RecruitingPhase 2

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

BRE-10: BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer: The INNOVATE Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at using tumor gene tests to guide breast cancer treatment before surgery. It is for adult men and women with early-stage, HER2-positive breast cancer, which has high levels of a protein called HER2. A MammaPrint/BluePrint test will be done on the biopsy sample as part of usual care.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to care for yourself for most of the day, even if you cannot work.
  • Have breast cancer confirmed by a biopsy within 90 days before joining. Tests must show HER2-positive cancer and a HER2-enriched gene pattern.
  • Have cancer within the study’s allowed stages (cT1c–T3, cN0–N2), with no spread to distant parts of the body.
  • Have surgery planned to remove the cancer and check nearby underarm lymph nodes. Your cancer doctor must recommend chemotherapy before surgery.
  • Have heart pumping strength of at least 50% on a scan within 90 days before joining. Blood counts, kidney tests, and liver tests must meet study limits.
  • Be able to follow study steps. You or your legal representative must give written consent and permission to share health information.
  • If you could become pregnant, have a negative pregnancy test and use barrier birth control, such as condoms, when sexually active with a male partner.
  • Cancer in both breasts or several tumors may be allowed if the treatment fits all tumors. HIV or hepatitis B or C may be allowed if specific treatment, infection, and liver test rules are met.

Who can't join

  • Have already had treatment for this breast cancer.
  • Have an active infection needing medicine that works throughout the body, or be pregnant or breastfeeding.
  • Have another past or current cancer that could affect how the study treatment’s safety or results are judged.
  • Have a mental or medical condition that prevents consent or taking part, or be a prisoner.
  • Have another major health problem, such as poor liver function, a major heart or brain blood vessel event in the past 6 months, or uncontrolled diabetes or high blood pressure.
  • Have a medical reason you cannot safely receive a chemotherapy drug in your assigned treatment.
  • Have more than mild nerve damage that affects feeling, such as numbness or tingling.
  • Have had an allergic reaction to a study treatment drug. Some people with past reactions may still take part using nab-paclitaxel or docetaxel.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 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 Exclusion Criteria * 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

Study sites (1)

IL