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Looking for participantsPhase4

A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

Sponsor: Hoffmann-La Roche

NCT ID: NCT06274515

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Tumor Tissue and Blood Draw (procedure)
How long the study runs
Study runs about 44 months (dates as stated)
About the drug or intervention
Tumor Tissue and Blood Draw — procedure: Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
320
Started
2024-04-02
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer
  • • Phase4 - 320 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast cancer

Where?

  • • Basingstoke - Basingstoke and North Hampshire Hospital
  • • London - Imperial College Healthcare NHS Trust
  • • Manchester - Christie Hospital NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Breast Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2triple negative

What the study is looking for

  • ✓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...

Who cannot take part

  • ✗Any risks factors that increase the risk of complications associated with the procedure to obtain tumor tissue (e.g....
  • ✗Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe...
  • ✗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
See the full 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

Where Is This Study? (3 UK sites)

Basingstoke and North Hampshire Hospital

Basingstoke RG24 9NA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Manager

research.team@hhft.nhs.uk01256 473202 Ext 4557

Imperial College Healthcare NHS Trust

London W6 8RF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Christie Hospital NHS Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Reference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10