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Trial record 47 of 50 for:    MK-2206

FES-PET for Patients Treated on NCI Protocol 8762

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01714128
Recruitment Status : Withdrawn
First Posted : October 25, 2012
Last Update Posted : February 6, 2014
Information provided by (Responsible Party):
Farrokh Dehdashti, Washington University School of Medicine

Brief 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) .

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES)) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Optional Diagnostic Imaging
Optional diagnostic imaging FES-PET/CT imaging
Drug: Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))
FES-PET/CT imaging

Primary Outcome Measures :
  1. FES baseline tumor SUV measurement [ Time Frame: Up to 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01714128

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

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Responsible Party: Farrokh Dehdashti, Professor of Radiology, Washington University School of Medicine Identifier: NCT01714128     History of Changes
Other Study ID Numbers: Dehdashti FES NCI#9167
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014
Keywords provided by Farrokh Dehdashti, Washington University School of Medicine:
NCI protocol #8762
Estrogen receptor positive breast cancer
recurrent breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female