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
Source
Brief title
Condition
- Breast disorders
Health condition
Breast cancer, borstkanker, HER2, ER, PIK3CA, CTC, circulating tumor cell, circulerende tumorcellen, metastasen, metastasis, AI, aromatase inhibitor, letrozole, anastrozole, arimidex, aromataseremmer
Research involving
Sponsors and support
Department of Medical Oncology
Intervention
- Other intervention
Outcome measures
Primary outcome
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
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
Background summary
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.
Study objective
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.
Study design
- Baseline
- 6 months evaluation
Intervention
Blood draw for CTC enumeration and characterization (80 mL of blood) at baseline
Noortje Verschoor
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
Noortje Verschoor
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
Age
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4884 |
| NTR-old | NTR5121 |
| CCMO | NL50622.078.14 |
| OMON | NL-OMON47479 |