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
Bron
Verkorte titel
Aandoening
- Borstaandoeningen
Aandoening
Breast cancer, borstkanker, HER2, ER, PIK3CA, CTC, circulating tumor cell, circulerende tumorcellen, metastasen, metastasis, trastuzumab, herceptin, docetaxel
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Determine if metastatic breast cancer patients with HER2-negative primary tumors but HER2-positive CTCs benefit from trastuzumab-containing chemotherapy
Achtergrond van het onderzoek
Today’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.
Doel van het onderzoek
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
Onderzoeksopzet
- Screening
- Inclusion
- 6 months respons evalution
Onderzoeksproduct en/of interventie
Screening:
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
Publiek
Noortje Verschoor
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
Wetenschappelijk
Noortje Verschoor
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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%
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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))
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL4977 |
NTR-old | NTR5115 |
CCMO | NL51298.078.14 |