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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00358098
• Other study ID #: BR-1-0093
• Status: Terminated
• Start date: August 2006
• Est. completion date: June 2013

Study information

• Verified date: June 2024
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada,