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SCCA Breast Cancer Clinical Trials

Early Assessment Challenge Grant (7043)
Imaging Early Response of ER+, HER2- Breast Cancer To Aromatase Inhibitor (AI) Therapy
Status Conditions Phase Study ID
Recruiting Breast Cancer N/A 7043
Summary

The purpose of this study is to measure the effect of a short course of endocrine therapy on primary breast cancer metabolism and proliferation by measuring changes in serial PET pre and post a 1 - 3 week course of endocrine therapy before breast cancer surgery.

This study involves positron emission tomography (PET) imaging and pathologic assessments. Positron emission tomography (PET) is a type of radiologic scan that uses a large donut shaped detection device to pick up tiny radiation signals given off by a radioactive tracer. In this study the radiotracer, [F-18] fluorodeoxyglucose (FDG) is used which allows us to see how tumors metabolize glucose, a sugar.

The study will take place within the short window of time prior to surgery, which can be up to six weeks. All patients will undergo a baseline research FDG PET scan at either the Seattle Cancer Care Alliance (SCCA) or the University of Washington Medical Center (UWMC). After the baseline scan the patient will start the AI treatment as prescribed by their medical oncologist for the remaining time (can be 1-3 weeks) prior to their surgery. The goal is to have the patient undergo a repeat research FDG PET scan at the same institution where the baseline was performed 1-3 days before surgical resection. The patient will proceed to the clinically planned surgery, which will conclude participation in the research study.


Investigator
David Mankoff, M.D., PhD Hannah Linden, M.D.
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)

DISEASE CHARACTERISTICS:
Inclusion criteria

  • New diagnosis of primary invasive breast cancer with the below features:
    • Clinical Stage I-II
    • Size greater than 1.0 cm and less than 5 cm
    • Estrogen receptor (ER) positive for tumor expression
    • HER2/neu receptor negative for tumor expression (If intermediate by IHC, FISH must be performed)
  • Biopsy with adequate tissue available

PATIENT CHARACTERISTICS:
Inclusion criteria

  • Be postmenopausal For study purposes, postmenopausal is defined as:
    • A prior documented bilateral oophorectomy, or
    • A history of at least 12 months without spontaneous menstrual bleeding, or
    • Age 60 or older with a prior hysterectomy without oophorectomy, or
    • Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab.
  • Planned surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs)
Exclusions (conditions that would prevent participation in this study)

DISEASE CHARACTERISTICS:
Exclusion criteria

  • HER2/neu tumor expression positive by IHC and/or FISH
  • No evaluable disease by a FDG PET scan

PATIENT CHARACTERISTICS:
Exclusion criteria

  • Uncontrolled diabetes mellitus
  • Comorbidities that preclude imaging
  • Life expectancy of less than two months
  • Inability to tolerate scanning (e.g. - claustrophobia, severe pain)
Last Updated
March 24, 2011
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.