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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT06441890
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Dec 5, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Treatment Arm
    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

Primary Outcome Measure

Number of participants that have a pathological complete response (pCR) [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IllinoisChicagoIllinois60612
Kent Hoskins, MD
[email protected]
312-355-0496
Mercedes Carrasquillo, BS
[email protected]
3124131902

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Illinois· Chicago, IL

Related Studies