Activity of trastuzumab based chemotherapy in metastatic breast cancer patients with HER2-negative primary tumor but HER2 positive circulating tumor cells

Phase 2

Completed

Conditions: metastastic mammary cancer
metastatic breast cancer
10006291

Registration Number: NL-OMON46900

Lead Sponsor: Interne Oncologie

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

Screening:
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/taxane-based chemotherapy by the treating physician
Able to understand and give written informed consent;Secondary inclusion criteria:
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is progression free survival rate at 6 months (PFR6mth) in<br /><br>patients with HER2-negative primary tumor but at least one HER2-positive CTC,<br /><br>receiving trastuzumab/taxane-based chemotherapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the association between 6 months PFR and PIK3CA<br /><br>mutation status, pHER2 expression and ER expression on CTC*s. In addition, the<br /><br>PIK3CA mutation status, HER2 and ER expression status will be re-evaluated on<br /><br>the primary tumor. Furthermore, CTC enumeration and characterization done<br /><br>following CellSearch procedures and CytoTrack procedures, respectively, will be<br /><br>compared. Lastly, it will be explored whether the % of HER2-positive CTCs<br /><br>correlates with response to trastuzumab/taxane-based chemotherapy.</p><br>