Is NCT06008275 recruiting in Dallas, TX?

Yes, NCT06008275 is currently recruiting participants at its Dallas, TX location. This metastatic triple-negative breast carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Dallas 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.

Metastatic Triple-Negative Breast Carcinoma Clinical Trial in Dallas, TX

Q: How do I join the metastatic triple-negative breast carcinoma clinical trial in Dallas?

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

About This Metastatic Triple-Negative Breast Carcinoma Study in Dallas

The goal of this clinical trial is to assess the safety and efficacy of combined ruxolitinib and neratinib in patients with chemotherapy-pretreated metastatic triple negative breast cancer. This trial will evaluate one dosing schedule of neratinib in ruxolitinib in patients with metTNBC with locoregional recurrence.

Sponsor: Baylor Research Institute

Who Can Participate

Inclusion Criteria

A patient will be considered for enrollment in this study if all the following criteria are met:

Female patients ≥18 years of age

Have a diagnosis of metastatic TNBC previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy, unless there was a contraindication to doxorubicin, in which case prior treatment with this agent is not required. Note. TNBC defined as ER-negative tumors with ≤10% tumor nuclei immunoreactivity, or "ER Low Positive" as defined by the updated ASCO/CAP guidelines 2020.

Have not received more than 4 prior chemotherapy regimens for metastatic disease. Prior platinum and/or taxane therapy in the adjuvant or metastatic setting is permitted. Patients with more than 4 prior regimens may be allowed on study per physician discretion, if ECOG PS is 0-1.

Have locoregional (e.g., breast, chest wall, regional lymphatic) or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy. If a research biopsy from a patient's metastatic disease cannot be safely obtained, a skin biopsy is permitted. If a skin biopsy cannot be safely obtained, patients may still be eligible, per physician discretion.

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Have adequate hematologic function, defined by:

Absolute neutrophil count (ANC) \>1500/µL

Platelet count ≥100,000/ µL

Hemoglobin ≥9 g/dL or ≥5.6 mmol/L

Have adequate liver function, defined by:

AST and ALT ≤2.5 x the upper limit of normal (ULN) or ≤5 x ULN in presence of liver metastases

Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5 × ULN

Have adequate renal function, defined by: a. Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL/min

Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:

Brain metastases which have been treated

Off-treatment with steroids before administration of the first dose of treatment

No ongoing requirement for dexamethasone or anti-epileptic drugs

No clinical or radiological evidence of progression of brain metastases

Patients must be accessible for treatment and follow-up.

All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.

Exclusion Criteria

A patient will be ineligible for inclusion in this study any of the following criteria are met:

Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment. Administration of killed vaccines is allowed.

Has peripheral neuropathy ≥grade 2

Has completed previous radiotherapy for metastatic disease \<2 weeks prior to study treatment initiation

Has an active infection requiring systemic therapy

Has significant cardiovascular disease, such as:

History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the last 6 months

Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA class III or IV.

Has a known history of active tuberculosis

Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.

Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:

severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air

liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's full participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Treating Physician.

Has received prior systemic anti-cancer therapy within 2 weeks prior to study treatment.

Has received investigational agents within 4 weeks prior to study treatment. Monoclonal antibody agents should have a 4-week (28 day) washout period.

Any other investigational or anti-cancer treatments while participating in this study

Any other active malignancy

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 Dallas?

Yes, this clinical trial (NCT06008275) has an active research site in Dallas, 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.

Metastatic Triple-Negative Breast Carcinoma Treatment Options in Dallas, TX

If you're searching for metastatic triple-negative breast carcinoma treatment options in Dallas, TX, this clinical trial (NCT06008275) 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 Dallas research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic triple-negative breast carcinoma 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 metastatic triple-negative breast carcinoma clinical trials near you to find additional studies recruiting in your area.

Metastatic Triple-Negative Breast Carcinoma Clinical Trial in Dallas, TX

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