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HER2-positive Breast CancerPhase 2GeparPiPPaNCT05306041

Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

A Phase 2 study testing Inavolisib, PHESGO and Endocrine therapy in people with HER2-positive Breast Cancer, run by GBG Forschungs GmbH at 62 sites in 6 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
Inavolisib, PHESGO and Endocrine therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
62 sitesin 6 countries
Study dates
2 Jan 2023to Mar 2027
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

  • Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
  • Untreated, unilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration alone is not sufficient. Incisional biopsy is not allowed.
  • Tumor lesion in the breast must be measurable in two dimensions, preferably by sonography.
  • 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.
  • 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.
Show all 27Show fewer
  • Age ≥ 18 years, female and male.
  • ECOG Performance status 0-1.
  • 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%.
  • 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%
  • 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.
  • 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.
  • 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.
  • Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • Patients with HER2-negative breast cancer and/or HER2-positive, HR-negative breast cancer.
  • Need of immediate neoadjuvant chemotherapy, e.g. inflammatory breast cancer.
  • Patients with definitive clinical or radiologic evidence of Stage IV cancer.
  • 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).
  • 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.
Show all 27Show fewer
  • 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).
  • 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.
  • Patients with BMI>30 can be included at the investigator's discretion.
  • Known hypersensitivity reaction to one of the compounds or substances, and/or murine proteins, and/or recombinant human hyaluronidase used in this protocol.
  • Patients with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on FPG and HbA1c.
  • Patients who are immunocompromised as the result of HIV or receiving immunosuppressive therapies.
  • Clinically significant and active liver disease, for example, sclerosing cholangitis, active viral hepatitis B or C infection, or autoimmune hepatic disorders.
  • Patients with inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, and active bowel inflammation (e.g., diverticulitis).
  • 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.
  • Patients with currently documented pneumonitis/interstitial lung disease.
  • 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.
  • Damaged skin at planned site of subcutaneous (SC) injections (thigh).
  • 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.
  • 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.
  • Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
  • Female patients: pregnancy or lactation at the time of randomization.
  • History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.

Trial locations and contacts

62 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Jana Roßney contact

+49(0)6102 7480 ext. 292

geparpippa@gbg.de

62 sites in 6 countries

Germany33 sites, 32 recruiting

  • Hämatologie-Onkologie im Zentrum MVZ GmbH

    Augsburg, 86150

    Dr. med. Bernhard Heinrich

    Recruiting

  • DBZ Onkologie

    Berlin, 12623

    Dr. med. Antje Müller

    Recruiting

  • Praxisklinik Krebsheilkunde für Frauen

    Berlin, 13597

    Gülten Oskay-Özcelik

    Recruiting

  • Klinik für Gynäkologie und Geburtshilfe, Brustzentrum/Studiensekretariat

    Berlin

    Michael Untch, Prof. Dr. med.

    Recruiting

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, 33604

    Dr. med. Siemke Steinke

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz

    Paul Gaß, Prof. Dr. med.

    Not yet recruiting

  • Department of Breast-Center Holweide - Kliniken der Stadt Köln

    Cologne, 51067

    Myriam Vincent

    Recruiting

  • Städtisches Klinikum Dessau

    Dessau, 06847

    Dr. med. Hermann Voß

    Recruiting

  • University Hospital Carl Gustav Carus

    Dresden, 01307

    Dr. med. Theresa Link

    Recruiting

  • Gemeinschaftspraxis Haematologie Onkologie

    Dresden

    Thomas Ilmer, PD Dr. med.

    Recruiting

  • Center for Gynecologic Oncology

    Düsseldorf, 40235

    Dr. med. Athina Kostara

    Recruiting

  • Studienzentrale fuer das MVZ Eggenfelden e.K.

    Eggenfelden

    Jürgen Terhaag, Dr. med.

    Not yet recruiting

  • Frauenklinik des Universitätsklinikums Erlangen

    Erlangen, 91054

    Prof. Dr. med. MD Peter Fasching

    Recruiting

  • KEM Kliniken Essen-Mitte

    Essen, North Rhine-Westphalia, 45136

    Johanna Frindte

    Recruiting

  • Universitätsklinikum Essen

    Essen

    Ann-Kathrin Bittner, Prof. Dr. med.

    Not yet recruiting

  • Klinik für Gynäkologie und Geburtshilfe Agaplesion Markus Krankenhaus

    Frankfurt, 60431

    Prof. Dr. med. Marc Thill

    Recruiting

  • SRH Wald-Klinikum Gera GmbH

    Gera, 07548

    Terminated

  • Mammazentrum HH am Krankenhaus Jerusalem

    Hamburg, 20357

    Prof. Dr. med. Christian Schem

    Recruiting

  • Klinikum Hanau

    Hanau, 63450

    Dr. med. Jens Kosse

    Recruiting

  • DIAKOVERE Henriettenstift Frauenklinik

    Hanover, 30171

    Dr. med. Kristina Lübbe

    Recruiting

  • National Center for Tumor Diseases - University Hospital Heidelberg

    Heidelberg, 69120

    Prof. Dr. med. Andreas Schneeweiss

    Recruiting

  • Elisabeth Krankenhaus Brustzentrum

    Kassel, 34117

    Dr. med. Sabine Schmatloch

    Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Kiel

    Marion van Mackelenbergh, Prof. Dr. med.

    Not yet recruiting

  • Praxis für Hämatologie und Onkologie Koblenz and InVo - Institut für Versorgungsforschung in der Onkologie GbR

    Koblenz, 56068

    Prof. Dr. med. Rudolf Weide

    Recruiting

  • University Hospital Mannheim

    Mannheim, 68167

    Priv. Doz. Dr. med. Mattea Reinisch

    Recruiting

  • University Hospital Gießen and Marburg, Campus Marburg

    Marburg, 35043

    Dr. med. Niklas Gremke

    Recruiting

  • Media Vita GmbH (MVZ)

    Münster, 48145

    Dr. med. Stefanie Wiebe

    Recruiting

  • St. Louise Frauen- und Kinderklinik

    Paderborn

    Michael Patrick Lux, Prof. Dr. med.

    Recruiting

  • University Hospital Tübingen

    Tübingen, 72076

    Prof. Dr. med. Andreas Hartkopf

    Recruiting

  • Department of Gynecology and Obstetrics - University of Ulm

    Ulm, 89075

    PhD MD Brigitte Rack

    Recruiting

  • GRN Klinik Weinheim

    Weinheim, 69469

    Dr. med. Lelia-Eveline Bauer

    Recruiting

  • Klinikum Worms

    Worms, 67550

    Dr. med. Sebastian Züfle

    Recruiting

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283

    Assoz. Prof. Priv.Doz. Dr. med. univ et scient. med., MBAVesna Bjelic-Radisic

    Recruiting

Other trials in Germany

Spain14 sites, 14 recruiting

  • Hospital Clinic of Barcelona Medical Oncology

    Barcelona

    Francesco Schettini, MD, PhD

    Recruiting

  • Hospital Universitari Vall d´Hebron

    Barcelona

    Santiago Escrivá de Romani Munoz, Dr. med.

    Recruiting

  • Institut Catalá dÒncologia (ICO)

    Barcelona

    Sonia Pernas Simon, Dr. med.

    Recruiting

  • Hospital Universitario Clinico San Cecilio Oncology

    Granada

    Isabel Blancas, Dr. med.

    Recruiting

  • Fundació IRB Lleida Oncología, Unidad de ensayos clínicos

    Lleida

    Serafin Morales, Dr. med.

    Recruiting

  • Hospital de Madrid Notre Sanchinarro (CIOCC)

    Madrid

    Ana Luna Barrera

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Rodrigo Sanchez Bayona, Dr. med.

    Recruiting

  • Hospital Universitario Ramon y Cajal Servicio de Oncología Médica/ Oficina de Ensayos Clínicos

    Madrid

    Elena Lopez Miranda

    Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia

    Elisa Garcia Garre, MD PhD

    Recruiting

  • Hospital Universitario Son Espases

    Palma de Mallorca

    Nieves Ferrer Tur, Dr, med.

    Recruiting

  • Hospital Universitario Marquès de Valdecilla Servicio de Oncologia Medica

    Santander

    Carmen Hinojo Gonzalez, Dr. med.

    Recruiting

  • Hospital Universitario Virgen der Rocio

    Seville

    Javier Salvador, Dr. med.

    Recruiting

  • Fundación Instituto Valenciano de Oncología (IVO)

    Valencia

    Cristina Hernando Meliá, Dr. med.

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia

    Juan Miguel Cejalvo, Dr. med.

    Recruiting

Other trials in Spain

Italy9 sites, 9 recruiting

  • AOSS Antonio e Biagio e Cesare Arrigo

    Alessandria

    Maura Vincenti, Dr. med.

    Not yet recruiting

  • Università Politecnica delle Marche - Azienda Ospedaliero Universitarià delle Marche

    Ancona

    Prof. Rossana Berardi

    Not yet recruiting

  • Uo Medicina Oncologica Ospedale Di Carpi

    Carpi

    Katia Cagossi, Dr. med., k.cagossi@ausl.mo.it

    Recruiting

  • ASST Lecco Ospendale A. Manzoni

    Lecco

    Antonio Ardizzola, Dr. med.

    Recruiting

  • AULSS9 Scaligera - Ospedale Mater Salutis di Legnago

    Legnago, 37045

    Dr. med. Anna Mercanti

    Recruiting

  • Istituto Europeo di Oncologica

    Milan, 20141

    MD Marco Colleoni

    Recruiting

  • Instituti Clinici Scientifici Maugeri S.p.A. SB Oncologia Medica

    Pavia

    Laura Locati, MD, PhD

    Recruiting

  • SOC Oncologia S. Maria della Misericordia

    Udine

    Elena Poletto

    Recruiting

  • Ospedale di Circolo e Fondazione Macchi

    Varese

    Elisa Gallerani, Dr. med.

    Not yet recruiting

Other trials in Italy

Romania4 sites, 4 recruiting

  • Spitalul Clinic Filantropia

    Bucharest

    Dragos Median, Dr. med.

    Recruiting

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca

    Nicoleta Antone, Dr. med.

    Recruiting

  • Institutul Regional de Oncologie Iasi

    Iași

    Simona Volovat, Dr. med.

    Recruiting

  • Centrul ONCOMED SRI

    Timișoara

    Cristina Oprean, Dr. med.

    Recruiting

Other trials in Romania

Poland1 site, 1 recruiting

  • Narodowy Instytut Onkologii

    Warsaw

    Zbigniew Nowecki, Prof. Dr. med.

    Not yet recruiting

Other trials in Poland

Slovakia1 site, 1 recruiting

  • Narodny onkologicky ustav

    Bratislava

    Michal Mego

    Recruiting

Other trials in Slovakia

About this study

Official title: A Randomized, Open-label, Phase II Trial Comparing Neoadjuvant Endocrine Therapy in Combination With Trastuzumab, Pertuzumab +/- the PI3K Inhibitor Inavolisib in Patients With HER2-positive, HR-positive, PIK3CA Mutant Early Breast Cancer-GeparPiPPa

Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.

Read the detailed description

This is a multicenter, prospective, randomized, open-label, parallel-group, phase II study to evaluate the potential incremental efficacy and safety of inavolisib in the neoadjuvant treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.

170 patients with confirmed eligibility criteria and PIK3CA mutant breast cancer will be randomized in a 1:1 ratio to receive: Neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous (PH-FDC SC) formulation q3w for 6 cycles (18 weeks) with (6cycles) or without inavolisib. Endocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue for premenopausal women and men.

In both study arms, treatment will be given until surgery/core-biopsy, disease progression, unacceptable toxicity, or withdrawal of consent of the patient.

All patients will undergo surgery or biopsy after completing study therapy to assess pCR rate.

Being tested
Inavolisib, PHESGO, Endocrine therapy
Keywords
GeparPiPPa, German Breast Group

What participants receive

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

  • InavolisibDrug

    daily application of 9 mg (may be decreased to 6 mg and to 3 mg)

  • PHESGODrug

    fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase s.c. (PH-FDC SC) q3w beginning on day 1 of cycle 1 for 6 cycles (18 weeks)

  • Endocrine therapyDrug

    Endocrine therapy per physician´s choice with either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue for premenopausal women and men

Study groups in NCT05306041
Study groupRoleWhat they receive
InavolisibExperimentalInavolisib for 6 cycles (18 weeks) Neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous (PH-FDC SC) formulation q3w for 6 cycles (18 weeks)
Receives: Drug: Inavolisib; Drug: PHESGO; Drug: Endocrine therapy
without InavolisibOtherNeoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous (PH-FDC SC) formulation q3w for 6 cycles (18 weeks)
Receives: Drug: PHESGO; Drug: Endocrine therapy

What is being measured

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

  1. Pathologic complete response in the breast and axillary lymph nodes (ypT0/is ypN0)

    Pathological complete response (ypT0/is ypN0) is defined as no microscopic evidence of residual invasive tumor cells in all resected specimens of the breast and axilla.

    Measured: 21 weeks (time window + 3 weeks)

Secondary outcomes (8)

  1. Rates of ypT0 ypN0; ypT0 ypN0/+; ypT0/is ypN0/+; ypT(any) ypN0

    ypT0 ypN0 is defined as no microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast and axilla; ypT0 ypN0/+ is defined as no microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast; ypT0/Tis ypN0/+ is defined as no microscopic evidence of residual invasive viable tumor cells in all resected specimens of the breast

    Measured: 21 weeks (time window + 3 weeks)

  2. pCR rates per arm separately for the stratified subpopulations

    Pathological complete response (ypT0/is ypN0) is defined as no microscopic evidence of residual invasive tumor cells in all resected specimens of the breast and axilla.

    Measured: 21 weeks (time window + 3 weeks)

  3. Response rates of the breast tumor and axillary nodes based on physical examination and imaging tests (sonography, mammography, or MRI) after study treatment in both arms

    Clinical (c) and imaging (i) response will be assessed every 2nd cycle and before surgery by physical examination and imaging tests. Sonography is the preferred examination.

    The response categories of the breast are:

    • Complete response (CR): complete disappearance of all tumor signs in the breast
    • Partial response (PR): reduction in the product of the two largest perpendicular diameters of the primary tumor size by 50% or more
    • Stable disease (NC): no significant change in tumor size during treatment which means an estimated reduction of the tumor area by less than 50%, or an estimated increase in the size of the tumor area lesions of less than 25%
    • Progressive disease (PD): development of new, previously undetected lesions, or an estimated increase in the size of pre-existing lesions by 25% or more after at least two cycles of therapy

    Measured: 21 weeks (time window + 3 weeks)

  4. Percentage of patients receiving additional neoadjuvant chemotherapy after residual disease was confirmed by core biopsy at the end of study treatment

    In case of ycT0 and no tumor residuals in the biopsy, it is recommended to undergo surgery. Further neoadjuvant or adjuvant treatment including chemotherapy, radiotherapy, endocrine therapy and HER2-therapy will be administered at the discretion of the investigator and according to standard of care.

    Measured: 21 weeks (time window + 3 weeks)

  5. Breast conservation rate after treatment

    Breast conservation is defined as tumorectomy, segmentectomy or quadrantectomy as a most radical surgery.

    Measured: 21 weeks (time window + 3 weeks)

  6. Safety and tolerability profile (haematological and non-haematological adverse events) after the first 20 and the first 40 patients who started therapy and have completed two cycles of therapy

    Tolerability and safety analyses include assessment of patients whose treatment had to be dose reduced, delayed or permanently stopped. The reason for treatment discontinuation includes aspects of efficacy (e.g. discontinuation due to tumor progression), safety (e.g. discontinuation due to haematological and non-haematological adverse events) and compliance (e.g. discontinuation due to withdrawal of consent). Safety by toxicity grades are defined by the NCI-CTCAE version 5.0

    Measured: 6 weeks

  7. Overall safety and tolerability and treatment compliance in the two arms

    Descriptive statistics for the 2 treatment arms will be given on the number of patients whose treatment had to be dose reduced, delayed or permanently stopped. Reasons for premature discontinuation will be categorized according to the main reason and will be presented in frequency tables. Safety by toxicity grades are defined by the NCI-CTCAE version 5.0, laboratory parameters will be converted in CTC-grades and reported together with other adverse events.

    Measured: 21 weeks (time window + 3 weeks)

  8. Invasive disease-free survival (IDFS) and overall survival (OS) in both arms and according to stratified subpopulations (data collected within a registry).

    Survival endpoints are defined as the time period between randomization and first event and will be analyzed after the end of the study by referring to data from GBG´s registries

    Measured: up to 5 years

Timeline

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

  1. First posted31 Mar 2022
  2. Study start2 Jan 2023
  3. Primary completionJan 2027 (estimated)
  4. Study completionMar 2027 (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
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05306041
Sponsor's protocol ID
GBG105
Acronym
GeparPiPPa
Status last verified
Sep 2026
First submitted
9 Mar 2022
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inavolisib, PHESGO and Endocrine therapy in people with HER2-positive Breast Cancer, run by GBG Forschungs GmbH at 62 sites in 6 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 27 inclusion and 27 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Germany, Spain, Italy, Romania, Poland and 1 more country. 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. 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 Jana Roßney (+49(0)6102 7480 ext. 292, geparpippa@gbg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response in the breast and axillary lymph nodes (ypT0/is ypN0) (time frame: 21 weeks (time window + 3 weeks)). 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 NCT05306041.

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 11 Sep 2026.

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