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New treatment option for Breast Cancer
Official title BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer
ClinicalTrials.gov ID: NCT06441890
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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 how well it works assessment...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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 side...
- 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...
- 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...
- 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 how well it works assessment of this investigational regimen, as determined by the treating medical...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.