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The effect of anti-HER2 therapy in metastatic breast cancer wih HER2-negative primary tumor but HER2-positive circulating tumor cells


- candidate number21846
- NTR NumberNTR5115
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mrt-2015
- Secondary IDsNL51298.078.14 Erasmus MC MEC-2014-589
- Public TitleThe effect of anti-HER2 therapy in metastatic breast cancer wih HER2-negative primary tumor but HER2-positive circulating tumor cells
- Scientific TitleCareMoreCTC study 2: Activity of trastuzumab based chemotherapy in metastatic breast cancer patients with HER2-negative primary tumor but HER2 positive circulating tumor cells (CareMore-Trastuzumab)
- ACRONYMCareMore-Trastuzumab
- hypothesisWe hypothesize that patients with a HER2-negative primary tumor but with at least one HER2-positive CTC benefit from HER2 targeted treatment with trastuzumab
- Healt Condition(s) or Problem(s) studiedBreast cancer, HER2/neu positive, Circulating tumor cells, Metastasis
- Inclusion criteria- Female patient with metastatic breast cancer with HER2-negative primary tumor
- Age > 18 years old
- WHO performance status < 2
- Considered fit enough to receive trastuzumab/docetaxel by the treating physician
- Able to understand and give written informed consent
- Female patient with metastatic breast cancer with HER2-negative primary tumors with the presence of at least one HER2-positive CTC
- Adequate left-ventricular ejection fraction (LVEF) of at least 45%
- Exclusion criteria- Previous chemotherapy for metastatic disease.
- Adjuvant chemotherapy within 6 months prior to treatment start.
- Hormonal antitumor treatment within one week prior to treatment start.
- Symptomatic CNS metastases (the presence of at least one key symptom in combination with radiologic evidence (positive contrast-enhanced CT or MRI of the brain))
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2015
- planned closingdate1-mrt-2018
- Target number of participants103
- InterventionsScreening:
Blood collection for CTC enumeration and HER2 staining.

Study (only woman with HER2-positive CTCs are included):
- LVEF mesurement
- Blood collection for CTC isolation and in situ characterization (ER, pHER2 & PIK3CA)
- Administration of trastzumab/docetaxel in patients with at least one HER2+ CTC
- Primary outcomeDetermine if metastatic breast cancer patients with HER2-negative primary tumors but HER2-positive CTCs benefit from trastuzumab-containing chemotherapy
- Secondary outcome- Impact of pHER2 and PIK3CA mutations in CTCs on the outcome to trastuzumab based chemotherapy
- PIK3CA mutation status, pHER2 and ER expression status on primary tumor tissue to compare with CTCs
- CTCs enumerated and isolated by CellSearch to CTCs enumerated and characterized by CytoTrack
- Whether the percentage of HER2-positive CTCs is associated with outcome on trastuzumab/docetaxel
- Timepoints- Screening
- Inclusion
- 6 months respons evalution
- Trial web sitehttp://www.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 etastases. It is appreciated that tumor characteristics may differ between the primary tumor and the metastases. In addition, evidence is accumulating that there are patients with HER2-negative primary tumors who respond to trastuzumab-based chemotherapy. One group of patients with HER2-negative primary tumors who might benefit from trastuzumab-based approaches is patients with HER2-positive circulating tumor cells (CTCs). 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 patients with a HER2-negative primary tumor but with at least one HER2-positive CTC benefit from HER2 targeted treatment with trastuzumab.
- Main changes (audit trail)
- RECORD24-mrt-2015 - 26-apr-2015


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