A randomized trial of armpit (axilla) treatment for women with early stage breast cancer. POSNOC - POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy.
| ISRCTN | ISRCTN54765244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54765244 |
| IRAS number | 137785 |
| ClinicalTrials.gov number | NCT02401685 |
| Secondary identifying numbers | 16069, RD-5103-001-13, IRAS 137785 |
- Submission date
- 25/02/2014
- Registration date
- 25/02/2014
- Last edited
- 01/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Amit Goyal
Scientific
Scientific
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
 ORCID ID |
0000-0002-2381-8337 |
|---|---|
| Phone | +44 (0)1332 785538 |
| amit.goyal@nhs.net |
Study information
| Study design | Pragmatic randomised multi-centre non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Available in resources and publications section of trial website http://www.posnoc.co.uk/ |
| Scientific title | POSNOC - POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomized controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes |
| Study acronym | POSNOC |
| Study objectives | Current study hypothesis as of 14/06/2019: The hypothesis of the POSNOC trial is that low axillary tumour burden patients with macrometastases in 1 or 2 sentinel nodes, receiving systemic therapy, would have non-inferior outcomes whether they are randomised to adjuvant therapy alone or adjuvant therapy plus axillary treatment (either axillary node clearance or axillary radiotherapy). Previous hypothesis: The hypothesis of the POSNOC trial is that low axillary tumour burden patients (clinically and ultrasound node negative) with macrometastases in 1 or 2 sentinel nodes, receiving systemic therapy, would have non-inferior outcomes whether they are randomised to adjuvant therapy alone or adjuvant therapy plus axillary treatment (axillary node clearance or axillary radiotherapy). |
| Ethics approval(s) | Nottingham Research Ethics Committee 2, 13/EM/0459, First REC approval date 02/01/2014 |
| Health condition(s) or problem(s) studied | Breast Cancer |
| Intervention | Current interventions as of 14/06/2019: The trial interventions are either: 1. Adjuvant therapy alone (intervention) Axillary radiotherapy is not allowed when randomised to this group. 2. Adjuvant therapy plus axillary treatment (standard care) Axillary treatment can be either axillary node clearance or axillary radiotherapy as per local guidelines. All participants will have adjuvant therapy according to local guidelines. Adjuvant therapy will include chemotherapy and/or endocrine therapy for all women, and radiotherapy to breast or chest wall if indicated. Human epidermal growth factor receptor 2 (HER2) targeted treatment may be administered when indicated. Previous interventions: The trial interventions are either: 1. Adjuvant therapy alone (intervention) Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to this group. 2. Adjuvant therapy plus axillary treatment (standard care) Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines. All participants will have adjuvant therapy according to local guidelines. Adjuvant therapy will include chemotherapy and/or endocrine therapy for all women, and radiotherapy to breast or chest wall if indicated. Human epidermal growth factor receptor 2 (HER2) targeted treatment may also be administered when indicated. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Adjuvant therapy |
| Primary outcome measure | Axillary recurrence; Timepoint(s): at 5 years |
| Secondary outcome measures | 1. Anxiety; Timepoint(s): assessed at 3, 6, 12, 24, 36 months 2. Arm morbidity; Timepoint(s): assessed at 3, 6, 12, 24 and 36 months 3. Axillary recurrence free survival; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 4. Contralateral breast cancer; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 5. Disease free survival; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 6. Distant metastasis; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 7. Economic evaluation; Timepoint(s): assessed at 3, 6, 12, 24, 36 months 8. Local (breast or chest wall) recurrence; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 9. Non-breast malignancy; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 10. Overall survival; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 11. Quality of life; Timepoint(s): assessed at 3, 6, 12, 24, 36 months 12. Regional (nodal) recurrence; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 13. Time to axillary recurrence; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months |
| Overall study start date | 01/01/2014 |
| Completion date | 13/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 1900 |
| Total final enrolment | 1900 |
| Key inclusion criteria | Current inclusion criteria as of 14/06/2019: Women will be eligible for inclusion only if ALL of the following criteria apply: 1. 18 years or older 2. 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) 3. 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) 4. Fit for axillary treatment and adjuvant therapy 5. Have given written informed consent Previous inclusion criteria: Women will be eligible for inclusion only if ALL of the following criteria apply: 1. 18 years or older 2. Unifocal or multifocal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or for women who are randomised intraoperatively largest tumour diameter on mammogram or ultrasound. 3. No axillary nodal metastasis on clinical and ultrasound examination. 4. At sentinel node biopsy have 1 or 2 sentinel nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay) 5. Fit for axillary treatment and adjuvant therapy 6. Have given written informed consent |
| Key exclusion criteria | Current exclusion criteria as of 14/06/2019: Women will be excluded if they have: 1. Bilateral invasive breast cancer 2. More than 2 nodes with macrometastases 3. Neoadjuvant therapy for breast cancer except: 3.1. If sentinel node biopsy performed prior to neoadjuvant therapy in women with early breast cancer 3.2. Short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months) 4. Previous axillary surgery on the same body side as the scheduled sentinel node biopsy 5. Not receiving adjuvant systemic therapy 6. Previous cancer less than 5 years previously or concomitant malignancy except: 6.1. Basal or squamous cell carcinoma of the skin or 6.2. In situ carcinoma of the cervix or 6.3. In situ melanoma 6.4. Contra- or ipsilateral in situ breast cancer Previous exclusion criteria: Women will be excluded if they have: 1. Bilateral breast cancer 2. More than 2 sentinel node macrometastases or extranodal invasion 3. Neoadjuvant therapy for breast cancer 4. Previous axillary surgery on the same body side as the scheduled sentinel node biopsy 5. Not fit or eligible to receive adjuvant systemic therapy 6. Previous or concomitant malignancy except: 6.1. Adequately treated basal or squamous cell carcinoma of the skin or 6.2. Adequately treated in situ carcinoma of the cervix or 6.3. Adequately treated in situ melanoma 6.4. Contra- or ipsilateral in situ breast cancer |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 13/07/2021 |
Locations
Countries of recruitment
- Australia
- England
- New Zealand
- United Kingdom
Study participating centre
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
University Hospitals of Derby and Burton NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Dr Teresa M. Grieve
Assistant Director of Research & Development
Research & Development Department
Royal Derby Hospital
Derby
DE22 3DT
England
United Kingdom
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
National Health and Medical Research Council
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | 31/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 02/12/2021 | 06/12/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/11/2023: The following changes have been made:
1. IRAS number added.
2. Drug/device/biological/vaccine name(s) added.
3. Study website added.
06/12/2021: The following changes have been made:
1. Publication reference added.
2. The ClinicalTrials.gov number has been added.
12/08/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2021 to 13/07/2021.
2. The overall trial end date has been changed from 31/12/2026 to 13/07/2026.
3. The intention to publish date has been added.
4. The total final enrolment number has been added.
24/02/2020: The overall trial end date was changed from 31/12/2023 to 31/12/2026.
17/06/2019: Publication and dissemination plan and IPD sharing statement added.
14/06/2019: The following changes were made to the trial record:
1. Contact details, hypothesis, participant information sheet, interventions, inclusion/exclusion criteria were updated.
2. The recruitment end date was changed from 31/12/2023 to 31/08/2021.
3. Australia and New Zealand were added to the countries of recruitment.
4. The sponsor name was changed from "Derby Hospital NHS Foundation Trust" to "University Hospitals of Derby and Burton NHS Foundation Trust".
5. National Health and Medical Research Council (Australia) was added as a funder.
