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

Phase 1

• Conditions: Metastastic breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004432-18-NL
• Lead Sponsor: Erasmus MC Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-27
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 37

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

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 clinical trial of medicinal product
• Study Design: Not specified