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Clinical Trials/NL-OMON43952
NL-OMON43952
Completed
Not Applicable

on-invasive monitoring of breast cancer therapy using circulating tumor DNA from peripheral blood - NAVIGATOR

Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites90 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
90
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Age \>\=18 years
  • •Postmenopausal status, being defined as:
  • •\- Age \>\=60 years
  • •\- Age \<60 years and last menstruation \>\=1 year ago when not treated with chemotherapy and/or endocrine treatment in the meantime
  • •\- Age \<60 years and postmenopausal luteinizing hormone (LH), follicle stimulating hormone (FSH), and plasma estradiol levels
  • •\- Surgical or radiation\-induced sterilization
  • •Histologically or cytologically confirmed diagnosis of metastatic breast cancer
  • •Histological confirmation of ER\-positive (\>10% of the tumor cells ER\-positive), HER2\-negative disease (1\+ staining or 2\+ non\-amplified), preferentially of the primary tumor, but otherwise of a biopsied metastatic/recurrent site
  • •Radiologically evaluable disease according to RECIST version 1\.1
  • •Willingness and capacity to follow the protocol specified visits for blood sampling for the total duration of the study

Exclusion Criteria

  • •Prior treatment in the metastatic setting with any AI
  • •For the second part of blood sampling during everolimus/exemestane: other hormonal treatment in between the AI and combination everolimus/exemestane line. Chemotherapy to contain rapidly progressing before starting everolimus/exemestane is allowed.
  • •A secondary malignancy currently present or curatively treated within the last five years before registration, except for non\-melanoma skin cancer, cervical carcinoma in situ, or bladder cancer in situ.

Outcomes

Primary Outcomes

Not specified

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