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Anatomic Stage IV Breast Cancer AJCC v8Phase 2NCT04529044

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

A Phase 2 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Biopsy, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
30 Jun 2026to 20 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kaiya R Kozuma contact

7024672457

kozuma@ohsu.edu

Rodney F Pommier contact

5034945501

pommierr@ohsu.edu

United States1 site, 1 recruiting

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Rodney Pommier, (503) 494-5501, pommierr@ohsu.edu

    Rodney Pommier

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic Breast Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Assess objective response in study participants receiving lutetium Lu 177 dotatate (177Lu-DOTATATE) therapy.

SECONDARY OBJECTIVES:

  1. Assess the rate of disease control following 177Lu-DOTATATE therapy. II. Evaluate duration of treatment response to 177Lu-DOTATATE. III. Assess progression-free survival (PFS). IV. Assess safety and tolerability of the 177Lu-DOTATATE therapy. V. Evaluate over time the requirements for stable disease.

OUTLINE:

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

After completion of study treatment, patients are followed up every 3 months for up to 5 years.

Being tested
Biopsy, Biospecimen Collection, Computed Tomography, Gallium Ga 68-DOTATATE, Lutetium Lu 177 Dotatate
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Gallium Ga 68-DOTATATERadiation

    Also called (68)Ga-DOTA-TATE, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 Oxodotreotide

    Receive 68Ga

  • Lutetium Lu 177 DotatateDrug

    Also called 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, Lutathera

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

Study groups in NCT04529044
Study groupRoleWhat they receive
Treatment (177Lu-DOTATATE)ExperimentalPatients 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.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Gallium Ga 68-DOTATATE; Drug: Lutetium Lu 177 Dotatate; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 3 months post-therapy

Secondary outcomes (5)

  1. Disease control rate (DCR)

    A point estimate and 2-sided 95% CI will be provided for the DCR, defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD) (as assessed by the investigator per Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1).

    Measured: Up to 3 months post-therapy

  2. Duration of response (DOR)

    DOR will be estimated on responding participants and plotted with cumulative incidence functions: one curve for the first occurrence of recurrence, progression, or disease-related death and one curve for deaths in the absence of disease recurrence or progression.

    Measured: Up to 12 months post-therapy

  3. Progression-free survival

    PFS will be plotted using a Kaplan-Meier curve and reported with median survival and a 95% CI.

    Measured: Up to 12 months post-therapy

  4. Incidence of adverse events (AEs)

    The severity of the AE will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Study drug-related AEs are those assessed by investigator as definitely or probably related. Using the safety analysis set, the incidence of treatment emergent adverse events (TEAEs) and non-treatment-related AEs will be determined for study participants who receive at least one dose of lutetium Lu 177 dotatate (177Lu- DOTATATE). The point estimate and 95% CI will be reported for overall toxicities as well as for each major organ category.

    Measured: Up to 3 months post-therapy

  5. Duration of stable disease

    Measured: Up to 12 months post-therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion20 Dec 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04529044
Sponsor's protocol ID
STUDY00019489
Other IDs
NCI-2020-04795, STUDY00019489
Status last verified
Jun 2026
First submitted
24 Aug 2020
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individuals will be pooled

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kaiya R Kozuma (7024672457, kozuma@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to 3 months post-therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04529044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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