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Study to Determine the Utility of FES-PET and FDG-PET in the Prediction of Response to Hormone Therapy in Women With Estrogen Positive Metastatic Breast Cancer

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: NCT00358098
Recruitment Status : Terminated
First Posted : July 28, 2006
Last Update Posted : September 30, 2014
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:

This study of hormone positive (estrogen receptor [ER]), metastatic invasive ductal breast cancer looks at functional scanning using positron emission tomography (PET) and patient response to hormone therapy. Functional scans allow investigators to see more than one metastatic location. The investigators will use an estrogen based agent (FES) to see the number of hormone positive metastases and compare that to positive lesions on routine glucose (FDG) based scanning.

FES and FDG-PET results will be compared to give a FDG to FES ratio. The PET ratio will be calculated before hormone therapy and at relapse after treatment. The investigators will biopsy an accessible lesion that is FDG positive and FES negative and perform pathological testing for ER and PR positivity and compare it to the original primary tumor ER/PR. The investigators will test the lesion for tumor proliferation (using Ki-67) and aggressiveness using human epidermal growth factor receptor 2 (HER-2). Results will be compared to the primary tumor Ki-67 and HER-2 to determine concordance.

The investigators will have pre-treatment results for FES and FDG-PET, will calculate the ratio, and will correlate it to the primary metastatic lesion and test for ER/PR, Ki-67, and HER-2, and subsequent response to therapy. The investigators will determine the FES-PET predictive value for determining appropriateness of hormone therapy for metastatic disease. With these results, the investigators plan to undertake future tumor biomarker/PET studies in metastatic breast cancer.

Condition or disease
Metastatic Breast Cancer

Detailed Description:

Primary objective: To determine the utility of pre-treatment (16 alpha[18-F]-fluoroestradiol) FES-PET and routine ([18-F]-fluorodeoxy-D-glucose) FDG-PET in the prediction of response to hormone therapy using standard response criteria (RECIST) as gold standard in 100 primary tumor hormone positive (ER+) women with metastatic carcinoma of the breast.

We will measure standardized uptake ratio (SUV) for FDG and FES at baseline and correlate same to FDG/FES SUV ratio at disease relapse. We predict increased FDG/FES ratio at relapse and using the Pearson correlation coefficient will examine the regression equation slope as a measure of the changing ratio.

Twenty - forty patients will have core biopsy of accessible FDG positive and FES negative metastasis. Metastatic lesion immunohistochemistry (IHC) for ER will be compared to pretherapy FES result for concordance. With 80% agreement level for negative FES and negative core biopsy ER IHC 95% confidence limits (DI) are 56-94% for 20 and 64-90% for 40 patients respectively.

Proliferative index and tumor aggressiveness using IHC for Ki-67 and HER-2 respectively will be measured on primary tumor and biopsied metastatic lesion and correlated with metastatic disease response (RECIST).

Secondary objectives regarding HER-2 and Ki-67 IHC and response will be evaluated using Fisher's exact test for 2 X 2 tables for the 100 women and the 20-40 having core biopsy.

From the sensitivity and specificity determinations, calculated observed agreement between pretherapy FDG FES-PET ratio and RECIST will be 86% (95% CI 78-92%).

Assuming 40% response rate for 100 women receiving first, second or third line hormonal therapy and RECIST response as gold standard, we chose 80% sensitivity (95% CI 64-91%) and 90% specificity (95% CI 80-96%) as giving sufficiently robust data to warrant further studies.

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Study Type : Observational
Actual Enrollment : 51 participants
Time Perspective: Prospective
Official Title: For Women With Estrogen Positive Metastatic Breast Cancer Discordance of Pre-treatment FDG-PET and FES-PET in Addition to Presence of Ki-67 and Human Epidermal Growth Factor 2 (HER-2) Overexpression Will Predict for Hormone Refractory Disease When Compared to Standard Response Criteria
Study Start Date : August 2006
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic

Inclusion Criteria:

  • Metastatic invasive ductal ER positive breast cancer
  • All adjuvant treatment must have been completed at least 3 months prior to study entry.

Exclusion Criteria:

  • Patients who do not have the primary tumor subtype of invasive ductal adenocarcinoma
  • Patients with only loco-regional recurrence

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): NCT00358098

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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
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Principal Investigator: K. Tonkin, MD AHS Cancer Control Alberta
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Responsible Party: AHS Cancer Control Alberta Identifier: NCT00358098    
Other Study ID Numbers: BR-1-0093
First Posted: July 28, 2006    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Keywords provided by AHS Cancer Control Alberta:
hormone positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases