POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer (NCT02401685) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
Australia, New Zealand, United Kingdom1,900 participantsStarted 2014-08-01
Plain-language summary
POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial.
Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years.
Stratification: Institution, Age (\<50, ≥50), Breast-conserving surgery (BCS) or mastectomy, Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2), Intra-operative sentinel assessment using OSNA (yes, no).
Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)).
Sample Size: 1900 participants
Follow-up: Participants will be followed up for 5 years.
Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant therapy alone.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unifocal or multi-focal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or largest invasive tumour diameter on radiology should be used for women who are randomised intra-operatively or undergo sentinel node biopsy before neoadjuvant therapy (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci)
* At sentinel node biopsy have 1 or 2 nodes with macrometastases (tumour deposit \>2.0mm in largest dimension or defined as macrometastasis on molecular assay)
* Fit for axillary treatment and adjuvant therapy
* Have given written informed consent
Exclusion Criteria:
* bilateral invasive breast cancer
* more than 2 nodes with macrometastases
* neoadjuvant therapy for breast cancer except:
* if sentinel node biopsy performed prior to neoadjuvant chemotherapy in women with early breast cancer
* short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months)
* previous axillary surgery on the same body side as the scheduled sentinel node biopsy
* not receiving adjuvant systemic therapy
* previous cancer less than 5 years previously or concomitant malignancy except:
* basal or squamous cell carcinoma of the skin
* in situ carcinoma of the cervix
* in situ melanoma
* contra- or ipsilateral in situ breast cancer
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Axillary recurrence
Timeframe: 5 years
Trial details
NCT IDNCT02401685
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust