Is NCT05035836 recruiting in Houston, TX?

Yes, NCT05035836 is currently recruiting participants at its Houston, TX location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Breast Cancer Clinical Trial in Houston, TX

About This Breast Cancer Study in Houston

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) .

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion 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 drug.

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 subjects must agree not to donate sperm and female subjects must agree not to donate oocytes starting at screening and throughout the study period, and for at least 12 months after treatment discontinuation.

Patient with reproductive potential must have a negative pregnancy test ≤3 days prior to the first dose of zanidatamab.

Exclusion Criteria

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 efficacy 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 limit compliance with study requirements or compromise the ability of the patient to give written informed consent.

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 uncontrolled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications).

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: Subjects who are currently or have previously been on any of the following steroid regimens are not excluded:

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 allergen)

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 subjects with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment)

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 administration.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT05035836) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Breast Cancer Treatment Options in Houston, TX

If you're searching for breast cancer treatment options in Houston, TX, this clinical trial (NCT05035836) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all breast cancer clinical trials near you to find additional studies recruiting in your area.

Breast Cancer Clinical Trial in Houston, TX

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