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Breast CancerPhase 2NCT07405801

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

A Phase 2 study testing Inavolisib, Ribociclib and Fulvestrant in people with Breast Cancer, run by Hoffmann-La Roche at 58 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Inavolisib, Ribociclib and Fulvestrant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
58 sitesin 12 countries
Study dates
7 Apr 2026to 26 Feb 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

58 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: CO46274 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728

global-roche-genentech-trials@gene.com

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

58 sites in 12 countries

United States10 sites, 10 recruiting

  • Avera Cancer Institute - Aberdeen

    Aberdeen, South Dakota, 57401

    Recruiting

  • Los Angeles Cancer Network - Anaheim

    Anaheim, California, 92805

    Recruiting

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

    Recruiting

  • Avera Cancer Institute - Marshall

    Marshall, Minnesota, 56258

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Avera Cancer Institute - Mitchell

    Mitchell, South Dakota, 57301

    Recruiting

  • Stanford Cancer Institute

    Palo Alto, California, 94304

    Recruiting

  • Avera Cancer Institute - Pierre, SD

    Pierre, South Dakota, 57501

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Recruiting

  • AMG Oncology and Hematology Avera Cancer Institute - Yankton

    Yankton, South Dakota, 57078

    Recruiting

Other trials in United States

Italy6 sites, 6 recruiting

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

    Recruiting

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014

    Recruiting

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

    Recruiting

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

    Recruiting

  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

    Naples, Campania, 80131

    Recruiting

  • Università Campus Bio-Medico di Roma

    Rome, Lazio, 128

    Recruiting

Other trials in Italy

Spain6 sites, 6 recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016

    Recruiting

  • ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

    Recruiting

  • Hospital Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

France5 sites, 5 recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13273

    Recruiting

  • Institut Régional du Cancer de Montpellier

    Montpellier, 34298

    Recruiting

  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

    Toulouse, 31059

    Recruiting

Other trials in France

Germany5 sites, 5 recruiting

  • Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin

    Aachen, 52074

    Recruiting

  • Städtisches Klinikum Dessau

    Dessau, 06847

    Recruiting

  • Universitätsklinikum Essen

    Essen, 45122

    Recruiting

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120

    Recruiting

  • Universitätsklinik Tübingen

    Tübingen, 72076

    Recruiting

Other trials in Germany

Argentina4 sites, 4 recruiting

  • Inst. Alexander Fleming

    Buenos Aires, C1426ANZ

    Recruiting

  • Centro Oncologico Korben

    Caba, C1426AGE

    Recruiting

  • Centro Médico Fleischer

    Capital Federal, C1414

    Recruiting

  • Sanatorio de la Mujer

    Rosario, S2000ORE

    Recruiting

Other trials in Argentina

Brazil4 sites, 4 recruiting

  • Hospital Brasilia

    Brasília, Federal District, 71.635-610

    Recruiting

  • Ictrials Pesquisa e Desenvolvimento

    Curitiba, Paraná, 80510-130

    Recruiting

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317-000

    Recruiting

  • Hospital Santa Rita de Cassia Vitoria

    Vitória, Espírito Santo, 29043-260

    Recruiting

Other trials in Brazil

Canada4 sites, 4 recruiting

  • CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

    Chicoutimi, Quebec, G7H 5H6

    Recruiting

  • McGill University

    Montreal, Quebec, H4A 3J1

    Recruiting

  • Ottawa General Hospital

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5

    Recruiting

Other trials in Canada

Poland4 sites, 4 recruiting

  • Instytut "Centrum Zdrowia Matki Polki"

    ?ód?, 93-338

    Recruiting

  • Bialostockie Centrum Onkologii

    Bialystok, 15-027

    Recruiting

  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

    Lublin, 20-090

    Recruiting

  • Dolno?l?skie Centrum Onkologii

    Wroc?aw, 53-413

    Recruiting

Other trials in Poland

South Korea4 sites, 4 recruiting

  • Soon Chun Hyang University Cheonan Hospital

    Dongnam-gu, Cheonan-si, 31151

    Recruiting

  • Gachon University Gil Medical Center

    Namdong-Gu, 21565

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

Other trials in South Korea

Mexico3 sites, 3 recruiting

  • Instituto Nacional De Cancerologia

    Distrito Federal, Mexico CITY (federal District), 14000

    Recruiting

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020

    Recruiting

Other trials in Mexico

United Kingdom3 sites, 3 recruiting

  • Leicester Royal Infirmary

    Leicester, LE1 5WWi

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Recruiting

  • Christie Hospital Nhs Trust

    Manchester, M20 4GJ

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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).

Conditions
Breast Cancer
Being tested
Inavolisib, Ribociclib, Fulvestrant, Placebo
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InavolisibDrug

    Inavolisib will be administered as per the schedule mentioned in the protocol.

  • RibociclibDrug

    Ribociclib will be administered as per the schedule mentioned in the protocol.

  • FulvestrantDrug

    Fulvestrant will be administered as per the schedule mentioned in the protocol.

  • PlaceboDrug

    Placebo will be administered as per the schedule mentioned in the protocol.

Study groups in NCT07405801
Study groupRoleWhat they receive
Inavolisib + Ribociclib + FulvestrantExperimentalParticipants will receive inavolisib, ribociclib and fulvestrant.
Receives: Drug: Inavolisib; Drug: Ribociclib; Drug: Fulvestrant
Placebo + Ribociclib + FulvestrantPlacebo comparatorParticipants will receive placebo, ribociclib and fulvestrant.
Receives: Drug: Ribociclib; Drug: Fulvestrant; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Confirmed Objective Response (cORR)

    Measured: Up to approximately 2 years

Secondary outcomes (9)

  1. Progression-Free Survival (PFS)

    Measured: Up to approximately 2 years

  2. Overall Survival (OS)

    Measured: Up to approximately 2 years

  3. Duration of Response (DOR)

    Measured: Up to approximately 2 years

  4. Percentage of Participants with Clinical Benefit (CBR)

    Measured: Up to approximately 2 years

  5. Percentage of Participants with Adverse Events (AEs)

    Measured: Up to approximately 2 years

  6. 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)

    Measured: Up to approximately 2 years

  7. 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)

    Measured: Up to approximately 2 years

  8. Change From Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE

    Measured: Baseline, Up to approximately 2 years

  9. Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item

    Measured: Baseline, Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start7 Apr 2026
  3. Primary completion19 Dec 2028 (estimated)
  4. Study completion26 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07405801
Sponsor's protocol ID
CO46274
Other IDs
2025-523013-28-00, 2025
Status last verified
Oct 2026
First submitted
6 Feb 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inavolisib, Ribociclib and Fulvestrant in people with Breast Cancer, run by Hoffmann-La Roche at 58 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Italy, Spain, France, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: CO46274 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Confirmed Objective Response (cORR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07405801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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Clinical Trial NCT07405801 | AzTrials