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New treatment option for Breast Cancer
Official title A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)
ClinicalTrials.gov ID: NCT05035836
What this study is testing
What is Zanidatamab?
Zanidatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as ZW25.
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 a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC. The primary objective is to determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR) .
- 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, women only
You may be able to join if
- Ability to give written informed consent
- Age \> 18 years at time of study entry.
- Patient would be willing to undergo surgery is appropriate for surgery
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).
- Tumor size \> 1 cm to ≤ 3 cm assessed by ultrasound and clinically and radiographically node negative with no known metastatic disease.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Involvement in the planning and/or conduct of the study.
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of...
- Has received therapy for this current diagnosis of BC including investigational therapy, endocrine therapy, targeted therapy, or chemotherapy...
- Mean QT interval corrected for heart rate (QTc) ≥ 470 ms.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, active...
See the full eligibility criteria
- Ability to give written informed consent
- Age \> 18 years at time of study entry.
- Patient would be willing to undergo surgery is appropriate for surgery
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).
- Tumor size \> 1 cm to ≤ 3 cm assessed by ultrasound and clinically and radiographically node negative with no known metastatic disease.
- HER2+ BC as defined by American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines.31 Patients may have ER+ or ER- negative disease, as defined by ASCO-CAP guidelines.
- Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan, documented within 4 weeks prior to first dose of study...
- Adequate normal organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≥ 1500 per mm3)
- Platelet count ≥ 100 x 109/L (≥100,000 per mm3)
- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). The maximum allowable bilirubin is ≤ 2.5 x ULN for patients with Gilbert's disease.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
- Calculated glomerular filtration rate \>50 mL/min
- Patients must either be of non-reproductive potential or willing to undergo appropriate contraception. Male people must agree not to donate sperm and female people must agree not to donate oocytes starting at screening...
- Patient with reproductive potential must have a negative pregnancy test ≤3 days prior to the first dose of zanidatamab.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Involvement in the planning and/or conduct of the study.
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen
- Has received therapy for this current diagnosis of BC including investigational therapy, endocrine therapy, targeted therapy, or chemotherapy, surgery or radiation.
- Mean QT interval corrected for heart rate (QTc) ≥ 470 ms.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, active bleeding diatheses, , or psychiatric illness/social situations that would...
- Female patients who are pregnant, breast-feeding, or of reproductive potential who are not employing an effective method of birth control.
- Patients with uncontrolled seizures.
- Any major surgery for any reason, within 4 weeks of the enrollment. Portacath placement will be allowed.
- Clinically significant cardiac disease such as ventricular arrhythmia requiring therapy, , myocardial infarction, unstable angina (within 6 months prior to first dose of study drug), any history of cardiac failure, and...
- Known active Hepatitis B and/or Hepatitis C. Hepatitis testing is not required unless the patient has a history of Hepatitis B or C.
- Known to be HIV positive. HIV testing is not required for those patients who are not known to be positive.
- Total lifetime anthracycline load exceeding 360 mg/m2 doxorubicin or equivalent
- Any condition that requires systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days prior to randomization. Note: people who are...
- Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)
- Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption\\
- Short course (≤7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact...
- History of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation
- Known distant metastatic disease including (CNS) metastases, symptomatic CNS metastases, and leptomeningeal disease (LMD).
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of people with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator...
- Symptomatic pulmonary embolism ≤28 days
- Administered a live vaccine ≤4 weeks prior to randomization. Patients can get COVID vaccine that are not alive before ot during the study period, with 48 hours between vaccine administration and investigation agent...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.