Rayzebio IIT Study of Dotatate in Breast Cancer
Study Details
Study Description
Brief Summary
This will be a Phase 2 clinical trial to assess somatostatin receptor (SSTR) expression in Stage IV estrogen receptor positive (ER+) breast cancer using Ga-68-DOTATATE PET/CT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Subjects with metastatic breast cancer are planned to be enrolled to undergo Ga-68-DOTATATE PET/CT imaging at one time point. SSTR uptake in metastatic lesions will be evaluated by independent central review (ICR). FED PET and bone scans will also be performed within +/- 3 weeks of DOTA imaging.
The primary objective of this study is to evaluate uptake of Ga-68-DOTATE in metastatic ER+ breast cancer lesions. Additionally, the exploratory objective of this Phase 2 study is to evaluate the relationship between biomarkers and concomitant endocrine therapy with Ga-68-DOTATATE uptake.
Study Design
Outcome Measures
Primary Outcome Measures
- Uptake of Ga-68-DOTATATE using Krenning Score and standardized uptake value (SUV) [6 months]
DOTA images will be reviewed to determine anatomical site of lesions for assessment of DOTA positivity by Krenning score and by SUVmax.
Secondary Outcome Measures
- Relationship between biomarkers and concomitant endocrine therapy [6 months.]
Relationship between biomarkers (ER, PR, and HER2, SSTR2) and SSTR PET SUV
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age of at least 18 years at the time of signing the informed consent.
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Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging.
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For women of childbearing potential (WOCBP):
- Negative serum pregnancy test within 48 hours of Ga-68-DOTATATE injection. A women is considered to be of childbearing potential if she is post-menarchal, has not reached postmenopausal state (≥ 12 continuous months of amenorrhea [no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug).
- Willingness and ability to provide written informed consent prior to any study-specific assessments and procedures commence.
Exclusion Criteria:
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Known hypersensitivity to Gallium-68, octreotate, or any of the excipients of Ga-68- DOTATATE.
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Current high-dose glucocorticoid (≥ 20 mg prednisone daily or equivalent); long acting SSA within the last 28 days; short acting SSA that cannot be interrupted for 24 hours.
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Unable to perform PET/CT scans according to technical specifications and local guidelines.
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Concurrent primary malignancy other than breast cancer, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study.
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Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
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Pregnancy or inability to interrupt lactation for 12 hours after Ga-68-DOTATATE administration.
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Unable or unwilling to comply with the requirements of the study protocol.
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Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hoag Memorial Hospital Presbyterian | Irvine | California | United States | 92614 |
Sponsors and Collaborators
- Hoag Memorial Hospital Presbyterian
- RayzeBio, Inc.
Investigators
- Principal Investigator: Gary Ulaner, MD, PhD, Hoag Memorial Hospital Presbyterian
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 163-22-CA