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
ID
Source
Brief title
Condition
- Breast disorders
Health condition
Breast cancer, borstkanker, HER2, ER, PIK3CA, CTC, circulating tumor cell, circulerende tumorcellen, metastasen, metastasis, trastuzumab, herceptin, docetaxel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determine 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
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 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.
Study objective
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
Study design
- Screening
- Inclusion
- 6 months respons evalution
Intervention
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
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 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))
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 | NL4977 |
| NTR-old | NTR5115 |
| CCMO | NL51298.078.14 |
| OMON | NL-OMON46900 |