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Anti-metabolites
Neoadjuvant Therapy for Breast Cancer (BRE-10 Trial)
Phase 2
Recruiting
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HER2-positive by IHC or FISH according to ASCO/CAP 2018 guidelines
No evidence of distant metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post treatment
Awards & highlights
Summary
This trial will test a new test called MammaPrint®/BluePrint® on men and women with early-stage HER2-positive breast cancer to help with treatment decisions.
Who is the study for?
This trial is for adults over 18 with early-stage HER2-positive breast cancer, as confirmed by specific tests. They should be fit enough for chemotherapy and surgery to remove the breast tumor and examine nearby lymph nodes. There must be no signs of cancer spread elsewhere in the body.
What is being tested?
The study is testing how well different chemotherapy drugs (Docetaxel, Trastuzumab, Pertuzumab, Paclitaxel, Nab-paclitaxel) work before surgery in patients whose tumors have a certain genetic profile indicating they are likely to respond to treatment.
What are the potential side effects?
Common side effects of these drugs include fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is HER2-positive based on specific tests.
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My cancer has not spread to distant parts of my body.
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I can care for myself and am up and about more than 50% of my waking hours.
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My breast cancer is at an early but not the earliest stage and may have spread to nearby lymph nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants that have a pathological complete response (pCR)
Secondary outcome measures
Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires
Safety of the study treatment with be assessed by evaluating the number of participants experiencing Adverse Events (AEs)
Treatment tolerability will be assessed
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Treatment ArmExperimental Treatment5 Interventions
One of the following Taxane options below per physician's choice
* Paclitaxel 80mg/m2 IV D1, 8, 15 Q21 days
* Nab-paclitaxel1 125mg/m2 IV D1, 8, 15 Q21 days
* Docetaxel1 75mg/m2 IV D1 Q-21 days
* Trastuzumab2 8mg/kg loading, then 6mg/kg IV/SQ D1 Q21 days
* Pertuzumab2 840 mg loading, then 420mg IV/SQ D1 Q21 days
* 1 may be substituted for paclitaxel for patients intolerant to paclitaxel or the steroid premed regimen, or at investigator discretion
* 2 Pertuzumab, trastuzumab, and hyaluronidase injection for subcutaneous use may be substituted with dose per package insert
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Nab-paclitaxel
2014
Completed Phase 3
~1950
Paclitaxel
2011
Completed Phase 4
~5810
Docetaxel
1995
Completed Phase 4
~5620
Pertuzumab
2014
Completed Phase 3
~7500
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
632 Previous Clinical Trials
1,567,687 Total Patients Enrolled
11 Trials studying Breast Cancer
1,342,356 Patients Enrolled for Breast Cancer
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