Clinical Trials /

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

NCT00816582

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
  • Official Title: A Phase II Clinical Trial to Evaluate 18F-Fluoroestradiol Positron Emission Tomography / Computerized Tomography (PET/CT) Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: PET/CT Breast
  • NCT ID: NCT00816582

Conditions

  • Breast Cancer

Purpose

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.

Detailed 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.
    

Trial Arms

NameTypeDescriptionInterventions
PET/CT Guided FES TherapyExperimentalAll 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.

    Eligibility Criteria

            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

    Primary Outcome Measures

    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.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:British Columbia Cancer Agency

    Trial Keywords

    • Post-menopausal hormone receptor positive recurrent/metastatic breast cancer.
    • PET/CT
    • Recurrent or metastatic

    Last Updated

    March 4, 2016