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

NCT06441890 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2023-1384
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; HER2-positive Breast Cancer

Outcome Measures

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

  16 weeks

Secondary Outcomes (7)

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

  Baseline

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

  30 days post treatment

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

  6 months post treatment

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

  30 days post treatment

• Treatment tolerability will be assessed

  30 days post treatment

Study Arms (1)

Single Treatment Arm

OTHER

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

Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Docetaxel; Drug: Trastuzumab; Drug: Pertuzumab

Interventions

Paclitaxel DRUG

80mg/m2 IV D1, 8, 15

Single Treatment Arm

Nab-paclitaxel DRUG

125mg/m2 IV D1, 8, 15

Single Treatment Arm

Docetaxel DRUG

75mg/m2 IV D1

Single Treatment Arm

Trastuzumab DRUG

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

Single Treatment Arm

Pertuzumab DRUG

840 mg loading, then 420mg IV/SQ D1

Single Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• HER2-enriched subtype on the MammaPrint/BluePrint gene expression profile within 90 days prior to study registration.
• Curative resection of primary breast tumor(s) is planned; ipsilateral axillary nodes will be sampled by sentinel lymph node biopsy or axillary dissection
• Treating Oncologist recommends neoadjuvant chemotherapy
• No evidence of distant metastatic disease
• AJCC clinical stage: cT1c-T3, cN0-N2
• Baseline left ventricular ejection fraction (LVEF) of at least 50% on Echo or MUGA scan within 90 days prior to registration.
• Adequate organ function as defined below:
• Leukocytes ≥2,000/mm3 Platelet count ≥ 75,000/mm3 Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 Hemoglobin (Hgb) ≥ 9.0 g/dL Creatinine/Calculated Creatine clearance (CrCI) Cr \< 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL/min using the Cockcroft-Gault formula Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin \> 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN
• Patients with synchronous bilateral primary breast tumors or multiple ipsilateral primary breast tumors are eligible if the treating Oncologist determines that the assigned treatment regimen is appropriate therapy for all primary tumors requiring chemotherapy.
• Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. or the Legally Authorized Representative (LAR) is able to provide consent and HIPAA authorization.
• Women of childbearing potential must agree to use a barrier form of contraception if they are sexually active with a male partner and cannot be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.

You may not qualify if:

• 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.
• Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
• Other major comorbidity (e.g., compromised liver function, major cardiovascular or cerebrovascular event within the past 6 months, uncontrolled diabetes mellitus or hypertension), as determined by treating physician.
• Any contraindication for any chemotherapy drug used in the assigned regimen.
• Baseline sensory neuropathy \> grade 1
• History of hypersensitivity to any of the drugs in the treatment regimen. Patients with history of hypersensitivity may be treated on this protocol with either nab-paclitaxel or docetaxel.
• Prisoners

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; 130-nm albumin-bound paclitaxel; Docetaxel; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

kent hoskins

CONTACT

3123550496; khoski@uic.ed

Mercedes Carrasquillo, BS

CONTACT

3124131902; micarras@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (1)