ATNEC - Axillary management in T1-3N1M0 breast cancer patients with needle biopsy-proven nodal metastases at presentation after neoadjuvant chemotherapy
- Conditions
- Breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN36585784
- Lead Sponsor
- niversity Hospitals of Derby and Burton NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1900
Current inclusion criteria as of 05/02/2024:
1. Age =18 years
2. Male or female
3. cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition
3.2 Patients with occult primary invasive breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy provide nodal metastases are also eligible for the study.
4. FNA or core biopsy confirmed axillary nodal metastases at presentation
5. Oestrogen receptor and HER2 status evaluated on primary tumour
6. Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)
7. Imaging of the axilla, as required, to assess response to NACT (per local guidelines)
8. Undergo a dual tracer sentinel node biopsy (SNB) after NACT with at least 3 nodes removed in total (sentinel nodes and marked node).
8.1 If a single tracer SNB is performed: the patient is eligible only if the involved node is marked before or during NACT, and at least 3 nodes (including the marked node) are removed during sentinel node biopsy.
8.2 If the node is not marked, or marked node is not removed: the patient is eligible only if the histology report shows evidence of downstaging with complete pathological response e.g. fibrosis or scarring in at least one node and at least 3 nodes removed.
8.3 If fewer than 3 nodes are found on histology: the patient is eligible only if BOTH points a) and b), below, are met:
a) involved node was marked and removed during SNB; and
b) removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.
8.4 If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if at least 3 nodes are removed (including the marked node).
9. No evidence of nodal metastases post NACT (isolated tumour cells, micro or macrometastasis)
_____
Previous inclusion criteria as of 19/07/2023 to 05/02/2024:
1. Age =18 years
2. Male or female
3. cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition
4. FNA or core biopsy confirmed axillary nodal metastases at presentation
5. Oestrogen receptor, progesterone receptor and HER2 status evaluated on primary tumour
6. Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)
7. Imaging of the axilla to assess response to NACT (as per local guidelines)
8. Undergo dual tracer sentinel node biopsy after NACT and at least 3 nodes removed (sentinel nodes and marked node).
8.1 If a single tracer is used, the patient will be eligible if the involved node is marked before or during NACT, and the marked node and at least 3 nodes (including the marked node) are removed during sentinel node biopsy.
8.2 If axillary node sampling is performed following failed localisation of sentinel nodes, patient will be eligible if at least three nodes removed (including the marked node).
8.3 If node is not marked, or marked node is not removed, the patient will be eligible if the histology report shows evidence of downstaging with complete pathological response e.g. fibrosis or scarring in at least one node and at least 3 nodes removed.
8.4 If fewer than 3 nodes are found on histology, the patient is eligible if: a) involved node was marked and removed during SNB; and b) removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.
9. No evidence of nodal metastases
Current exclusion criteria as of 19/07/2023:
1. Bilateral synchronous invasive breast cancer
2. Sentinel node biopsy prior to NACT
3. Previous axillary surgery on the same body side as the scheduled targeted sampling
4. Any previous cancer within 5 years or concomitant malignancy except:
4.1. Basal or squamous cell carcinoma of the skin
4.2. In situ carcinoma of the cervix
4.3. In situ melanoma
4.4. Contra- or ipsilateral in situ breast cancer
_____
Previous exclusion criteria:
1. Bilateral invasive breast cancer
2. Sentinel node biopsy prior to NACT
3. Marked node not removed except where the node/s removed show evidence of down-staging with complete pathological response e.g. fibrosis or scarring
4. Previous axillary surgery on the same body side as the scheduled targeted sampling
5. Any previous cancer within 5 years or concomitant malignancy except:
5.1. Basal or squamous cell carcinoma of the skin
5.2. In situ carcinoma of the cervix
5.3. In situ melanoma
5.4. Contra- or ipsilateral in situ breast cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Co-primary outcomes, collected annually for 5 years:<br>1. Disease-Free Survival (DFS); defined and calculated as the time from randomisation until the date of the first event of either a loco-regional invasive breast cancer relapse, distant relapse, ipsilateral or contralateral new invasive primary breast cancer or death by any cause or the censor date<br>2. Lymphoedema: self-reported based on two items from the validated Lymphoedema and Breast Cancer Questionnaire (LBCQ) (arm swelling now” and arm heaviness in the past year”). Lymphoedema will be defined as ‘yes’ to both questions at 5 years.
- Secondary Outcome Measures
Name Time Method