FES-PET for Patients Treated on NCI Protocol 8762

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Farrokh Dehdashti, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01714128
First received: October 17, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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) .


Condition Intervention
Breast Cancer
Drug: Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • FES baseline tumor SUV measurement [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Optional Diagnostic Imaging
Optional diagnostic imaging FES-PET/CT imaging
Drug: Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))
FES-PET/CT imaging

Detailed Description:

Approximately 75% of all invasive breast cancers are hormone sensitive [estrogen-receptor positive (ER+) or progesterone-receptor positive (PR+)] and patients with such cancers are candidates for endocrine therapy. Endocrine therapy is a central component of the treatment of hormone-sensitive breast cancer in the adjuvant and, increasingly, neoadjuvant settings. Knowledge of hormone receptor expression is essential for selection of appropriate therapy. Measurement of hormone-receptor expression [estrogen receptor (ER) or progesterone receptor (PR)] using in vitro assays of the tumor tissue at the time of primary diagnosis is standard of clinical care. However, the presence of these hormone receptors predicts for clinical benefit in only 30-50% of women with advanced disease receiving first-line endocrine therapy and 15-30% receiving second-line therapy (1-3). Thus, the presence of a hormone receptor does not indicate that the receptor is functional and essential to the growth of the cancer cell, nor does it imply that interference with receptor function will result in tumor cell kill. There are several shortcomings of the in vitro assays and neither quantitative nor qualitative receptor assays performed on samples of tumor tissue completely predict the response to antiestrogen therapy in breast cancers. In addition, none of the current clinical tools (serologies, prognostic factors, or radiologic studies) can accurately predict for clinical benefit from endocrine therapy. Accordingly, better methods for predicting clinical response to antiestrogen therapy need to be developed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714128

Locations
United States, Missouri
Mallinckrodt Institute of Radiology
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Farrokh Dehdashti, M.D. Washington Univesity in St. Louis
  More Information

No publications provided

Responsible Party: Farrokh Dehdashti, Professor of Radiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01714128     History of Changes
Other Study ID Numbers: Dehdashti FES NCI#9167
Study First Received: October 17, 2012
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
NCI protocol #8762
Estrogen receptor positive breast cancer
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estradiol
Aromatase Inhibitors
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014