FES-PET for Patients Treated on NCI Protocol 8762

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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) .

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate

Criteria

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