CareMore study 1: prognostic value of HER2-positive circulating tumor cells in metastatic breast cancer patients treated with aromatase inhibitors (CareMore-AI study)

CareMore study 1: prognostic value of HER2-positive circulating tumor cells in metastatic breast cancer patients treated with aromatase inhibitors (CareMore-AI study) - CareMore-AI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47479

Enrollment

300

Registered

2015-02-10

Start date

2015-03-27

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Metastatic breast cancer metastatic mammary cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female patient with metastatic breast cancer - Age >= 18 years - Written informed consent

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
The primary endpoint for this study will be the 6 months PFR in patients who had HER2-positive CTC*s at the start of AI treatment (group 1)	—

Secondary

Measure	Time frame
Secondary objectives are to determine impact of HER2 expression in CTCs taken at baseline on outcome to AIs combined with CDK4/6 inhibitors (group 1) In addition, we will investigate genomic heterogeneity within a patient on single CTC level (group 1, 2, 3)	—

Countries

Netherlands

Outcome results