Activity of trastuzumab based chemotherapy in metastatic breast patients with HER2-negative primary tumor but HER2 positive circulating tumor cells (CareMore-Trastuzumab)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004432-18-NL

Enrollment

Registered

2014-11-27

Start date

2015-02-18

Completion date

Unknown

Last updated

2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastastic breast cancer

Interventions

Trade Name: Trastuzumab Product Name: Trastuzumab Product Code: ATCL01CX03 Pharmaceutical Form: Concentrate for solution for injection/infusion Product Name: docetaxel Product Code: ATC L01CD02 Pharm

Eligibility

Sex/Gender

All

Inclusion criteria

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/docetaxel 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% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to determine if metastatic breast cancer patients with HER2-negative primary tumors but with at least one HER2-positive CTC benefit from trastuzumab-containing chemotherapy. ;Secondary Objective: Secondary objectives are to determine the impact of ER, phosphorylated HER2 (pHER2) and PIK3CA mutations in CTCs on the outcome of trastuzumab-based chemotherapy and to determine the PIK3CA mutation status, pHER2 and ER expression status on primary tumor tissue to compare with CTCs. Furthermore, two methods to enumerate and characterize CTCs will be compared.;Primary end point(s): The primary endpoint is progression free survival rate at 6 months (PFR6mth) in patients with HER2-negative primary tumor but at least one HER2-positive CTC, receiving trastuzumab/docetaxel. ;Timepoint(s) of evaluation of this end point: At 6 months after first treatment	—

Measure

Time frame

Main Objective: The primary objective is to determine if metastatic breast cancer patients with HER2-negative primary tumors but with at least one HER2-positive CTC benefit from trastuzumab-containing chemotherapy. ;Secondary Objective: Secondary objectives are to determine the impact of ER, phosphorylated HER2 (pHER2) and PIK3CA mutations in CTCs on the outcome of trastuzumab-based chemotherapy and to determine the PIK3CA mutation status, pHER2 and ER expression status on primary tumor tissue to compare with CTCs. Furthermore, two methods to enumerate and characterize CTCs will be compared.;Primary end point(s): The primary endpoint is progression free survival rate at 6 months (PFR6mth) in patients with HER2-negative primary tumor but at least one HER2-positive CTC, receiving trastuzumab/docetaxel. ;Timepoint(s) of evaluation of this end point: At 6 months after first treatment

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are the association between 6 months PFR and PIK3CA mutation status, pHER2 expression and ER expression on CTC’s. In addition, the PIK3CA mutation status, HER2 and ER expression status will be re-evaluated on the primary tumor. Furthermore, CTC enumeration and characterization done following CellSearch procedures and CytoTrack procedures, respectively, will be compared. Also it will be explored whether the percentage of HER2-positive CTCs is associated with outcome to trastuzumab.;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Secondary end point(s): Secondary endpoints are the association between 6 months PFR and PIK3CA mutation status, pHER2 expression and ER expression on CTC’s. In addition, the PIK3CA mutation status, HER2 and ER expression status will be re-evaluated on the primary tumor. Furthermore, CTC enumeration and characterization done following CellSearch procedures and CytoTrack procedures, respectively, will be compared. Also it will be explored whether the percentage of HER2-positive CTCs is associated with outcome to trastuzumab.;Timepoint(s) of evaluation of this end point: Not applicable

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Countries

Netherlands

Contacts

Public ContactM. Homs

Erasmus MC Cancer Institute

m.homs@erasmusmc.nl31107041754

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026