Is NCT07311993 recruiting in Rochester, MN?

Yes, NCT07311993 is currently recruiting participants at its Rochester, MN location. This breast cancer clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Rochester, 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 Rochester 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 Rochester, MN

About This Breast Cancer Study in Rochester

The goal of this clinical trial is to evaluate the safety and efficacy of 3 different dose levels of CLR 125 in patients with advanced triple negative breast cancer. The main questions the study aims to answer are: * What dose and regimen should be used in future trials of CLR 125 in patients with advanced triple negative breast cancer. * What side effects do participants have when taking CLR 125. Participants will: * Have CLR 125 administered via infusion 4 times each cycle; repeated every 8 weeks. * Visit the clinic once every 3 weeks for checkups and testing. * Report any side effects or new medications. Some participants may also receive one dose of CLR 131 to evaluate the amount of radiation delivered to various organs and to the tumor. These participants will: * Have 4 scans completed over 2 weeks * Have blood drawn 6 times over 2 weeks.

Sponsor: Cellectar Biosciences, Inc.

Who Can Participate

Inclusion Criteria

Unequivocal TNBC histology \[ER and PR less than 10% each and HER-2 negative\].

Patients that have progressed after at least one prior standard therapeutic regimen given alone or in combination (including, but not limited, to: chemotherapy, immunotherapy, sacituzumab govitecan-hziy, trastuzumab deruxtecan).

Patients who have received neo-adjuvant or adjuvant therapy must be at least one year from that treatment regimen.

Patient is ≥ 18 years of age.

ECOG performance status of 0 to 2.

Life expectancy ≥ 6 months.

Patient must meet the following laboratory criteria:

Platelets ≥ 75,000/uL \[75 x 10\^9/L\]

White blood cell (WBC) count ≥ 3000/uL

Absolute neutrophil count ≥ 1500/uL

Hemoglobin ≥ 9 g/dL

Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 (as reported by the local lab)

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN)

Bilirubin \< 1.5 × ULN

At least one measurable lesion, as defined by RECIST v1.1, with longest diameter at baseline ≥ 10 mm (excluding lymph nodes, for which the short diameter must be ≥ 15 mm).

Patients with known brain metastases must have completed any radiotherapy or systemic treatments for brain metastases prior to enrollment; by investigator assessment be considered stable with no new signs or symptoms for at least 1 month, and on a stable dose of steroids (unchanged for three weeks prior to registration or on a steroid tapering regimen).

Patients must express willingness and ability to comply with scheduled study visits, treatment plans, laboratory tests, and other study procedures.

Patient or their legally authorized representative must have the ability to understand and provide signed informed written consent before the initiation of any study-related procedures.

Female patients of childbearing potential must have a negative pregnancy test within 24 hours of dosing.

Women of childbearing potential must agree to use a highly effective method of contraception during the study and for 12 months following administration of the study drug. Highly effective methods of contraception include combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, vasectomized partner, or sexual abstinence. Women who have undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation, or are post-menopausal (no menses for 12 months without an alternative medical cause) are considered to be of non-childbearing potential.

Men who are able to father a child must agree to use a condom during the study and for 12 months following administration of the study drug.

Exclusion Criteria

Antitumor systemic therapy or investigational therapy, within three-half-lives of the agent preceding study drug administration. NOTE: Patients participating in non-interventional clinical trials (i.e., non-drug) are allowed to participate in this trial.

Focal radiation (including palliative radiation) to non-target lesions should be completed at least 2 weeks prior to dosing.

For patients receiving CLR 125 after participation in the dosimetry phase, CLR 131 washout is not required prior to dosing with CLR 125.

Prior targeted radiotherapy.

Prior external beam radiation therapy resulting in greater than 20% of total bone marrow receiving greater than 20 Gy. For estimation purposes, the following bone marrow percentages can be used:

Vertebral bodies: Cervical 0.5%, thoracic 1%, lumbar 2% per vertebral body

Hemipelvis (ilium, acetabulum, ischium): 13% per side

Sacrum: 10%

Scapula: 5% per side

Ribs: 4% per side

Femur: 3% per side

Ongoing Grade 2 or greater toxicities due to previous therapies, excluding alopecia, that in the opinion of investigator might be exacerbated by study treatment.

Patients with prior or concurrent malignancy other than TNBC with the following exceptions, which must be fully treated with no evidence of disease for at least 2 years: non-melanoma skin cancers only requiring topical treatment or surgical excision; melanoma in situ; treated cervical carcinoma in situ; successfully treated prostate cancer.

Any other concomitant serious illness or organ system dysfunction (including cardiac and pulmonary dysfunction) that in the opinion of the Investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.

Known history of human immunodeficiency virus or uncontrolled, serious, active infection.

Pregnancy or breast-feeding

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 Rochester?

Yes, this clinical trial (NCT07311993) has an active research site in Rochester, MN 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 Rochester, MN

If you're searching for breast cancer treatment options in Rochester, MN, this clinical trial (NCT07311993) 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 Rochester 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 Rochester, MN

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