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New treatment option for Breast Cancer
Official title Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy
ClinicalTrials.gov ID: NCT04109079
What this study is testing
- What it's testing
- The aim of this study is to assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18
- Male or female
- cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition (see Section 6.4.1) o Patients with occult primary invasive breast...
- FNA or core biopsy confirmed axillary nodal metastases at presentation
- Oestrogen receptor and HER2 status evaluated on primary tumour
You likely can't join if
- Participants will be excluded if they have any one of the following:
- Bilateral synchronous invasive breast cancer
- Sentinel node biopsy prior to NACT
- Previous axillary nodal surgery on the same body side as the scheduled targeted sampling
- Any previous cancer within last 5 years or concomitant malignancy except
- basal or squamous cell carcinoma of the skin
See the full eligibility criteria
- Age ≥ 18
- Male or female
- cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition (see Section 6.4.1) o Patients with occult primary invasive breast cancer (no identifiable invasive cancer in the breast) with FNA or core...
- FNA or core biopsy confirmed axillary nodal metastases at presentation
- Oestrogen receptor and HER2 status evaluated on primary tumour
- Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)
- Imaging of the axilla, as required, to assess response to NACT (per local guidelines)
- Undergo a dual tracer sentinel node biopsy (SNB) after NACT with at least 3 nodes removed.
- 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.
- If the node is not marked or the marked node is not removed: the patient is eligible only if the histology report shows evidence of down-staging with complete pathological response e.g., fibrosis or scarring in at least...
- If fewer than 3 nodes are found on histology: the patient is eligible only if BOTH points a) and b), below, are met:
- involved node was marked and removed during SNB; and
- removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.
- 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.
- No evidence of nodal metastases post NACT (isolated tumour cells, micro or macro metastasis)
- Patients with complete pathological response in the axilla but residual disease in the breast post NACT are eligible for the study
- Patients who are cN0 (node negative) at initial presentation, with a negative sentinel node post NACT showing evidence of treatment response or downstaging will be eligible, provided at least 3 nodes are removed. 5.2.
- Participants will be excluded if they have any one of the following:
- Bilateral synchronous invasive breast cancer
- Sentinel node biopsy prior to NACT
- Previous axillary nodal surgery on the same body side as the scheduled targeted sampling
- Any previous cancer within last 5 years or concomitant malignancy except
- basal or squamous cell carcinoma of the skin
- in situ carcinoma of the cervix
- in situ or stage 1 melanoma
- contra- or ipsilateral in situ breast cancer
- chronic lymphocytic leukaemia not on treatment
The study team makes the final eligibility decision.
Where it's taking place
- Dublin, Ireland
- Galway, Ireland
- Keighley, BD20 6TD, United Kingdom
- Carlisle, CA2 7HY, United Kingdom
- Camberley, GU16 7UJ, United Kingdom
- Inverness, IV2 3UJ, United Kingdom
- Great Yarmouth, NR31 6LA, United Kingdom
- Reading, RG1 5AN, United Kingdom
- Macclesfield, SK10 3BL., United Kingdom
- Shrewsbury, SY3 8XQ, United Kingdom
- Aberdeen, United Kingdom
- Ashford, United Kingdom
- Ashton-under-Lyne, United Kingdom
- Ayr, United Kingdom
- Basildon, United Kingdom
- Belfast, United Kingdom
- Birmingham, United Kingdom
- Blackpool, United Kingdom
- Bolton, United Kingdom
- Bradford, United Kingdom
+ 67 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dublin, Ireland; Galway, Ireland; Keighley, BD20 6TD, United Kingdom; Carlisle, CA2 7HY, United Kingdom; Camberley, GU16 7UJ, United Kingdom; Inverness, IV2 3UJ, United Kingdom and 81 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.