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Prognostic value of HER2-positive circulating tumor cells in metastatic breast cancer patients treated with aromatase inhibitors


- candidate number21875
- NTR NumberNTR5121
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2015
- Secondary IDsNL50622.078.14 Erasmus MC MEC-2014-588
- Public TitlePrognostic value of HER2-positive circulating tumor cells in metastatic breast cancer patients treated with aromatase inhibitors
- Scientific TitleCareMoreCTC study 1: Prognostic value of HER2-positive circulating tumor cells in metastatic breast cancer patients treated with aromatase inhibitors (CareMore-AI study)
- ACRONYMCareMore-AI study
- hypothesisWe hypothezise that patients with a primary tumor expressing ER and lacking HER2 but with CTCs expressing HER2 have a worse response on hormonal therapy.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Circulating tumor cells, Aromatase inhibitor, Metastasis
- Inclusion criteria• Female patient with metastatic breast cancer
• Age ≥ 18 years
• Written informed consent
- Exclusion criteria• Adjuvant chemotherapy within 6 months prior to treatment start
• Other anticancer chemotherapy, use of biological response modifiers, or immunotherapy within two weeks prior to treatment start. Hormonal antitumor treatment within one week prior to treatment start.
• Serious illness or medical unstable condition prohibiting adequate treatment and follow-up
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2015
- planned closingdate1-mrt-2018
- Target number of participants182
- InterventionsBlood draw for CTC enumeration and characterization (80 mL of blood) at baseline
- Primary outcomeTo determine the impact of HER2 expression in CTCs taken at baseline on outcome to AIs in metastatic breast cancer patients with an ER-positive primary tumor
- Secondary outcome- To determine impact of PIK3CA mutation status, pHER2 and ER expression status in CTCs taken at baseline on outcome to AIs
- To determine the PIK3CA mutation status, pHER2 and ER expression status on primary tumor tissue to compare with CTCs
- To compare CTCs enumerated and isolated by CellSearch to CTCs enumerated and characterized by CytoTrack
- To explore whether the percentage of HER2-positive CTCs is associated with outcome on AIs
- Timepoints- Baseline
- 6 months evaluation
- Trial web sitewww.caremorectc.eu
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. S. Sleijfer
- CONTACT for SCIENTIFIC QUERIESProf. Dr. S. Sleijfer
- Sponsor/Initiator Erasmus MC Cancer Institute, department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
EU FP 7
- Publications
- Brief summaryToday’s treatment of metastatic breast cancer is guided by characteristics of the primary tumor, while 90% of deaths due to breast cancer occur as a consequence of metastases. Treatment of metastatic breast cancer patients with hormonal agents is often employed in the clinic. A worse outcome to hormonal therapy was observed in patients with primary tumors expressing both ER and HER2 compared to patients with primary tumors positive for ER but negative for HER2. Metastatic breast cancer patients are still treated based on primary tumor characteristics, while it is now increasingly appreciated that important characteristics like ER and HER2 expression may differ between the primary tumor and the metastatic lesion. Circulating tumor cells (CTCs) are cancer cells present in the peripheral blood of patients with metastatic breast cancer and are thought to represent characteristics of the metastases. We hypothesize that HER2 status on CTCs will be stronger associated with outcome to hormonal therapy than HER2 status in primary tumors. If so, this means that patients with primary tumors expressing ER and lacking HER2, but with CTCs expressing HER2, should not be treated with hormonal agents.
- Main changes (audit trail)
- RECORD27-mrt-2015 - 26-apr-2015


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