Clinical trial NCT05880394: Study of Dotatate Imaging in Breast Cancer
Official title: Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Stage IV
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT.

Detailed description: Subjects with metastatic breast cancer are planned to be enrolled to undergo Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT imaging at one time point. SSTR uptake in metastatic lesions will be evaluated by independent central review (ICR). FDG PET and bone scans will also be performed within +/- 3 weeks of DOTATATE imaging.

The primary objective of this study is to evaluate uptake of Gallium-68 DOTATATE or Copper-64 DOTATATE in metastatic ER+ breast cancer lesions.

Eligibility 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 DOTATATE or Copper-64 DOTATATE, octreotate, or any of the excipients of Gallium-68 DOTATATE or Copper-64 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, 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.
* 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.

Primary outcomes:
measure: Uptake of Ga-68-DOTATATE or Copper-64 DOTATATE using Krenning Score and standardized uptake value (SUV)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
Study officials:
affiliation: Hoag Memorial Hospital Presbyterian
name: Gary Ulaner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: