Rayzebio IIT Study of Dotatate in Breast Cancer

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoag Memorial Hospital Presbyterian
• Collaborator: RayzeBio, Inc.

Criteria

Inclusion Criteria:

• Age of at least 18 years at the time of signing the informed consent.

• Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging.

• For women of childbearing potential (WOCBP):

a. 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:

• Known hypersensitivity to Gallium-68, octreotate, or any of the excipients of Ga-68- DOTATATE.

• 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.

• Unable to perform PET/CT scans according to technical specifications and local guidelines.

• 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.

• Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.

• Pregnancy or inability to interrupt lactation for 12 hours after Ga-68-DOTATATE administration.

• Unable or unwilling to comply with the requirements of the study protocol.

• Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.