BridgeMD
New treatment option for HER2-positive Early-stage Breast Cancer
Official title Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer
ClinicalTrials.gov ID: NCT07402473
What this study is testing
What is Trastuzumab?
Trastuzumab is an investigational medicine, being studied as a potential treatment for her2-positive early-stage 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
- This is an open-label phase 2 study to evaluate the pCR rate in patients diagnosed with HER2 positive breast cancer treated on an adaptive clinical trial design. Tumors will undergo testing using a novel molecular phosphoprotein-based biomarker assay, HER2 Activation Response Predictive Signature (HARPS) to identify HARPS-positive breast cancers.
- 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 to 90
You may be able to join if
- 1. Tumor size greater than 2cm or lymph node positive by imaging or clinical exam (cT2-T3 N0-2)
- Tumors must be HER2 positive either by IHC (3+) or by IHC 2+ and FISH positive.
- Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status locally determined prior to study entry
- Patient must have adequate tumor for HARPS testing.
- Patients must have ctDNA collection prior to treatment on trial.
You likely can't join if
- Previous treatment with chemotherapy, anti-HER2 therapy, radiation therapy, or endocrine therapy for invasive breast cancer. Exception: patients can...
- cT4 and/or cN3 tumors
- Evidence of metastatic disease by routine clinical assessment
- Bilateral breast cancer
- History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and...
- Left ventricular ejection fraction (LVEF) below 50% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO)
See the full eligibility criteria
- 1. Tumor size greater than 2cm or lymph node positive by imaging or clinical exam (cT2-T3 N0-2)
- Tumors must be HER2 positive either by IHC (3+) or by IHC 2+ and FISH positive.
- Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status locally determined prior to study entry
- Patient must have adequate tumor for HARPS testing.
- Patients must have ctDNA collection prior to treatment on trial.
- Patient must be able to do breast MRI as determined by the study
- Baseline LVEF \> 50% (Most recent within the last 5 years)
- No prior history of systemic treatment with anthracyclines-based chemotherapy.
- Adequate bone marrow function:
- ANC ≥ 1500/uL
- platelet count ≥ 100,000/uL
- hemoglobin ≥ 9.0 g/dL
- Adequate hepatic function:
- Total bilirubin ≤ 1.5 X ULN
- AST (SGOT) ≤ 5 X ULN
- ALT (SGPT) ≤ 5 X ULN
- Patients with biliary obstruction must have restored biliary flow by placement of an endoscopic common bile duct stent or a percutaneous drainage.
- Adequate renal function, Creatinine \< 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula.
- Ability to understand the nature of this study protocol and give written informed consent.
- Willingness and ability to comply with scheduled visits and treatment plans
- Prior cancers allowed if no evidence of disease in last 5 years. Prior history of ipsilateral invasive breast cancers are not allowed.
- Previous treatment with chemotherapy, anti-HER2 therapy, radiation therapy, or endocrine therapy for invasive breast cancer. Exception: patients can start upto 1 cycle of HP prior to starting treatment on study.
- cT4 and/or cN3 tumors
- Evidence of metastatic disease by routine clinical assessment
- Bilateral breast cancer
- History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and squamous cell carcinoma of the skin and/or in situ cervical carcinoma
- Left ventricular ejection fraction (LVEF) below 50% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO)
- No active liver disease.
- Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study.
- Pre-existing sensory neuropathy \> grade 1.
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
- Serious non-healing wound, ulcer, or bone fracture
- Patient with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C.
- Patient who has a history of allergy or hypersensitivity to any of the study drugs.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
The study team makes the final eligibility decision.
Where it's taking place
- Elizabeth, New Jersey, United States
- Hamilton, New Jersey, United States
- Long Branch, New Jersey, United States
- New Brunswick, New Jersey, United States
- Newark, New Jersey, United States
- Somerville, New Jersey, United States
- Toms River, New Jersey, 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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elizabeth, New Jersey, United States; Hamilton, New Jersey, United States; Long Branch, New Jersey, United States; New Brunswick, New Jersey, United States; Newark, New Jersey, United States; Somerville, New Jersey, United States and 1 more location(s). 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.