Liquid biopsies and imaging

Liquid biopsies and imaging - LIMA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52473

Enrollment

100

Registered

2019-08-23

Start date

2020-12-17

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary end point is Residual Breast Cancer Burden in surgical excision specimen.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results