Is NCT02422641 recruiting in Baltimore, MD?

Yes, NCT02422641 is currently recruiting participants at its Baltimore, MD location. This breast cancer clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Baltimore, 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 Baltimore 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 Baltimore, MD

About This Breast Cancer Study in Baltimore

Management of leptomeningeal disease (LMD) in patients with metastatic breast cancer is an area of unmet clinical need. High-dose methotrexate (HD-MTX) is known to have activity against breast cancer and in contrast to other systemic chemotherapeutics, it penetrates the blood brain barrier, targets areas of poor cerebrospinal fluid flow, may penetrate bulky leptomeningeal disease, and provide treatment to systemic disease burden. While two retrospective studies have suggested activity of HD-MTX

Sponsor: Wake Forest University Health Sciences

Who Can Participate

Inclusion Criteria

Adults (male and female) age \>18

Eastern Cooperative Group (ECOG) Performance Scale 0-1 (see Appendix I)

Histologically or cytologically confirmed invasive breast cancer of the following subtype:

TRIPLE NEGATIVE (ER-negative, PR-negative, and HER2-negative disease). Triple-negative patients will be defined per ASCO-CAP Guidelines.

HER2-POSITIVE: HER2-positive patients will be defined per ASCO-CAP Guidelines.

HORMONE REFRACTORY: Patients with ER/PR-positive disease according to ASCO-CAP guidelines above may be considered if they have disease progression after two lines of hormonal therapy (administered in the adjuvant or metastatic setting), or are deemed clinically hormone-resistant taking into consideration the rate of progression of disease or a short interval of time on first line hormonal therapy before progression. Clinically hormone-resistant patients MUST also be discussed with the Study Chair, Study co-chair or designee in advance for approval. NOTE: ASCO-CAP guidelines state that ER and PR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. HER2-positive is defined as HER2 IHC 3+, ISH ≥ 2.0, or average HER2 copy number ≥ 6.0 signals. NOTE: A patient who has a change in receptor status (e.g. PR negative to positive) may be stratified as triple negative or hormone positive, contrary to the most recent receptor testing, for the purposes of the study, based upon the clinical course at the discretion of the Study Chair, Study co-chair, or designee in advance for approval.

Cytologic or unequivocal radiographic confirmation of leptomeningeal metastasis by dural puncture and/or neuroimaging with or without known brain metastasis

Adequate organ function as follows: Estimated creatinine clearance \>70 cc/min (calculated by Cockcroft-Gault formula) White blood cell counts \>3000 cells/mcL Absolute neutrophil count \>1500 cells/mcL Platelet count \>100,000 cells/mcL Hematocrit \>30% Serum bilirubin \<1.5 x the ULN or \<5x the ULN if secondary to liver metastasis Alanine aminotransferase or aspartate aminotransferase \<2.5x the ULN or \<5x the ULN if secondary to liver metastasis Alkaline phosphatase \<2.5x the ULN or \<5x the ULN if secondary to liver metastasis \- Able to provide confirmed consent

Exclusion Criteria

Prior allergy or adverse reaction to methotrexate

New York Heart Association Heart Failure Class \>3

Active diabetes insipidus

Active mucositis

Chemotherapy or stereotactic radiotherapy within the last 2 weeks

Partial brain radiotherapy (i.e. \<40% of total brain volume) within the last 2 weeks

Whole brain radiotherapy within the last 6 months or partial brain radiotherapy exceeding \>40% of total brain volume within the last 6 months

Prior treatment with any methotrexate containing systemic regimen within 1 year (excluding intrathecal methotrexate)

Concurrent or planned systemic chemotherapy, radiotherapy, new hormonal or anti- HER2 directed therapy directed at management of breast cancer (existing anti-HER2 therapy can be continued as recently recommended in the National Consensus Guidelines (26)

Uncontrolled or progressive systemic disease or other concurrent condition which in the Investigator's opinion makes HD-MTX an undesirable treatment option for the patient or would jeopardize compliance

Contraindication to MRI

Use of salicylates, non-steroidal anti-inflammatory drugs, or sulfonamide medications within one week of start of methotrexate

Pregnant women or women who are breastfeeding.

Patients with significant visceral fluid collections including ascites, pericardial effusions, pleural effusions or others may experience delayed clearance of methotrexate because of third space accumulation which could result in methotrexate toxicity and inability to tolerate the proposed study treatment. While these are not absolute exclusions the Study Chair or co-Chairs should be contacted to discuss possible enrollment. Patients with significant ascites defined as European Association for the Study of the Liver \> grade 2 (Appendix IV), or with asymptomatic pleural effusions with an estimated size \>200 mL, or with symptomatic pleural effusion of any size will be excluded. NOTE: Systemic staging of the chest/abdomen/pelvis is required for study entry. See Sections 8.1.9. Body fluid will be assessed based on this study.

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 Baltimore?

Yes, this clinical trial (NCT02422641) has an active research site in Baltimore, MD 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 Baltimore, MD

If you're searching for breast cancer treatment options in Baltimore, MD, this clinical trial (NCT02422641) 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 Baltimore research site is actively enrolling participants for this phase 2 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 Baltimore, MD

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