177Lu-DOTATATE for Stage IV or Recurrent Breast Cancer
This study is looking at how well a treatment called 177Lu-DOTATATE works for people with stage IV or recurrent (has come back) breast cancer. 177Lu-DOTATATE is a targeted therapy that uses a radioactive agent (177Lu) attached to a molecule (DOTATATE). DOTATATE finds and attaches to specific proteins (SSTR2) on cancer cells, delivering the 177Lu to kill them. The study aims to see if 177Lu-DOTATATE can shrink or destroy tumors. To join, you must be 18 to 100 years old, have stage IV or recurrent breast cancer, and a life expectancy of more than 6 months. The main goal is to see how many patients respond to the treatment, measured up to 3 months after therapy. The study is currently unclear on its recruitment status and plans to enroll 10 participants.
- Study design
- This is an interventional study, but the phase is not specified. It plans to enroll 10 participants.
- What's involved
- You would receive 177Lu-DOTATATE intravenously (IV) over 30-40 minutes during weeks 1, 8, 16, and 24. You would also have PET/CT scans, blood draws, and potentially a biopsy.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would be followed up every 3 months for up to 5 years.
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NCT04529044
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentOHSU Knight Cancer InstituteInvestigator-initiated
~10 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyGallium Ga 68-DOTATATELutetium Lu 177 DotatatePositron Emission Tomography
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over Up to 3 months post-therapy
Conditions
Where it's being run
1 sites across 1 statesOregon1
Study leadership
- Rodney F Pommier · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Objective response rate (ORR)Up to 3 months post-therapy
Using the intent to treat (ITT) set and the efficacy analysis set, each ORR will be reported as a point estimate along with a 2-sided 95% exact confidence interval (CI).