Health Trials

A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tumor Tissue and Blood Draw

    Procedure/Surgery

    Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Mechanisms of Acquired ResistanceExperimental treatment 1 intervention
Group B: Mechanisms of Primary ResistanceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2)

Time frame
At least 6 months
2

Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2)

Time frame
At least 6 months
3

Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2)

Time frame
At least 6 months
4

Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3)

Time frame
Less than 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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