Trial Title:
A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
NCT ID:
NCT06274515
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Tumor Tissue and Blood Draw
Description:
Participants will have their blood drawn on the day a tissue sample is taken from a
progressive tumor lesion.
Arm group label:
Mechanisms of Acquired Resistance
Arm group label:
Mechanisms of Primary Resistance
Summary:
This study will evaluate mechanisms of resistance to anti-breast cancer therapies in
tumor and blood samples from participants with human epidermal growth factor receptor
(HER2) positive, hormone receptor (HR) positive or triple negative breast cancer.
Criteria for eligibility:
Criteria:
General Inclusion Criteria:
- Willingness to undergo a procedure to obtain tumor tissue (e.g. biopsy) and blood
draw
- Diagnosis of HER2+, HR+ (for cohort R1) or triple negative breast cancer (for cohort
T1) as per local assessment
- Availability of an archival tumor tissue (most recent pre-treatment tumor tissue is
preferred)
- Unequivocally growing tumor lesion (progressive lesion) that is accessible for
resection, excision or core needle biopsy
- Discontinuation of prior anti-cancer treatment outlined below should not be longer
than 4 weeks from participation in this study
Inclusion criteria for participants in the cohorts studying acquired resistance
- Participant had undergone regular monitoring for disease progression as per local
practice (preferably every 3-6 months) while on most recent breast cancer therapy
- Accessible tumor lesion that newly appeared or a lesion that started to regrow while
the participant was at least 6 months on therapy
Inclusion criteria for participants in the cohort studying primary resistance
- Accessible tumor lesion that continued to increase in size or a newly appearing
lesion (as confirmed by routine tumor assessment) while treated for at least 4 weeks
but less than 6 months on therapy
Exclusion Criteria:
- Any risks factors that increase the risk of complications associated with the
procedure to obtain tumor tissue (e.g. bleeding disorders)
- Any serious medical condition or abnormality in clinical laboratory tests that
precludes an individual's safe participation in and completion of the study
- Participant has started treatment with subsequent anti-cancer therapy
- Participants whose progressive tumor lesion that is targeted for biopsy/resection is
in the bone
- Discontinuation of treatment was due to a reason other than disease progression
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Jules Bordet
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Status:
Recruiting
Facility:
Name:
CHU Sart-Tilman
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
AZ Delta (Campus Rumbeke)
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Aalborg Universitetshospital; Onkologisk Afdeling
Address:
City:
Aalborg
Zip:
9000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Sjællands Universitetshospital, Næstved; Onkologisk Afdeling
Address:
City:
Naestved
Zip:
4700
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Helsinki University Central Hospital; Dept of Oncology
Address:
City:
Helsinki
Zip:
00029
Country:
Finland
Status:
Recruiting
Facility:
Name:
Tampere University Hospital; Dept of Oncology
Address:
City:
Tampere
Zip:
33520
Country:
Finland
Status:
Recruiting
Facility:
Name:
KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie
Address:
City:
Essen
Zip:
45136
Country:
Germany
Status:
Recruiting
Facility:
Name:
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
Address:
City:
Karlsruhe
Zip:
76135
Country:
Germany
Status:
Recruiting
Facility:
Name:
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Address:
City:
Koeln
Zip:
50935
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Mannheim; Frauenklinik
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Recruiting
Facility:
Name:
I.R.S.T Srl IRCCS; Oncologia Medica
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero - Universitaria di Modena Policlinico
Address:
City:
Modena
Zip:
41110
Country:
Italy
Status:
Recruiting
Facility:
Name:
RCCS - Centro di Riferimento; Oncologia Medica B
Address:
City:
Aviano (PN)
Zip:
33081
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Raffaele S.r.l. - PPDS
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
Oslo universitetssykehus HF, Ullevål, Kreftsenteret
Address:
City:
Oslo
Zip:
0450
Country:
Norway
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
HM Sanchinarro ? CIOCC; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Basingstoke and North Hampshire Hospital
Address:
City:
Basingstoke
Zip:
RG24 9NA
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Imperial College Healthcare NHS Trust;Medical Oncology
Address:
City:
London
Zip:
W6 8RF
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Christie Hospital NHS Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Start date:
April 2, 2024
Completion date:
January 28, 2027
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06274515
