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New targeted combo shows promise in slowing advanced breast cancer

NCT ID NCT04191499

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests whether adding the experimental drug inavolisib to two standard treatments (palbociclib and fulvestrant) can slow cancer growth in people with a specific genetic mutation (PIK3CA) in hormone receptor-positive, HER2-negative advanced breast cancer. About 325 participants whose cancer worsened after prior hormone therapy are enrolled. The main goal is to see how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inavolisib (a targeted drug) combined with palbociclib and fulvestrant
What this could lead to
If it works, this combination could offer a new treatment option that delays cancer growth for people with a specific genetic mutation in advanced breast cancer.
What could go wrong
This is a mid-to-late-stage trial, but results are not yet final. The drug may not improve outcomes enough to become standard care, and side effects from the combination could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

325 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Confirmed diagnosis of HR+/HER2- breast cancer * Metastatic or locally advanced disease not amenable to curative therapy * Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen * Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal * Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test) * Consent to provide fresh or archival tumor tissue specimen * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Life expectancy of \> 6 months * Adequate hematologic and organ function within 14 days prior to initiation of study treatment Exclusion Criteria * Metaplastic breast cancer * Any history of leptomeningeal disease or carcinomatous meningitis * Any prior systemic therapy for metastatic breast cancer * Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months * Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway * 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 CNS metastases. Patients with a history of treated CNS metastases may be eligible * Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period * Symptomatic active lung disease, or requiring daily supplemental oxygen * History of inflammatory bowel disease or active bowel inflammation * Anti-cancer therapy within 2 weeks before study entry * Investigational drug(s) within 4 weeks before randomization * Prior radiotherapy to \>= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation * Chronic corticosteroid therapy or immunosuppressants * Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 2 weeks after the final dose of study treatment * Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • A.O. Universitaria Di Parma

    Parma, Emilia-Romagna, 43100, Italy

  • Adana Baskent University Hospital

    Adana, 01120, Turkey (Türkiye)

  • Ambulantes Tumorzentrum Spandau

    Berlin, 13581, Germany

  • Anticancer Hospital Ag. Savas

    Athens, 115 22, Greece

  • Arthur J.E. Child Comprehensive Cancer Center-Calgary

    Calgary, Alberta, T2N 5G2, Canada

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Az. Osp. Spedali Civili

    Brescia, Lombardy, 25123, Italy

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • Blokhin Cancer Research Center

    Moscow, Moscow Oblast, 115552, Russia

  • Centre Georges Francois Leclerc

    Dijon, 21079, France

  • Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

    Clermont-Ferrand, 63003, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centro Clinico Champalimaud

    Lisbon, 1400-038, Portugal

  • Centro Oncologico Korben

    Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

  • Centro de Investigaciones Médicas y Desarrollo LC S.R.L

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE, Argentina

  • Chulabhorn Hospital

    Lak Si, 10210, Thailand

  • Churchill Hospital

    Oxford, OX3 7LJ, United Kingdom

  • City Clinical Hospital #4

    Dnipropetrovsk, 49102, Ukraine

  • Clinica Universidad de Navarra-Madrid

    Madrid, 28027, Spain

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinical Hospital Lapino (LLC Haven)

    Yudino, Moscow Oblast, 143081, Russia

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaén, 23007, Spain

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Ege University Medical Faculty

    Bornova, ?zm?r, 35100, Turkey (Türkiye)

  • Euromedical General Clinic of Thessaloniki

    Thessaloniki, 546 45, Greece

  • European Interbalkan Medical Center

    Thessaloniki, 570 01, Greece

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985, South Korea

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061, China

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, 201315, China

  • Fujian Medical University Union Hospital

    Fujian, 350001, China

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • Gulhane Training and Research Hospital

    Ankara, 06010, Turkey (Türkiye)

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Hebei Medical University Fourth Hospital

    Shijiazhuang, 050035, China

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hopital Prive Jean Mermoz

    Lyon, 69373, France

  • Hopital du Saint Sacrement

    Québec, Quebec, G1S 4L8, Canada

  • Hosp Provincial D. Centenarios

    Rosario, S2002KDS, Argentina

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Sultan Ismail

    Johor Bahru, Johor, 81100, Malaysia

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hubei Cancer Hospital

    Wuhan, 430079, China

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128, Italy

  • IPO do Porto

    Porto, 4200-072, Portugal

  • Insituto Catalán de Oncologia (ICO)

    Barcelona, 08907, Spain

  • Institut Universitaire du Cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • Instituto Valenciano Oncologia

    Valencia, 46009, Spain

  • Israel-Georgian Medical Research Clinic Healthycore

    Tbilisi, 0112, Georgia

  • Istanbul University Cerrahpasa Faculty of Medicine

    Istanbul, 34098, Turkey (Türkiye)

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5004, Hungary

  • Kaohsiung Medical Uni Chung-Ho Hospital

    Kaohsiung City, 807, Taiwan

  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH

    Essen, 45136, Germany

  • Klinikum Mutterhaus der Borromaeerinnen gGmbH

    Trier, 54290, Germany

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112, Taiwan

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115, Ukraine

  • Kyungpook National University Medical Center

    Daegu, 41404, South Korea

  • LLC Medscan

    Moskva, Moscow Oblast, 119421, Russia

  • London Regional Cancer Program, London Health Sciences Centre, Baines Centre

    London, Ontario, N6A 4L6, Canada

  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council

    Kryvyi Rih, 50048, Ukraine

  • MEDSI Clinical Hospital on Pyatnitsky Highway

    Moscow, Moscow Oblast, 143422, Russia

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109, Australia

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200, Thailand

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114, United States

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101, Australia

  • Medical Clinic "AB Medical group"

    Saint Petersburg, Sankt-Peterburg, 197082, Russia

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moscow Clinical Scientific Center

    Moscow, Moscow Oblast, 111123, Russia

  • Mount Vernon Hospital

    Northwood, HA6 2RN, United Kingdom

  • Municipal Institution SubCarpathian Clinical Oncological Centre

    Ivano-Frankivsk, KIEV Governorate, 76018, Ukraine

  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad

    Warsaw, 02-781, Poland

  • Narodowy Instytut Onkologii Odzia? w Gliwicach

    Gliwice, 44-102, Poland

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • National Cancer Centre

    Singapore, 168583, Singapore

  • National Cancer Institute IKN

    Putrajaya, Federal Territory of Putrajaya, 62250, Malaysia

  • National Taiwan Uni Hospital

    Taipei, 100, Taiwan

  • National University Hospital

    Singapore, 119228, Singapore

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120, Germany

  • Northwest Medical Specialties

    Tacoma, Washington, 98405, United States

  • Orszagos Onkologiai Intezet

    Budapest, 1122, Hungary

  • Ospedale Santa Maria Annunziata

    Bagno a Ripoli, Tuscany, 50012, Italy

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • Palmerston North Hospital

    Palmerston North, 4442, New Zealand

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5, Canada

  • Prof. Dr. Cemil Tascioglu City Hospital

    Istanbul, 34384, Turkey (Türkiye)

  • Przychodnia Lekarska KOMED, Roman Karaszewski

    Konin, 625000, Poland

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040, Russia

  • Royal Marsden Hospital - Fulham

    London, SW3 6JJ, United Kingdom

  • SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU

    Kharkiv, Kharkiv Governorate, 61018, Ukraine

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

  • Sarah Cannon Research Institute / Tennessee Oncology

    Chattanooga, Tennessee, 37403, United States

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Sarawak General Hospital

    Sarawak, Sarawak, 93586, Malaysia

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500, Australia

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060, China

  • Tbilisi Oncology Dispensary

    Tbilisi, 0159, Georgia

  • Texas Oncology - Central South

    Austin, Texas, 78731, United States

  • Texas Oncology - Northeast Texas

    Tyler, Texas, 75702, United States

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905, United States

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • Tri-Service General Hospital, Division of General Surgery

    Taipei, 114, Taiwan

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Univ General Hosp Heraklion

    Heraklion, 711 10, Greece

  • Universitätsfrauenklinik Ulm

    Ulm, 89075, Germany

  • Universitätsklinikum Mannheim

    Mannheim, 68167, Germany

  • Uzhhorod Central City Clinical Hospital

    Uzhhorod, KIEV Governorate, 88000, Ukraine

  • Uzsoki Utcai Korhaz

    Budapest, 1145, Hungary

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

  • Vejle Sygehus

    Vejle, 7100, Denmark

  • Veterans General Hospital

    Taipei, 00112, Taiwan

  • Volgograd Regional Clinical Oncology Dispensary

    Volgograd, 400138, Russia

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Western Health

    Fitzroy, Victoria, 3065, Australia

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

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