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

This study is currently recruiting participants.
Verified March 2016 by British Columbia Cancer Agency
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816582
First Posted: January 1, 2009
Last Update Posted: March 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
British Columbia Cancer Agency
  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.


Condition Intervention Phase
Breast Cancer Procedure: Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline Procedure: Diagnostic Imaging: 18F-FES PET/CT - Baseline Procedure: Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Clinical Benefit Rate (CBR) [ Time Frame: 24 weeks ]
    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.


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET/CT Guided FES Therapy
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.
Procedure: Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline
A18F-FDG PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to identify the sites involved by the subject's cancer.
Procedure: Diagnostic Imaging: 18F-FES PET/CT - Baseline
A 18F-FES PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to determine the hormone receptor content of the sites involved by the breast cancer.
Procedure: Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up
A 18F-FES PET/CT scan performed after three (3) monthly injections of fulvestrant to determine whether estrogen uptake is blocked by fulvestrant.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816582


Contacts
Contact: Stephen Chia, MD 604-877-6000 ext 2752 schia@bccancer.bc.ca
Contact: Francois Benard, MD 604-877-6000 ext 5979 fbenard@bccancer.bc.ca

Locations
Canada, British Columbia
BC Cancer Agency - Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Susan Ellard, MD    250-712-3996    sellard@bccancer.bc.ca   
Principal Investigator: Susan Ellard, MD         
Sub-Investigator: Marianne Taylor, MD         
Sub-Investigator: Barbara Czerkawski, MD         
BC Cancer Agency - Fraser Valley Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Gary Pansegrau, MD    604-930-4017    gpansegrau@bccancer.bc.ca   
Principal Investigator: Gary Pansegrau, MD         
Sub-Investigator: Abdulwahab Al-Tourah, MD         
Sub-Investigator: Ravinder Sawhney, MD         
BC Cancer Agency - Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Stephen Chia, MD    604-877-6000 ext 2752    schia@bccancer.bc.ca   
Contact: Francois Benard, MD    604-877-6000 ext 5979    fbenard@bccancer.bc.ca   
Principal Investigator: Stephen Chia, MD         
Sub-Investigator: Caroline Lohrisch, MD         
Sub-Investigator: Cheryl Ho, MD         
Sub-Investigator: Karen Gelmon, MD         
Sub-Investigator: Don Wilson, MD         
BC Cancer Agency - Vancouver Island Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Nicol Macpherson, MD    250-519-5572    nmacpherson@bccancer.bc.ca   
Sub-Investigator: Vanessa Bernstein, MD         
Principal Investigator: Nicol Macpherson, MD         
Sub-Investigator: Sheila Souliere, MD         
Sub-Investigator: Andrew Attwell, MD         
Sub-Investigator: Sharon Allan, MD         
Sub-Investigator: Jason Hart, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Stephen Chia, MD BC Cancer Agency - Vancouver Centre
  More Information

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00816582     History of Changes
Other Study ID Numbers: PET/CT Breast
First Submitted: December 30, 2008
First Posted: January 1, 2009
Last Update Posted: March 7, 2016
Last Verified: March 2016

Keywords provided by British Columbia Cancer Agency:
Post-menopausal hormone receptor positive recurrent/metastatic breast cancer.
PET/CT
Recurrent or metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Fluorodeoxyglucose F18
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action