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

Completed

Conditions: ER-positive breast cancer
Metastatic breast cancer
10006291

Registration Number: NL-OMON43952

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

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
• Capacity of understanding and signing the informed consent brochure prior to the blood samplin

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is to detect a difference in progression-free survival<br /><br>(PFS) between patients with and without detectable ESR1 mutations in their<br /><br>plasma. </p><br>

Secondary Outcome Measures

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