Actively Recruiting
Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer
Led by GBG Forschungs GmbH · Updated on 2025-02-17
170
Participants Needed
29
Research Sites
208 weeks
Total Duration
On this page
Sponsors
G
GBG Forschungs GmbH
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before starting study procedures
- Have untreated, unilateral primary breast cancer confirmed by core biopsy
- Tumor measurable in two dimensions, preferably by sonography
- Disease stage cT1b to cT3, any nodal status
- HR-positive, HER2-positive breast cancer with confirmed ER, PR, HER2 status, PIK3CA mutation, Ki-67, and TILs
- Age 18 years or older, any gender
- ECOG performance status 0 or 1
- Normal cardiac function with LVEF > 55% confirmed within 3 months before randomization
- Hematology: ANC ≥ 1.5/nL, platelets ≥ 100/nL, hemoglobin ≥ 10 g/dL
- Liver function: bilirubin below upper limit of normal (ULN) except Gilbert's syndrome allowances; AST and ALT ≤ 1.5x ULN; alkaline phosphatase ≤ 2.5x ULN
- Glycosylated hemoglobin (HbA1c) < 6.5%
- Negative pregnancy test within 14 days before randomization for women of childbearing potential
- Women of childbearing potential agree to use effective contraception or abstain during treatment and 7 months after last dose
- Men agree to use contraception or abstain during treatment and 7 months after last dose
- Completed staging work-up including bilateral mammography and/or breast MRI with ultrasound (men may have ultrasound only)
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- HER2-negative breast cancer or HER2-positive, hormone receptor-negative breast cancer
- Need for immediate neoadjuvant chemotherapy (e.g., inflammatory breast cancer)
- Evidence of stage IV cancer
- Prior excisional biopsy, lumpectomy, or lymph node surgery before study entry
- Prior chemotherapy, endocrine therapy, or radiation before study except limited endocrine therapy up to 28 days prior
- History of breast cancer unless disease-free >5 years and low risk of recurrence
- History of other treated malignancies with high recurrence risk or ongoing treatment
- Known hypersensitivity to study drugs or components
- Diagnosed diabetes mellitus type I or uncontrolled type II
- Immunocompromised due to HIV or immunosuppressive therapy
- Active liver disease or viral hepatitis
- Active inflammatory bowel disease or bowel inflammation
- Ocular conditions requiring treatment or active eye infections
- Pneumonitis or interstitial lung disease
- Significant heart disease or uncontrolled hypertension
- Damaged skin at injection sites
- Recent thromboembolism with unstable anticoagulation
- Use of chronic corticosteroids started less than 6 months ago or other prohibited medications
- Participation in another clinical trial with investigational drugs within 30 days
- Pregnancy or lactation at randomization
- Significant neurological or psychiatric disorders interfering with consent or study participation
- Any condition interfering with study evaluation or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
KEM Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany, 45136
Actively Recruiting
2
Hämatologie-Onkologie im Zentrum MVZ GmbH
Augsburg, Germany, 86150
Actively Recruiting
3
DBZ Onkologie
Berlin, Germany, 12623
Not Yet Recruiting
4
Praxisklinik Krebsheilkunde für Frauen
Berlin, Germany, 13597
Actively Recruiting
5
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany, 33604
Actively Recruiting
6
Department of Breast-Center Holweide - Kliniken der Stadt Köln
Cologne, Germany, 51067
Actively Recruiting
7
Städtisches Klinikum Dessau
Dessau, Germany, 06847
Not Yet Recruiting
8
University Hospital Carl Gustav Carus
Dresden, Germany, 01307
Actively Recruiting
9
Center for Gynecologic Oncology
Düsseldorf, Germany, 40235
Actively Recruiting
10
Frauenklinik des Universitätsklinikums Erlangen
Erlangen, Germany, 91054
Not Yet Recruiting
11
Klinik für Gynäkologie und Geburtshilfe Agaplesion Markus Krankenhaus
Frankfurt, Germany, 60431
Actively Recruiting
12
SRH Wald-Klinikum Gera GmbH
Gera, Germany, 07548
Actively Recruiting
13
Mammazentrum HH am Krankenhaus Jerusalem
Hamburg, Germany, 20357
Actively Recruiting
14
Klinikum Hanau
Hanau, Germany, 63450
Not Yet Recruiting
15
DIAKOVERE Henriettenstift Frauenklinik
Hanover, Germany, 30171
Not Yet Recruiting
16
National Center for Tumor Diseases - University Hospital Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
17
Elisabeth Krankenhaus Brustzentrum
Kassel, Germany, 34117
Actively Recruiting
18
Praxis für Hämatologie und Onkologie Koblenz and InVo - Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, Germany, 56068
Actively Recruiting
19
University Hospital Mannheim
Mannheim, Germany, 68167
Not Yet Recruiting
20
University Hospital Gießen and Marburg, Campus Marburg
Marburg, Germany, 35043
Not Yet Recruiting
21
Media Vita GmbH (MVZ)
Münster, Germany, 48145
Not Yet Recruiting
22
University Hospital Tübingen
Tübingen, Germany, 72076
Actively Recruiting
23
Department of Gynecology and Obstetrics - University of Ulm
Ulm, Germany, 89075
Not Yet Recruiting
24
GRN Klinik Weinheim
Weinheim, Germany, 69469
Not Yet Recruiting
25
Klinikum Worms
Worms, Germany, 67550
Not Yet Recruiting
26
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany, 42283
Actively Recruiting
27
Università Politecnica delle Marche - Azienda Ospedaliero Universitarià delle Marche
Ancona, Italy
Not Yet Recruiting
28
AULSS9 Scaligera - Ospedale Mater Salutis di Legnago
Legnago, Italy, 37045
Not Yet Recruiting
29
Istituto Europeo di Oncologica
Milan, Italy, 20141
Actively Recruiting
Research Team
J
Jana Roßney
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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