Actively Recruiting
A Phase II Pilot Study of Lutetium (177Lu)-DOTATATE Treatment in Patients With Metastatic or Recurrent Breast Cancer
Led by OHSU Knight Cancer Institute · Updated on 2026-06-05
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
A
Advanced Accelerator Applications
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well 177Lu-DOTATATE works to treat patients with stage IV or recurrent breast cancer that shows evidence of a protein called SSTR2. This phase II study explores whether this targeted therapy can shrink or destroy tumors and circulating cancer stem cells in the blood. 177Lu-DOTATATE combines a radioactive agent with DOTATATE, which attaches to tumor cells with SSTR2 to deliver targeted treatment. Participants receive 177Lu-DOTATATE intravenously over 30 to 40 minutes during weeks 1, 8, 16, and 24 if their disease does not progress and they do not experience unacceptable side effects. Before treatment, patients undergo imaging with gallium 68-DOTATATE PET/CT scans and biopsies as needed. Throughout the study, patients have CT or MRI scans and blood samples collected to monitor disease and treatment effects. After completing the treatment phase, participants are followed every 3 months for up to 5 years. The research team measures tumor response, disease control, duration of treatment effect, progression-free survival, and treatment safety. Blood tests, imaging, and biopsies help track how well the therapy works and any side effects, supporting long-term monitoring of patient health.
CONDITIONS
Brief Title
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy of more than 6 months as determined by the investigator
- Ability and willingness to sign informed consent
- Age between 18 and 100 years at consent
- Histologically or cytologically confirmed metastatic breast carcinoma
- Stage IV or recurrent breast cancer with distant metastases
- Both female and male patients with breast cancer
- Disease progression after at least two standard treatments or one prior chemotherapy
- At least one measurable disease site suitable for biopsy
- Confirmed presence of SSTR with over 50% of lesions showing DOTATATE uptake
- Recovery from prior treatment side effects to grade 1 or less, except alopecia and grade 2 neuropathy allowed
- ECOG performance status of 2 or less
- Consent to pre-treatment screening biopsy
- Hemoglobin ≥ 8.0 g/dL without recent transfusion
- Absolute neutrophil count ≥ 2.0 x 10^9/L
- Platelet count ≥ 75 x 10^9/L
- Total bilirubin ≤ 3 times institutional upper limit
- AST/ALT ≤ 2.5 times upper limit unless liver metastases are present (then ≤ 5 times)
- Serum albumin ≥ 3.0 g/L or normal coagulation parameters
- Serum creatinine ≤ 1.7 mg/dL or creatinine clearance ≥ 51 mL/min
- Female participants of childbearing potential must have negative pregnancy test and agree to contraception starting with first dose until 7 months after last dose
- Specific definitions for postmenopausal status and surgical sterilization apply
You will not qualify if you...
- Participation in another investigational study or receipt of investigational therapy within 4 weeks before first dose
- Prior external beam radiation to more than 25% of bone marrow
- Other malignancy unless cured with no disease for 5 years, except certain skin and cervical cancers
- Known brain metastases unless treated and stable
- Prior peptide receptor radionuclide therapy
- Hypersensitivity to somatostatin analogues or components of study drugs
- Uncontrolled infection
- Uncontrolled illnesses including serious heart conditions or recent myocardial infarction
- Uncontrolled diabetes with fasting glucose over twice the normal limit
- Use of somatostatin analogs that cannot be interrupted around treatment
- Recent surgery, radiofrequency ablation, radioembolization, chemoembolization, or radiation affecting over 25% bone marrow
- Chemotherapy or targeted therapy within 4 weeks prior to enrollment
- Spontaneous urinary incontinence preventing safe radioactive agent administration
- Psychiatric illness preventing informed consent
- Any condition endangering safety or protocol compliance
- Pregnancy, breastfeeding, or planning to conceive during trial and 6 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 weeks
Participants receive 177Lu-DOTATATE intravenously over 30-40 minutes during weeks 1, 8, 16, and 24 if their disease does not progress and they tolerate the therapy. Biopsies, PET/CT scans, CT and/or MRI scans, and blood sample collections occur as part of the treatment period.
4 infusion visits at weeks 1, 8, 16, and 24 with additional imaging and blood sample collections throughout
Duration - Up to 5 years
After completing treatment, participants are followed every 3 months for up to 5 years to monitor their health and disease status.
Quarterly visits every 3 months
Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
K
Kaiya R Kozuma
R
Rodney F Pommier
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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