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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Amit
Goyal
+44 (0)1332 785538
amit.goyal@nhs.net
Miss
Sophie
Cramp
+44 (0)2476524438
ATNEC@warwick.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Breast cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Background and study aims
Early-stage breast cancer patients with abnormal-looking armpit lymph glands on an ultrasound scan will have a sample (needle biopsy) of this lymph gland taken. If the sample shows cancer cells are present, patients are often given chemotherapy before surgery (called neoadjuvant chemotherapy) to shrink these cancer cells before their operation. Currently after chemotherapy, all patients undergo breast surgery (lumpectomy or mastectomy) and treatment to their armpit (either removal of all armpit lymph glands or radiotherapy to the armpit).
Neoadjuvant chemotherapy results in complete disappearance of cancer in the lymph glands in around 40-70% of patients. For these patients there may be no extra benefit from more treatment to their armpit. Any extra armpit treatment may damage lymphatic drainage from the arm, which could lead to arm swelling (lymphoedema), restricted shoulder movement, pain, numbness and other sensory problems. These side effects make some daily activities difficult for patients, they are distressing and affect their quality of life. They are costly to the NHS in terms of treatments such as physiotherapy and attendance at lymphoedema clinics.
The aim of this study is to find out whether stopping further armpit treatment for patients with no cancer in the lymph glands after chemotherapy is safe, in terms of risk of cancer coming back and fewer lymphoedema cases at 5 years. After neoadjuvant chemotherapy and at the time of breast surgery, patients will undergo removal of at least three lymph glands from the armpit. If there is no cancer in the removed glands, patients will be randomly allocated to receive standard armpit treatment or no further treatment to the armpit.
Results of this study could benefit patients by avoiding unnecessary treatment to the armpit and thus reducing future problems with the arm and shoulder, and possibly improved quality of life and reduced healthcare costs.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
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 (isolat
You may not be able to take part if:
Current exclusion criteria as of 19/07/2023:
1. Bilateral synchronous invasive breast cancer2. Sentinel node biopsy prior to NACT3. Previous axillary surgery on the same body side as the scheduled targeted sampling4. Any previous cancer within 5 years or concomitant malignancy except:4.1. Basal or squamous cell carcinoma of the skin4.2. In situ carcinoma of the cervix4.3. In situ melanoma4.4. Contra- or ipsilateral in situ breast cancer
_____
Previous exclusion criteria:
1. Bilateral invasive breast cancer2. Sentinel node biopsy prior to NACT3. Marked node not removed except where the node/s removed show evidence of down-staging with complete pathological response e.g. fibrosis or scarring4. Previous axillary surgery on the same body side as the scheduled targeted sampling5. Any previous cancer within 5 years or concomitant malignancy except:5.1. Basal or squamous cell carcinoma of the skin5.2. In situ carcinoma of the cervix5.3. In situ melanoma5.4. Contra- or ipsilateral in situ breast cancer
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Amit
Goyal
+44 (0)1332 785538
amit.goyal@nhs.net
Miss
Sophie
Cramp
+44 (0)2476524438
ATNEC@warwick.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University Hospitals of Derby and Burton NHS Foundation Trust and funded by National Institute for Health Research; Grant Codes: NIHR128311.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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