PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer

British Columbia Cancer Agency

Status: Terminated

Conditions: Breast Cancer

Treatments: Procedure: Diagnostic Imaging: 18F-FES PET/CT - Baseline; Procedure: Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up; Procedure: Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline

Study type: Interventional

Funder types: Other

Identifiers

NCT00816582

PET/CT Breast

Details and patient eligibility

About

Purpose:

To determine whether [18F]FES can predict clinical benefit (defined as complete response, partial response and stable disease ≥ 6 months) to fulvestrant (250 mg IM q 28 days) in post-menopausal women with recurrent or metastatic ER+ breast cancer who are candidates for further hormonal therapy.

Full description

The majority of women diagnosed with breast cancer are post-menopausal, of which up to 75% are estrogen (ER) and/or progesterone receptor (PR) positive. Even in pre-menopausal breast cancer over half of all patients will have expression of these hormone receptors. Thus therapeutic strategies targeting the estrogen receptor or its ligand are the most common treatment offered in breast cancer. Despite substantial benefits now demonstrated with selective estrogen receptor modulators (e.g. tamoxifen) and aromatase inhibitors (e.g. anastrazole, letrozole and exemestane), a significant proportion of patients will still unfortunately have or develop resistance to these hormonal therapies.

Despite approximately two-thirds of patients who are prescribed fulvestrant following prior hormonal agents not benefiting from this therapy, clinicians are still offering this option to all suitable women because of the lack of a better means of identifying the individual responders.

To assess whether the recommended treatment is beneficial to a specific individual, the disease burden is assessed before and following treatment. Conventional imaging techniques such as the bone scan or computerized tomography (CT) can take several months to show a successful response to treatment. Positron emission tomography (PET) can improve the evaluation of women with breast cancer by providing an accurate assessment of the extent of disease and unique information about tumor biology such as metabolic activity.

Enrollment: 17 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for > 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy)
• hormone receptor positive (ER and/or PgR) disease as determined locally
• WHO performance status 0-2
• life expectancy of ≥ 3 months
• the presence of at least one measurable or evaluable (non-measurable) lesion
• informed consent prior to any study procedures

Exclusion criteria

• life threatening metastatic visceral disease
• brain or leptomeningeal metastases
• prior exposure to fulvestrant
• history of bleeding diathesis or need for long term anti-coagulation

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

PET/CT Guided FES Therapy

Experimental group

Description:

All subjects will be seen at baseline and then monthly until month 6 of fulvestrant therapy unless clinical or radiological progression or unacceptable toxicity earlier than month 6.

Treatment:

Procedure: Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up

Procedure: Diagnostic Imaging: 18F-FES PET/CT - Baseline

Procedure: Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline