Health TrialsbyHealthPanel

BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer

ConditionsBreast CancerHER2-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years of age at time of consent

ECOG performance status 0, 1, or 2

Histologically confirmed invasive breast cancer documented by core needle or surgical biopsy with 90 days prior to study registration.

HER2-positive by IHC or FISH according to ASCO/CAP 2018 guidelines

Disqualifiers

Any prior therapy for this breast cancer

Active infection requiring systemic therapy at the time of study registration

Pregnant or nursing

Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.

Trial design

Design model

Single group

Treatments tested in this trial

  • Paclitaxel

    Drug

    80mg/m2 IV D1, 8, 15

  • Nab-paclitaxel

    Drug

    125mg/m2 IV D1, 8, 15

  • Docetaxel

    Drug

    75mg/m2 IV D1

  • Trastuzumab

    Drug

    8mg/kg loading, then 6mg/kg IV/SQ D1

  • Pertuzumab

    Drug

    840 mg loading, then 420mg IV/SQ D1

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Single Treatment ArmOther 5 interventions

Trial outcomes

Primary outcomes

1

Number of participants that have a pathological complete response (pCR)

This is defined as the absence of any residual invasive carcinoma on hematoxylin and eosin evaluation of the resected breast specimen and any resected lymph node tissue

Time frame
16 weeks

Secondary outcomes

1

Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires

Number of participants having good outcome versus low outcomes. High score means worse health outcomes and low score means better health outcomes

Time frame
Baseline
2

Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires

Number of participants having good outcome versus low outcomes. High score means worse health outcomes and low score means better health outcomes

Time frame
30 days post treatment
3

Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires

Number of participants having good outcome versus low outcomes. High score means worse health outcomes and low score means better health outcomes

Time frame
6 months post treatment
4

Safety of the study treatment with be assessed by evaluating the number of participants experiencing Adverse Events (AEs)

AEs will be evaluated using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5

Time frame
30 days post treatment

Other outcomes

Sponsors and contacts

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

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov
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