Can a PI3K inhibitor boost presurgery breast cancer treatment?

NCT ID NCT05306041

Disease control Sponsor: GBG Forschungs GmbH Source: ClinicalTrials.gov ↗

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether adding the drug inavolisib to hormone therapy and the antibody combination trastuzumab plus pertuzumab helps shrink HER2-positive, HR-positive breast tumors before surgery. The trial enrolls 170 patients with early-stage breast cancer that has a PIK3CA mutation. Participants receive either the standard presurgery treatment or the same treatment plus inavolisib. The main goal is to see how many patients have no remaining invasive cancer in their breast and lymph nodes at surgery.

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 PI3K inhibitor, added to endocrine therapy and the antibody combination trastuzumab plus pertuzumab
What this could lead to: If it works, adding inavolisib could help more women clear their tumors before surgery, which may improve long-term outcomes.
What could go wrong: This is a phase 2 trial with 170 patients, so results may not hold in larger studies. Inavolisib can cause side effects like high blood sugar and rash, and the combination may not be better than standard treatment.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures. 2. Untreated, unilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration alone is not sufficient. Incisional biopsy is not allowed. 3. Tumor lesion in the breast must be measurable in two dimensions, preferably by sonography. 4. Patients must be in the following stages of disease: • cT1b - cT3 regardless of nodal status In patients with multifocal or multicentric breast cancer the largest lesion (target lesion) should be measured. 5. HR+/HER2+ disease with centrally confirmed ER-status, PR-status, HER2-status, PIK3CA mutation (tumor), Ki-67 value and TILs on core biopsy (target lesion). ER/PgR positive and HER2-positive is defined according to current ASCO/CAP guidelines. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy of target lesion has therefore to be sent to the GBG central pathology laboratory prior to randomization. In patients with multifocal or multicentric breast cancer, all non-target lesions must also be HR+/HER2+, as confirmed by local testing. 6. Age ≥ 18 years, female and male. 7. ECOG Performance status 0-1. 8. Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to randomization. Results for LVEF must be above 55%. 9. Laboratory requirements: Hematology * Absolute neutrophil count (ANC) ≥ 1.5/ nL * Platelets ≥ 100/ nL and * Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L) Hepatic function * Total bilirubin \< ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN * AST and ALT ≤ 1.5x ULN and * Alkaline phosphatase ≤ 2.5x ULN Glucose Metabolism: • Glycosylated hemoglobin (HbA1c) \< 6.5% 10. Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential. A woman is considered to be of childbearing potential if she is not hysterectomized or not postmenopausal. Postmenopausal is defined as: * ≥12 continuous months of amenorrhea with no identified cause other than menopause. * Having undergone bilateral oophorectomy. 11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for least 7 months after the last dose of PH-FDC SC. Examples of non-hormonal contraceptive methods with a failure rate of \< 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices. For men: men must remain abstinent or use a condom with a spermicidal product during the treatment period and for 7 months after the last dose of PH-FDC therapy to avoid exposing the embryo. Men and women must refrain from donating sperm/eggs during this same period. 12. Staging work-up according to country guidelines prior to randomization including: • Bilateral mammography and/or breast MRI in combination with a breast ultrasound. Exception: In men where MRI is medically not indicated breast ultrasound is sufficient. 13. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria 1. Patients with HER2-negative breast cancer and/or HER2-positive, HR-negative breast cancer. 2. Need of immediate neoadjuvant chemotherapy, e.g. inflammatory breast cancer. 3. Patients with definitive clinical or radiologic evidence of Stage IV cancer. 4. Excisional biopsy or lumpectomy and /or axillary lymph node dissection and/or sentinel lymph node biopsy performed prior to study entry (biopsy of clinical involved LN is warranted). 5. Prior chemotherapy or endocrine therapy or radiation therapy prior to study entry with the following exceptions: • If medically indicated, initiation of endocrine therapy up to 28 days prior to randomization and use of established fertility preservation methods in young patients interested in subsequent pregnancies is allowed. 6. Patients with a history of breast cancer are ineligible with the following exceptions: • Patient has been disease-free for more than 5 years and is at low risk for recurrence (at the investigator's discretion). 7. Patients with a history of any treated malignancy are ineligible in case of high risk of recurrence (at the investigator's discretion) and/or ongoing oncological treatment. This also applies to patients who are at high risk that oncological treatment is indicated during study therapy. 8. Patients with BMI\>30 can be included at the investigator's discretion. 9. Known hypersensitivity reaction to one of the compounds or substances, and/or murine proteins, and/or recombinant human hyaluronidase used in this protocol. 10. Patients with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on FPG and HbA1c. 11. Patients who are immunocompromised as the result of HIV or receiving immunosuppressive therapies. 12. Clinically significant and active liver disease, for example, sclerosing cholangitis, active viral hepatitis B or C infection, or autoimmune hepatic disorders. 13. Patients with inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, and active bowel inflammation (e.g., diverticulitis). 14. Patients with any concurrent ocular or intraocular condition, excluding baseline cataracts, that would require medical or surgical intervention during the study period to prevent or treat vision loss. In addition, patients with active uveitis or vitritis, history of uveitis, or active infectious process in the eye. 15. Patients with currently documented pneumonitis/interstitial lung disease. 16. Known or suspected congestive heart failure (\>NYHA I) and / or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP \>160 / 90 mm Hg under treatment with three antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease. 17. Damaged skin at planned site of subcutaneous (SC) injections (thigh). 18. Patients who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their INR. 19. Concurrent treatment with: • Chronic corticosteroids unless initiated \> 6 months prior to study entry and at low dose (10 mg or less methylprednisolone or equivalent). * Sex hormones. Prior treatment must be stopped before randomization (GnRH a is allowed). * Other experimental drugs or any other anti-cancer therapy. 20. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry. 21. Female patients: pregnancy or lactation at the time of randomization. 22. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent. 23. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.

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Conditions

The condition(s) this trial relates to.

HER2 positive breast carcinoma triple-positive breast carcinoma

As listed by the trial registrant

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

HER2-positive breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

61 sites in 6 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AOSS Antonio e Biagio e Cesare Arrigo
NOT_YET_RECRUITING

Alessandria, Italy
ASST Lecco Ospendale A. Manzoni
RECRUITING

Lecco, Italy
AULSS9 Scaligera - Ospedale Mater Salutis di Legnago
RECRUITING

Legnago, 37045, Italy
Center for Gynecologic Oncology
RECRUITING

Düsseldorf, 40235, Germany
Centrul ONCOMED SRI
RECRUITING

Timișoara, Romania
DBZ Onkologie
RECRUITING

Berlin, 12623, Germany
DIAKOVERE Henriettenstift Frauenklinik
RECRUITING

Hanover, 30171, Germany
Department of Breast-Center Holweide - Kliniken der Stadt Köln
RECRUITING

Cologne, 51067, Germany
Department of Gynecology and Obstetrics - University of Ulm
RECRUITING

Ulm, 89075, Germany
Elisabeth Krankenhaus Brustzentrum
RECRUITING

Kassel, 34117, Germany
Frauenklinik des Universitätsklinikums Erlangen
RECRUITING

Erlangen, 91054, Germany
Fundació IRB Lleida Oncología, Unidad de ensayos clínicos
RECRUITING

Lleida, Spain
Fundación Instituto Valenciano de Oncología (IVO)
RECRUITING

Valencia, Spain
GRN Klinik Weinheim
RECRUITING

Weinheim, 69469, Germany
Gemeinschaftspraxis Haematologie Onkologie
RECRUITING

Dresden, Germany
Helios Universitätsklinikum Wuppertal
RECRUITING

Wuppertal, 42283, Germany
Hospital Clinic of Barcelona Medical Oncology
RECRUITING

Barcelona, Spain
Hospital Clínico Universitario de Valencia
RECRUITING

Valencia, Spain
Hospital General Universitario Morales Meseguer
RECRUITING

Murcia, Spain
Hospital Universitari Vall d´Hebron
RECRUITING

Barcelona, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, Spain
Hospital Universitario Clinico San Cecilio Oncology
RECRUITING

Granada, Spain
Hospital Universitario Marquès de Valdecilla Servicio de Oncologia Medica
RECRUITING

Santander, Spain
Hospital Universitario Ramon y Cajal Servicio de Oncología Médica/ Oficina de Ensayos Clínicos
RECRUITING

Madrid, Spain
Hospital Universitario Son Espases
RECRUITING

Palma de Mallorca, Spain
Hospital Universitario Virgen der Rocio
RECRUITING

Seville, Spain
Hospital de Madrid Notre Sanchinarro (CIOCC)
RECRUITING

Madrid, Spain
Hämatologie-Onkologie im Zentrum MVZ GmbH
RECRUITING

Augsburg, 86150, Germany
Institut Catalá dÒncologia (ICO)
RECRUITING

Barcelona, Spain
Instituti Clinici Scientifici Maugeri S.p.A. SB Oncologia Medica
RECRUITING

Pavia, Italy
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
RECRUITING

Cluj-Napoca, Romania
Institutul Regional de Oncologie Iasi
RECRUITING

Iași, Romania
Istituto Europeo di Oncologica
RECRUITING

Milan, 20141, Italy
KEM Kliniken Essen-Mitte
RECRUITING

Essen, North Rhine-Westphalia, 45136, Germany
Klinik für Gynäkologie und Geburtshilfe Agaplesion Markus Krankenhaus
RECRUITING

Frankfurt, 60431, Germany
Klinik für Gynäkologie und Geburtshilfe, Brustzentrum/Studiensekretariat
RECRUITING

Berlin, Germany
Klinikum Chemnitz gGmbH
NOT_YET_RECRUITING

Chemnitz, Germany
Klinikum Hanau
RECRUITING

Hanau, 63450, Germany
Klinikum Worms
RECRUITING

Worms, 67550, Germany
Mammazentrum HH am Krankenhaus Jerusalem
RECRUITING

Hamburg, 20357, Germany
Media Vita GmbH (MVZ)
RECRUITING

Münster, 48145, Germany
Narodny onkologicky ustav
RECRUITING

Bratislava, Slovakia
Narodowy Instytut Onkologii
NOT_YET_RECRUITING

Warsaw, Poland
National Center for Tumor Diseases - University Hospital Heidelberg
RECRUITING

Heidelberg, 69120, Germany
Onkologische Schwerpunktpraxis Bielefeld
RECRUITING

Bielefeld, 33604, Germany
Ospedale di Circolo e Fondazione Macchi
NOT_YET_RECRUITING

Varese, Italy
Praxis für Hämatologie und Onkologie Koblenz and InVo - Institut für Versorgungsforschung in der Onkologie GbR
RECRUITING

Koblenz, 56068, Germany
Praxisklinik Krebsheilkunde für Frauen
RECRUITING

Berlin, 13597, Germany
SOC Oncologia S. Maria della Misericordia
RECRUITING

Udine, Italy
SRH Wald-Klinikum Gera GmbH
TERMINATED

Gera, 07548, Germany
Spitalul Clinic Filantropia
RECRUITING

Bucharest, Romania
St. Louise Frauen- und Kinderklinik
RECRUITING

Paderborn, Germany
Studienzentrale fuer das MVZ Eggenfelden e.K.
NOT_YET_RECRUITING

Eggenfelden, Germany
Städtisches Klinikum Dessau
RECRUITING

Dessau, 06847, Germany
University Hospital Carl Gustav Carus
RECRUITING

Dresden, 01307, Germany
University Hospital Gießen and Marburg, Campus Marburg
RECRUITING

Marburg, 35043, Germany
University Hospital Mannheim
RECRUITING

Mannheim, 68167, Germany
University Hospital Tübingen
RECRUITING

Tübingen, 72076, Germany
Università Politecnica delle Marche - Azienda Ospedaliero Universitarià delle Marche
NOT_YET_RECRUITING

Ancona, Italy
Universitätsklinikum Essen
NOT_YET_RECRUITING

Essen, Germany
Universitätsklinikum Schleswig-Holstein
NOT_YET_RECRUITING

Kiel, Germany
Uo Medicina Oncologica Ospedale Di Carpi
RECRUITING

Carpi, Italy

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