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.
Terminated
N/A
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| PET/CT Guided FES Therapy | Experimental | 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. |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 45 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
| Measure: | Clinical Benefit Rate (CBR) |
| Time Frame: | 24 weeks |
| Safety Issue: | |
| Description: | CBR is defined as a patient having a best overall response of a complete response (CR), partial response (PR), or stable disease for at least 24 weeks. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | British Columbia Cancer Agency |
August 11, 2021
