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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43952

Enrollment

Registered

2016-05-12

Start date

2017-02-14

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

ER-positive breast cancer Metastatic breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >=18 years • Postmenopausal status, being defined as: - Age >=60 years - Age =1 year ago when not treated with chemotherapy and/or endocrine treatment in the meantime - Age 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 • Capacity of understanding and signing the informed consent brochure prior to the blood samplin

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The primary end point is to detect a difference in progression-free survival (PFS) between patients with and without detectable ESR1 mutations in their plasma.	—

Secondary

Measure	Time frame
Secondary, exploratory end points are to identify mutations emerging in ctDNA during treatment and associated with progression to AI and/or everolimus and exemestane treatment, to identify genetic markers in ctDNA explaining how initially responding tumors escape drug sensitivity, and to compare the DNA mutational landscape between primary tumors, metastatic lesions, if available, and matching ctDNA at start and during treatment for metastatic disease.	—

Measure

Time frame

Secondary, exploratory end points are to identify mutations emerging in ctDNA during treatment and associated with progression to AI and/or everolimus and exemestane treatment, to identify genetic markers in ctDNA explaining how initially responding tumors escape drug sensitivity, and to compare the DNA mutational landscape between primary tumors, metastatic lesions, if available, and matching ctDNA at start and during treatment for metastatic disease.

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Countries

Netherlands

Outcome results