Is NCT04265872 recruiting in Dallas, TX?

Yes, NCT04265872 is currently recruiting participants at its Dallas, TX location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer 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.

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.

Breast Cancer Clinical Trial in Dallas, TX

About This Breast Cancer Study in Dallas

The hypothesis of this pilot trial is that administration of bortezomib will inhibit NHEJ in metastatic TNBC leading at the time of disease progression to metastases that are HR-deficient and sensitive to pembrolizumab and cisplatin therapy. The trial will include in depth analysis of the patients' TNBC genome and phosphoproteome to evaluate HR-proficiency and deficiency, and nuclear proteins that drive NHEJ, before and upon progression with bortezomib therapy.

Sponsor: Baylor Research Institute

Who Can Participate

Inclusion Criteria

A patient will be eligible for inclusion in this study if she meets all of the following criteria:

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 \< or = 10% tumor nuclei immunoreactivity, or "ER Low Positive" as defined by the updated ASCO/CAP guidelines 2020.

Have not received more than 3 prior chemotherapy regimens for metastatic disease. Prior platinum and/or taxane therapy in the adjuvant or metastatic setting is permitted.

Have locoregional (eg, 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 (See Appendix I)

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

Have adequate coagulation function, defined by:

International Normalized Ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN.

If patient is receiving anticoagulant therapy, PT or aPTT must be within therapeutic range of intended use of anticoagulants.

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 for 2 weeks before administration of the first dose of bortezomib

No ongoing requirement for dexamethasone or anti-epileptic drugs

No clinical or radiological evidence of progression of brain metastases

Patient 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

Has received a live vaccine within 30 days of the first dose of study treatment. NOTE: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (ie, FluMist ®) are live attenuated vaccines, and are not allowed.

Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy.

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.

Has a known history of Human Immunodeficiency Virus (HIV)

Has known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection

Has a history of non-infectious pneumonitis that required steroids or current pneumonitis

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 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 including investigational agents within 4 weeks prior to study treatment (this would not include bortezomib while on study). 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 (NCT04265872) 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.

Breast Cancer Treatment Options in Dallas, TX

If you're searching for breast cancer treatment options in Dallas, TX, this clinical trial (NCT04265872) 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 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 Dallas, TX

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