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FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer

Complete title: Imaging Early Response of ER+, HER2- Breast Cancer To Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy with [18F]fluorothymidine (FLT) PET

Research Study Number       7536
Principal Investigator       Hannah Linden, MD
Phase       NA

Look up trial at NIH

Research Study Description

This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III

- Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study

- Have tissue block available from core biopsy for correlative biomarkers and genomic assay

- Have menopausal status determined prior to study enrollment; 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 follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab

- Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients

- Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed

- Be a candidate for [18F]FLT PET imaging

- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures

- Be willing and able to comply with scheduled visits and other trial procedures

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Current use of aromatase inhibitor as prevention or treatment for breast cancer

- Life expectancy of less than two months

- HER2/neu positive by IHC and/or another FDA approved HER2 testing method

- Inability to tolerate scanning (e.g. - claustrophobia, severe pain)

- Weight exceeding capacity of imaging table

Other exclusion criteria may apply.

Research Study Number       7536
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Breast Cancer; Solid Tumors

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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.

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