We hypothezise that patients with a primary tumor expressing ER and lacking HER2 but with CTCs expressing HER2 have a worse response on hormonal therapy.
ID
Bron
Verkorte titel
Aandoening
- Borstaandoeningen
Aandoening
Breast cancer, borstkanker, HER2, ER, PIK3CA, CTC, circulating tumor cell, circulerende tumorcellen, metastasen, metastasis, AI, aromatase inhibitor, letrozole, anastrozole, arimidex, aromataseremmer
Betreft onderzoek met
Ondersteuning
Department of Medical Oncology
Onderzoeksproduct en/of interventie
- Overige
Uitkomstmaten
Primaire uitkomstmaten
To 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
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 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.
Doel van het onderzoek
We hypothezise that patients with a primary tumor expressing ER and lacking HER2 but with CTCs expressing HER2 have a worse response on hormonal therapy.
Onderzoeksopzet
- Baseline
- 6 months evaluation
Onderzoeksproduct en/of interventie
Blood draw for CTC enumeration and characterization (80 mL of blood) at baseline
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
• Age ≥ 18 years
• Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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