Breast CancerPhase 2BRE-10NCT06441890
BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer
A Phase 2 study testing Paclitaxel, Nab-paclitaxel and Docetaxel in people with Breast Cancer and HER2-positive Breast Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Paclitaxel, Nab-paclitaxel and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
- Patients with history of HIV/AIDS (acquired immunodeficiency syndrome) are eligible for this study if they are receiving anti-retroviral therapy and it does not include any medications known to alter metabolism or tolerability of component drugs in the protocol treatment regimen and the following criteria is met:
- Patients without a history of AIDS-defining opportunistic infections within the past 12 months.
- Patients with Hepatitis B (HBV): chronic carriers of HBV infection (HBsAg-positive) or individuals who have serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HBc-positive) are eligible if they are receiving appropriate suppressive antiviral therapy that does not include medications known to alter metabolism or tolerability of component drugs in the protocol treatment (see Appendix) prior to initiation of cancer therapy, and liver function tests meet study eligibility criteria.
- Patients with Hepatitis C (HCV): patients with a history of HCV infection who have completed curative antiviral treatment are eligible if the HCV RNA viral load is below the limit of quantification within 90 days of study enrollment. Patients on concurrent HCV treatment must have HCV RNA viral load below the limit of quantification within 30 days of study enrollment. Patients must also meet liver function test eligibility requirements and antiviral therapy does not include medications known to alter metabolism or tolerability of component drugs in the protocol treatment
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Kent Hoskins, MD, 312-355-0496, khoski@uic.ed
Mercedes Carrasquillo, BS, 3124131902, micarras@uic.edu
About this study
Official title: BRE-10: BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer: The INNOVATE 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
Read the detailed description
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. Patients whose tumors have a HER2-enriched molecular subtype on the MammaPrint®/BluePrint® assay and are recommended for neoadjuvant chemotherapy by their treating Oncologist will be recruited for study enrollment
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Being tested
- Paclitaxel, Nab-paclitaxel, Docetaxel, Trastuzumab, Pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
80mg/m2 IV D1, 8, 15
Nab-paclitaxelDrug
125mg/m2 IV D1, 8, 15
DocetaxelDrug
75mg/m2 IV D1
TrastuzumabDrug
8mg/kg loading, then 6mg/kg IV/SQ D1
PertuzumabDrug
840 mg loading, then 420mg IV/SQ D1
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Docetaxel; Drug: Trastuzumab; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (7)
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
Measured: Baseline
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
Measured: 30 days post treatment
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
Measured: 6 months post treatment
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
Measured: 30 days post treatment
Treatment tolerability will be assessed
Number of participants that have cycle treatment delays
Measured: 30 days post treatment
Treatment tolerability will be assessed
Number of participants that have cycle treatment cancelations
Measured: 30 days post treatment
Treatment tolerability will be assessed
Number of participants that have dose reductions
Measured: 30 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start5 Dec 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kent F. Hoskins, MD, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441890
- Sponsor's protocol ID
- 2023-1384
- Acronym
- BRE-10
- Status last verified
- Aug 2026
- First submitted
- 29 May 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRE-10: BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer: The INNOVATE Trial
- ClinicalTrials.gov ID
- NCT06441890
- Acronym / sponsor ID
- BRE-10 / 2023-1384
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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. Patients whose tumors have a HER2-enriched molecular subtype on the MammaPrint®/BluePrint® assay and are recommended for neoadjuvant chemotherapy by their treating Oncologist will be recruited for study enrollment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Treatment Arm | Other | Drug: Paclitaxel, Drug: Nab-paclitaxel, Drug: Docetaxel, Drug: Trastuzumab, Drug: PertuzumabOne 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel80mg/m2 IV D1, 8, 15 | Drug | Single Treatment Arm |
| Nab-paclitaxel125mg/m2 IV D1, 8, 15 | Drug | Single Treatment Arm |
| Docetaxel75mg/m2 IV D1 | Drug | Single Treatment Arm |
| Trastuzumab8mg/kg loading, then 6mg/kg IV/SQ D1 | Drug | Single Treatment Arm |
| Pertuzumab840 mg loading, then 420mg IV/SQ D1 | Drug | Single Treatment Arm |
Primary outcome
Number of participants that have a pathological complete response (pCR)
Time frame: 16 weeks
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
7 secondary outcomes
Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires
Time frame: Baseline
Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires
Time frame: 30 days post treatment
Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires
Time frame: 6 months post treatment
Safety of the study treatment with be assessed by evaluating the number of participants experiencing Adverse Events (AEs)
Time frame: 30 days post treatment
Treatment tolerability will be assessed
Time frame: 30 days post treatment
Treatment tolerability will be assessed
Time frame: 30 days post treatment
Treatment tolerability will be assessed
Time frame: 30 days post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Nab-paclitaxel and Docetaxel in people with Breast Cancer and HER2-positive Breast Cancer, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kent hoskins (3123550496, khoski@uic.ed), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that have a pathological complete response (pCR) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.