Breast Cancer Clinical Trial
Official title:
Positron Emission Tomography (PET) With 18F-Fluoroestradiol (FES) as a Predictor of Response in Patients With Breast Cancer Scheduled to be Treated With MK-2206 in Combination With Either an Aromatase Inhibitor or Fulvestrant on NCI Protocol 8762
Verified date | October 2021 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A significant number of all invasive breast cancers are hormone sensitive and may be candidates for treatment with hormonal therapy. This project will assess the ability and usefulness of imaging hormone-receptor status in breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES), an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients must have agreed and signed consent to participate in NCI protocol 8762 and be scheduled to receive the first dose of MK-2206 in a minimum of 48 hours and a maximum of 30 days after the FES-PET/CT imaging. Note: Patients need to be on the endocrine agent for at least 1 week prior to the FES-PET/CT imaging. 2. Patients must have measurable disease (defined by RECIST criteria) or the presence of bone lesions if there is no measurable lesion. 3. Patient must be = 18 years of age. 4. Patient must be able to tolerate and have no contraindication to FES-PET/CT imaging. 5. Patient must be able and willing to give informed consent. Exclusion Criteria: 1. Patient must have no other active cancer at the time of study entry. 2. The research FES-PET/CT scan could not be scheduled more than 48 hours before starting therapy with MK-2206. 3. Patient cannot have received treatment for any other malignancy, with the exception of non-melanoma skin cancer, in the past 5 years. 4. Patients scheduled to receive chemotherapy as the primary source of treatment |
Country | Name | City | State |
---|---|---|---|
United States | Mallinckrodt Institute of Radiology | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FES baseline tumor SUV measurement | Up to 36 months |
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