PET Scans in Assessing Response To Treatment in Patients Receiving Hormone Therapy or Trastuzumab for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Early Assessment of Response to Targeted Breast Cancer Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362973
• Other study ID #: 6213
• Secondary ID: P30CA015704UWCC-
• Status: Completed
• Phase: N/A
• First received: August 10, 2006
• Last updated: December 23, 2016
• Start date: May 2006

Study information

• Verified date: May 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as PET scans, may help in learning how well hormone therapy and trastuzumab work to kill breast cancer cells and allow doctors to plan better treatment.

PURPOSE: This clinical trial is studying how well PET scans work in assessing response to treatment in patients receiving hormone therapy or trastuzumab for breast cancer.

Description:

OBJECTIVES:

• Correlate the percent change in fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) standardized uptake value (SUV) and percent change in cell proliferation (as assessed by tumor biopsy) during hormonal therapy with tumor response in patients with hormone receptor-positive (estrogen receptor or progesterone receptor) breast cancer.

• Correlate the percent change in FDG-PET SUV and percent change in cell proliferation (as assessed by tumor biopsy) during treatment with trastuzumab (Herceptin®) with tumor response in patients with HER-2/neu-positive breast cancer.

• Compare the association between two-week changes in cell proliferation rate (as measured by FDG-PET and biopsy) in patients treated with an aromatase inhibitor or trastuzumab.

OUTLINE: Patients are assigned to 1 of 2 groups according to therapy.

• Group 1 (patients receiving hormonal therapy): Patients undergo fludeoxyglucose F 18-positron emission tomography (FDG-PET) scan and may also undergo 16α-fluoroestradiol F 18 (FES)-PET scan at baseline (prior to beginning therapy) and FDG-PET scan 2 weeks after beginning therapy.

Blood samples are collected at baseline and at 3 and 6 months after beginning aromatase inhibitor therapy. The blood samples are examined for hormone levels, including estradiol, estrone, testosterone, follicle-stimulating hormone, and sex hormone-binding globulin.

• Group 2 (patients receiving HER-2/neu targeted therapy): Patients undergo biopsy and FDG-PET scan at baseline (prior to beginning therapy) and FDG-PET scan 1-2 weeks after beginning therapy.

Some patients undergo a core-needle biopsy 2 weeks after beginning therapy. Biopsies are assessed for the following markers: proliferative rate (Ki67), estrogen receptor, progesterone receptor, HER-2/neu, epidermal growth factor receptor, androgen receptor, and topoisomerase II.

After completion of study therapy, patients are followed periodically for 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Newly diagnosed breast cancer with 1 of the following:

• Hormone receptor-positive disease and planning to receive treatment with neoadjuvant aromatase inhibitor and ovarian suppression therapy (if premenopausal)

• Recurrent and/or metastatic hormone receptor-positive disease and planning to receive treatment with an aromatase inhibitor and ovarian suppression therapy (if premenopausal)

• Metastatic HER-2/neu-positive disease and planning to receive treatment with neoadjuvant trastuzumab (Herceptin®)

• Recurrent HER-2/neu-positive disease and planning to receive treatment with trastuzumab (Herceptin®)

• Tumor must be accessible for biopsy and assessable for response

• Tissue block must be available for review of experimental markers or patient must be willing to undergo biopsy

• Evaluable disease by FDG-PET scan

• Available for positron emission tomography (PET) imaging with a clinical indication for PET scan

• May aslo be enrolled on an experimental nuclear imaging study of 16a-fluoroestradiol F 18-PET scan (if hormone positive)

• Concurrently receiving treatment (hormonal or other) for breast cancer

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

• Female or male

• Postmenopausal or premenopausal

• Life expectancy = 2 months

• No uncontrolled diabetes mellitus or other comorbidity that would preclude imaging

• Not pregnant

• Negative pregnancy test

• Able to tolerate scanning (e.g., no claustrophobia or severe pain)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Concurrent participation on another clinical study or other imaging studies allowed

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• laboratory biomarker analysis

Procedure:
• needle biopsy

• positron emission tomography

• radionuclide imaging

Radiation:
• fludeoxyglucose F 18

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in fludeoxyglucose F 18-positron emission tomography (FDG-PET) standardized uptake value and change in markers of proliferation (Ki67) at 2 weeks		2 weeks	No
Primary	Percent change in cell proliferation correlated with absolute measures of FDG-PET		2 weeks	No
Primary	Correlation of early FDG-PET with response prediction		6 months	No