Imaging of ER Density to Guide and Improve Tailored Therapy for Acquired Anti-hormonal Resistant Breast Cancer

NCT01088477 | Completed

• 1 other identifier: RUG 2009-4529
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

In 50 breast cancer patients, heavily pretreated with anti-hormonal therapy, the investigators will evaluate the use of 16-alpha\[18-fluoro\]-17beta-estradiol positron emission tomography (FES-PET)as predictive biomarker for response to estrogen therapy.

Conditions

Breast Cancer

Keywords

Acquired anti-hormonal resistant breast cancer

Outcome Measures

Primary Outcomes (1)

• Quantifying FES-uptake to predict response to estrogen therapy

  FES-uptake (prior to estrogen therapy) of tumour lesions will be recorded for all patients. Patients will be prospectively categorized into responders and non-responders during standard follow-up (consisting of monthly visits, 3-monthly CT, and other techniques when indicated). Patients with complete response, partial response or stable disease for \>6 months are defined as 'responders'. With ROC analysis we will determine the optimal cut-off value for FES-uptake to predict response to estrogen therapy.

  2 years

Study Arms (1)

Breast cancer patients with acquired anti-hormonal resistance

Other: Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol

Interventions

Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol OTHER

In patients with acquired antihormonal resistance, eligible for estrogen therapy, a FES-PET scan will be made to determine FES-PET tumor uptake (which corresponds to estrogen receptor expression levels). Immediately after the FES-PET scan, all patients will start with a standard accepted dose of 2mg estradiol TID. Therapy response will be monitored by regular follow-up. RECIST criteria and clinical benefit will be used as criteria. In case of disease progression before end of the study period, estradiol treatment will be stopped.

Breast cancer patients with acquired anti-hormonal resistance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients with acquired anti-hormonal resistance, treated with at least 2 lines of anti-hormonal therapy

You may qualify if:

• Patients with the diagnosis of acquired anti-hormonal resistant advanced breast cancer showing progression after two or more lines of antihormonal treatment;
• Treatment with estradiol will be started;
• Age\> 18 years;
• ECOG performance status 0-2.

You may not qualify if:

• Life Expectancy \<3 months;
• Uncontrolled CNS metastases;
• History of thrombosis;
• Uncontrolled hypercalcemia;
• Treatment with any investigational drug within 30 days before start of study;
• Serious uncontrolled concurrent illness, e.g. autoimmune disorders;
• New York Hearth Association (NYHA) class III/IV congestive heart failure;
• Dyspnea at rest due to any cause;
• Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause;
• Women of childbearing potential unless a) surgically sterile or b) using adequate measures of contraception.
• Diabetes Mellitus

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Dutch Cancer Society: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (3)

• Dehdashti F, Mortimer JE, Trinkaus K, Naughton MJ, Ellis M, Katzenellenbogen JA, Welch MJ, Siegel BA. PET-based estradiol challenge as a predictive biomarker of response to endocrine therapy in women with estrogen-receptor-positive breast cancer. Breast Cancer Res Treat. 2009 Feb;113(3):509-17. doi: 10.1007/s10549-008-9953-0. Epub 2008 Mar 9.

  PMID: 18327670 BACKGROUND

• Ellis MJ, Gao F, Dehdashti F, Jeffe DB, Marcom PK, Carey LA, Dickler MN, Silverman P, Fleming GF, Kommareddy A, Jamalabadi-Majidi S, Crowder R, Siegel BA. Lower-dose vs high-dose oral estradiol therapy of hormone receptor-positive, aromatase inhibitor-resistant advanced breast cancer: a phase 2 randomized study. JAMA. 2009 Aug 19;302(7):774-80. doi: 10.1001/jama.2009.1204.

  PMID: 19690310 BACKGROUND

• Linden HM, Stekhova SA, Link JM, Gralow JR, Livingston RB, Ellis GK, Petra PH, Peterson LM, Schubert EK, Dunnwald LK, Krohn KA, Mankoff DA. Quantitative fluoroestradiol positron emission tomography imaging predicts response to endocrine treatment in breast cancer. J Clin Oncol. 2006 Jun 20;24(18):2793-9. doi: 10.1200/JCO.2005.04.3810. Epub 2006 May 8.

  PMID: 16682724 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

NL (1)