177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer

NCT04529044 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00019489NCI-2020-04795
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Recurrent Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  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).

  Up to 3 months post-therapy

Secondary Outcomes (5)

• Disease control rate (DCR)

  Up to 3 months post-therapy

• Duration of response (DOR)

  Up to 12 months post-therapy

• Progression-free survival

  Up to 12 months post-therapy

• Incidence of adverse events (AEs)

  Up to 3 months post-therapy

• Duration of stable disease

  Up to 12 months post-therapy

Study Arms (1)

Treatment (177Lu-DOTATATE)

EXPERIMENTAL

Patients receive 177Lu-DOTATATE IV over 30-40 minutes during weeks 1, 8, 16, and 24 in the absence of disease progression or unacceptable toxicity. Patients also receive Ga 68-DOTATATE and undergo PET/CT during screening, biopsy as clinically-indicated as well as CT and/or MRI and collection of blood samples throughout the study.

Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Gallium Ga 68-DOTATATE; Drug: Lutetium Lu 177 Dotatate; Procedure: Positron Emission Tomography

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (177Lu-DOTATATE)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (177Lu-DOTATATE)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (177Lu-DOTATATE)

Gallium Ga 68-DOTATATE RADIATION

Receive 68Ga

Also known as: (68)Ga-DOTA-TATE, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 Oxodotreotide, Gallium Oxodotreotide Ga-68, Gallium-68 DOTA-DPhe1, Tyr3-octreotate

Treatment (177Lu-DOTATATE)

Lutetium Lu 177 Dotatate DRUG

Given IV

Also known as: 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, Lutathera, Lutetium Lu 177 DOTA(0)-Tyr(3)-Octreotate, Lutetium Lu 177-DOTA-Tyr3-Octreotate, lutetium Lu 177-DOTATATE, Lutetium Oxodotreotide Lu-177

Treatment (177Lu-DOTATATE)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (177Lu-DOTATATE)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Advanced Accelerator Applications: collaborator
• Oregon Health and Science University: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy; Specimen Handling; Ga(III)-DOTATOC; gallium Ga 68 dotatate; lutetium Lu 177 dotatate; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Rodney F Pommier

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaiya R Kozuma

CONTACT

7024672457; kozuma@ohsu.edu

Rodney F Pommier

CONTACT

5034945501; pommierr@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)