Is NCT05868226 recruiting in Houston, TX?

Yes, NCT05868226 is currently recruiting participants at its Houston, TX location. This her2-positive breast cancer clinical trial is actively enrolling qualified participants.

How do I join the her2-positive 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.

HER2-positive Breast Cancer Clinical Trial in Houston, TX

About This HER2-positive Breast Cancer Study in Houston

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

Sponsor: QuantumLeap Healthcare Collaborative

Who Can Participate

Inclusion Criteria

GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).

GIC2: Age ≥ 18 years at the time of signing the informed consent

GIC3: Gender: Male or female (premenopausal and postmenopausal)

GIC4: ECOG performance status Grade 0-2

GIC5: Estimated life expectancy \> 12 weeks at the start of investigational medicinal product (IMP) treatment.

GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:

Absolute neutrophil count ≥ 1,500/mm3

Platelet count ≥ 100,000/mm3

Hemoglobin ≥ 9.0 g/dL with no blood transfusion in the past 28 days

Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN

Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL/min for small molecules and \>30 mL/min for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility. These cut-off values may be modified with supporting data for specific drug regimens.

GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.

GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository).

GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.

GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Additional arm specific inclusion criteria as needed by drug arm regimen General

Exclusion Criteria

GEC1: Wash out periods: No other anticancer therapy within the following periods:

chemotherapy or investigational agents, 3 weeks

mitomycin C and nitrosoureas, 6 weeks

radiotherapy, 3 weeks

targeted therapy, 2 weeks

MAbs, ADCs, and immunotherapy, 3 weeks

endocrine therapy, no washout needed

GEC2: Concurrent therapy with other Investigational Products.

GEC3: Prior history of drug/regimen hypersensitivity: History of infusion-related reactions and/or hypersensitivity to IMP or excipients of the study drug/drugs which led to permanent discontinuation of the treatment.

GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness/social situations that would limit compliance with study requirements).

GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.

GEC6: CNS tumoral spread: Active uncontrolled/symptomatic central nervous system cancer/spinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.

GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.

GEC8: Recent major surgery within 4 weeks prior to start IMP treatment

GEC9: Pregnancy or breastfeeding

GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.

GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.

GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.

Additional arm specific exclusion criteria as needed by drug arm regimen

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 (NCT05868226) 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.

HER2-positive Breast Cancer Treatment Options in Houston, TX

If you're searching for her2-positive breast cancer treatment options in Houston, TX, this clinical trial (NCT05868226) 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 her2-positive 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 her2-positive breast cancer clinical trials near you to find additional studies recruiting in your area.

HER2-positive Breast Cancer Clinical Trial in Houston, TX

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