • Avera Cancer Institute - Pierre, SD
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
      • Yankton, South Dakota, United States, 57078
        • Recruiting
        • AMG Oncology and Hematology Avera Cancer Institute - Yankton
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin

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:

  • 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 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: Quadruple

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 + Ribociclib + Fulvestrant
Participants will receive inavolisib, ribociclib and fulvestrant.
Drug: Inavolisib
Inavolisib will be administered as per the schedule mentioned in the protocol.
Drug: Ribociclib
Ribociclib will be administered as per the schedule mentioned in the protocol.
Drug: Fulvestrant
Fulvestrant will be administered as per the schedule mentioned in the protocol.
Placebo Comparator: Placebo + Ribociclib + Fulvestrant
Participants will receive placebo, ribociclib and fulvestrant.
Drug: Ribociclib
Ribociclib will be administered as per the schedule mentioned in the protocol.
Drug: Fulvestrant
Fulvestrant will be administered as per the schedule mentioned in the protocol.
Drug: Placebo
Placebo will be administered as per the schedule mentioned 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 Confirmed Objective Response (cORR)
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
Overall Survival (OS)
Time Frame: Up to approximately 2 years
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
Percentage of Participants with Clinical Benefit (CBR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Percentage of Participants with Adverse Events (AEs)
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 Function of Symptomatic Treatment Toxicities 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
Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) From the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Change From Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE
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.
April 7, 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.
December 19, 2028

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.
February 26, 2030

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).
February 6, 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.
February 6, 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.
February 12, 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.
September 8, 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.
September 4, 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.
September 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.
  • CO46274
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523013-28-00 (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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