No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
320 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for
This trial is looking for people with certain types of breast cancer to help understand why some therapies don't work. Participants will provide tumor and blood samples and may need a biopsy or other procedure.
Are You a Good Fit for This Trial?
You may be able to join if
I am willing to have a biopsy and blood drawn.
I have been diagnosed with HER2 positive, hormone receptor positive, or triple negative breast cancer.
I have recent archival tumor tissue available.
I have a growing tumor that can be biopsied.
I stopped my previous cancer treatment no more than 4 weeks ago.
I have been monitored for disease progression while on treatment.
I have a new or regrowing tumor after at least 6 months of therapy.
You may not be able to join if
I have a bleeding disorder or other risk factors for complications.
I have a serious medical condition that prevents safe participation.
I have started any new cancer treatment.
My tumor for biopsy is in the bone.
I stopped treatment for a reason other than disease progression.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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-treatme…
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
Contacts
Reference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
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