iquid biopsies and imaging

Completed

Conditions: breast cancer
10006291

Registration Number: NL-OMON52473

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Female patients aged 18 years or older
- Histologically proven invasive breast carcinoma
- Planned for neoadjuvant chemotherapy (and in case of a Her2-positive
tumor: addition of trastuzumab and/or pertuzumab)

Exclusion Criteria

- ER-positive, HER2-negative, B&R grade 1 breast cancer
- Inflammatory breast cancer
- Distant metastases on PET/CT
- Ipsilateral breast cancer in history (contralateral breast cancer >5 years
ago is allowed)
- Other active malignant disease in the past 5 years (excluded squamous cell or
basal cell carcinoma of the skin)
- Pregnant or lactating women.
- Contra-indications for MRI according to standard hospital guidelines.
- Contra-indications for gadolinium-based contrast-agent, including known prior
allergic reaction to any contrastagent, and renal failure, defined by GFR < 30
mL/min/1.73m2.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is Residual Breast Cancer Burden in surgical excision<br /><br>specimen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are radiological lesion volume on DCE MRI after NAC. In<br /><br>addition, ypT0/ypN0 (i.e., absence of invasive cancer and in-situ cancer in the<br /><br>breast and axillary nodes), ypT0/is ypN0 (i.e., absence of invasive cancer in<br /><br>the breast and axillary nodes, irrespective of ductal carcinoma in situ), and<br /><br>ypT0/is (i.e., absence of invasive cancer in the breast irrespective of ductal<br /><br>carcinoma in situ or nodal involvement). </p><br>