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This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy
Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omission of sentinel lymph node biopsy | Experimental | No surgical axillary staging (i.e. sentinel lymph node biopsy) will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omission of sentinel lymph node biopsy | Procedure | No sentinel lymph node biopsy will be performed in clinically node-negative triple-negative or HER2-positive breast cancer patients with a radiologic complete response on MRI. Participants will be asked to complete quality of life questionnaires at baseline (prior to surgery), 6 months, 1, 3 and 5 years follow-up. A control group consisting of 100 clinically node-negative patients receiving standard treatment will be used to compare QoL scores. This group consists of patients that do not wish to participate in the experimental group (i.e., no sentinel node lymph node biopsy) or patients that are not eligible. |
| Measure | Description | Time Frame |
|---|---|---|
| Axillary recurrence | To show that sentinel lymph node biopsy after neoadjuvant systemic therapy can be omitted in clinically node-negative HER2+ or TN breast cancer patients who achieve radiological complete response on MRI without compromising the 5 - year axillary recurrence rate (i.e, < 6% axillary recurrences within 5 years). | at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Breast cancer specific quality of life | To compare study participants in whom sentinel lymph node biopsy is omitted to patients with sentinel lymph node biopsy on breast cancer related quality of life, especially axillary morbidity score. This is measured with the EORTC-BR23 scale. The arm morbidity score consists of 3 items, points ranging from 1 - 4 per item. A higher score indicates more morbidity. |
| Measure | Description | Time Frame |
|---|---|---|
| Axillary recurrence rate by pathological response | To assess 5-year axillary recurrence-free survival in patients with and without a pathological complete response | at 5 years |
| Recurrence rate by pathological response |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD | Contact | +3120512 | 2978 | m.vrancken@nki.nl |
| Frederieke H. van Duijnhoven, MD, PhD | Contact | +3120512 | 6170 | f.v.duijnhoven@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD | Antoni van Leeuwenhoek | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Prospective non-inferiority cohort, single-arm registration trial
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| at 5 years |
| Level of cancer worry | To compare study participants in whom sentinel lymph node biopsy is omitted to patients with sentinel lymph node biopsy on level of cancer worry, using the cancer worry scale (CWS). The CWS consists of 8 items, with 1-4 points per item and a maximum score of 32 points. Higher scores indicate more frequent cancer worry. | at 5 years |
| Recurrence-free survival | To assess 5-year recurrence-free survival in clinically node-negative HER2+ or TN patients with radiologic complete response on MRI in whom sentinel lymph node biopsy is omitted. | at 5 years |
| Overall survival | To assess 5-year overall survival in clinically node-negative HER2+ or TN patients with radiologic complete response on MRI in whom sentinel lymph node biopsy is omitted. | at 5 years |
| Disease-specific survival | To assess 5-year disease specific survival in clinically node-negative HER2+ or TN patients with radiologic complete response on MRI in whom sentinel lymph node biopsy is omitted. | at 5 years |
To assess 5-year recurrence-free survival in patients with and without a pathological complete response
| at 5 years |
| Survival by pathological response | To assess 5-year survival in patients with and without a pathological complete response | at 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |