Lutetium-177 DOTATATE for Stage IV or Recurrent Breast Cancer
Official title: A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic Breast Cancer
Run by OHSU Knight Cancer Institute · NCT04529044 · Data updated 2026-11-12
This study tests whether 177Lu-DOTATATE can shrink or slow the growth of breast cancer that has spread or come back in patients whose tumors express SSTR2.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, tucatinib, chemotherapy, immunotherapy, Radiation |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | June 30, 2026 |
| Main results expected | December 20, 2027 |
| Study ends | December 20, 2027 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT04529044 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–100 with histologically confirmed metastatic breast cancer that is stage IV or recurrent, who progressed after at least two prior systemic therapies (including specific regimens per subtype) and have SSTR2-positive disease.
✕Probably not a fit
Patients whose tumors do not express SSTR2 or who experience unacceptable toxicity may not benefit from this therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial evaluates the safety and effectiveness of Lutetium-177 DOTATATE in adults with stage IV or recurrent breast cancer that shows somatostatin receptor 2 (SSTR2). Participants receive intravenous 177Lu-DOTATATE on a 4-week schedule (weeks 1, 8, 16, and 24) and undergo Ga-68 DOTATATE PET/CT imaging for staging, with ongoing imaging and blood sampling throughout. The study also includes optional biopsies and standard imaging to monitor response, followed by up to 5 years of post-treatment follow-up to assess durability of benefit and safety.
Why it matters
Potential benefit: If successful, this treatment could reduce tumor burden and circulating cancer cells in patients with SSTR2-positive breast cancer.
How similar studies have gone: Other studies using Lutetium-177 DOTATATE in receptor-positive cancers have shown signals of activity, but results in breast cancer remain investigational.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
OHSU Knight Cancer Institute
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: Rodney F Pommier — OHSU Knight Cancer Institute
- Study coordinator: Kaiya R Kozuma
- Email: kozuma@ohsu.edu
- Phone: 7024672457
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.