Is NCT04529044 recruiting in Portland, OR?

Yes, NCT04529044 is currently recruiting participants at its Portland, OR location. This anatomic stage iv breast cancer ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Portland 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.

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial in Portland, OR

Q: How do I join the anatomic stage iv breast cancer ajcc v8 clinical trial in Portland?

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

About This Anatomic Stage IV Breast Cancer AJCC v8 Study in Portland

This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu. DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them. Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patient's blood for the treatment of patients with breast cancer positive for SSTR2.

Sponsor: OHSU Knight Cancer Institute

Who Can Participate

Inclusion Criteria

Life expectancy of \> 6 months, as determined by the investigator

Ability to understand and the willingness to sign a written informed consent document

Patients aged \>= 18-100 years old at time of informed consent

Histologically or cytologically confirmed metastatic breast carcinoma

Stage IV or recurrent disease with distant metastases

Female and male patients with breast cancer will be included in the study

Participants must have experienced disease progression after at least two lines of standard treatment modalities and/or one prior line of cytotoxic chemotherapy (not just endocrine therapy). Specifically, patients must have received or declined the following therapies: a) Hormone receptor positive (HR+)/HER2: endocrine therapy and CDK4/6 inhibitor (i); b) HER2+: trastuzumab, pertuzumab, T-DM1 and tucatinib; c) Triple negative breast cancer (TNBC): chemotherapy, immunotherapy (in PD-L1+ tumors). Patients can be consented if they are foregoing treatments known to confer survival advantage

Participants must have at least one measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v1).1 that is amendable to biopsy

Confirmed presence of SSTR based on \> 50% of lesions with DOTATATE uptake of 68Ga DOTATATE equivalent to the liver

Participants must have fully recovered from the acute toxic effects of all prior treatment to grade 1 or less, except alopecia and =\< grade 2 neuropathy which are allowed

Participant must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2

Participant must consent to undergo a pre-treatment screening biopsy for enrollment

Hemoglobin \>= 8.0 g/dL with no blood transfusion in the past 28 days (measured within 28 days prior to administration of study treatment)

Absolute neutrophil count (ANC) \>= 2.0 x 10\^9/L (measured within 28 days prior to administration of study treatment)

Platelet count \>= 75 x 10\^9/L (measured within 28 days prior to administration of study treatment)

Total bilirubin =\< 3 x institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment)

Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal (unless liver metastases are present in which case they must be =\< 5 x ULN) (measured within 28 days prior to administration of study treatment)

Serum albumin \>= 3.0 g/L, unless prothrombin time or international normalized ratio (INR) value is within the normal range (measured within 28 days prior to administration of study treatment)

Participants must have serum creatinine =\< 1.7 mg/dL, or creatinine clearance estimated of \>= 51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test (measured within 28 days prior to administration of study treatment)

Female participants of childbearing potential (FOCBP) must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

FOCBP agree to use a highly-effective method of contraception starting with the first dose of study therapy up to 7 months after the last dose of study therapy

FOCBP are those who are not proven postmenopausal. Postmenopausal is defined as:

Amenorrheic for \> 24 consecutive months following cessation of exogenous hormonal treatments

Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50 years of age

Radiation-induced oophorectomy with last menses \> 1 year ago

Chemotherapy-induced menopause with \> 1 year interval since last menses

Surgical sterilization (bilateral oophorectomy or hysterectomy or tubal ligation)

Exclusion Criteria

Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of first dose of 177Lu- DOTATATE treatment

Individuals in the follow-up phase of a prior investigational study may participate as long as it has been 4 weeks since last dose of the previous investigational agent or device

Prior external beam radiation therapy to more than 25% of the bone marrow

Other malignancy unless curatively treated with no evidence of disease for \>= 5 years except: adequately treated non-melanoma skin cancer or curatively treated in situ cancer of the cervix

Known brain metastases, unless these metastases have been treated and stabilized

Peptide receptor radionuclide therapy at any time prior to study enrollment

Known hypersensitivity to somatostatin analogues or any component of the 68Ga- DOTATATE or 177Lu- DOTATATE formulations

Patients with uncontrolled infection will not be enrolled until infection is treated per provider discretion

Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure

Uncontrolled diabetes mellitus as defined by a fasting blood glucose \> 2x ULN

Any patient receiving treatment with short-acting somatostatin analogs, which cannot be interrupted for both 24 hours before and after the administration of 177Lu, or any patient receiving treatment with long-acting release somatostatin analogs that cannot be interrupted for at least 4 weeks before the administration of 177Lu- DOTATATE

Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to \> 25% of bone marrow, at any time

Any chemotherapy or targeted therapy within 4 weeks prior to enrollment in the study

Current spontaneous urinary incontinence making impossible the safe administration of the radioactive study agent

Any psychiatric illness that prevents patient from informed consent process

Any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol

Participant is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment

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 Portland?

Yes, this clinical trial (NCT04529044) has an active research site in Portland, OR 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.

Anatomic Stage IV Breast Cancer AJCC v8 Treatment Options in Portland, OR

If you're searching for anatomic stage iv breast cancer ajcc v8 treatment options in Portland, OR, this clinical trial (NCT04529044) 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 Portland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anatomic stage iv breast cancer ajcc v8 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 anatomic stage iv breast cancer ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial in Portland, OR

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