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POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer (POSNOC)

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ClinicalTrials.gov Identifier: NCT02401685
Recruitment Status : Recruiting
First Posted : March 30, 2015
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
University of Nottingham
Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
NCRI Radiotherapy Trials QA Group (RTTQA)
Breast Cancer Trials, Australia and New Zealand
Information provided by (Responsible Party):
Dr Amit Goyal, Derby Hospitals NHS Foundation Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: Adjuvant therapy Procedure: Axillary treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: POSNOC - POsitive Sentinel NOde: Adjuvant Therapy Alone Versus Adjuvant Therapy Plus Clearance or Axillary Radiotherapy. A Randomised Controlled Trial of Axillary Treatment in Women With Early Stage Breast Cancer Who Have Metastases in One or Two Sentinel Nodes
Study Start Date : January 2014
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Adjuvant therapy alone
Women in this arm will have adjuvant therapy but no treatment to their armpit after surgery. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to this arm.
Other: Adjuvant therapy
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.

Active Comparator: Adjuvant therapy plus axillary treatment
Women in this arm will have adjuvant therapy plus treatment to their armpit after surgery. Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
Other: Adjuvant therapy
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.

Procedure: Axillary treatment
Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.




Primary Outcome Measures :
  1. Axillary recurrence [ Time Frame: 5 years ]
    Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.


Secondary Outcome Measures :
  1. Arm morbidity [ Time Frame: 3 years ]
    Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires.

  2. Quality of life [ Time Frame: 3 years ]
    Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire.

  3. Anxiety (Spielberger State/Trait Anxiety Inventory) [ Time Frame: 3 years ]
    Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory.

  4. Economic evaluation (EQ-5D-5L (EuroQoL) [ Time Frame: 3 years ]
    Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument.

  5. Local (breast or chest wall) recurrence [ Time Frame: 5 years ]
    Number of participants with local (breast or chest wall) recurrence.

  6. Regional (nodal) recurrence [ Time Frame: 5 years ]
    Number of participants with regional (nodal) recurrence.

  7. Distant metastasis [ Time Frame: 5 years ]
    Number of participants with distant metastasis.

  8. Time to axillary recurrence [ Time Frame: 5 years ]
  9. Axillary recurrence free survival [ Time Frame: 5 years ]
  10. Disease free survival [ Time Frame: 5 years ]
  11. Overall survival [ Time Frame: 5 years ]
  12. Contralateral breast cancer [ Time Frame: 5 years ]
    Number of participants with contralateral breast cancer.

  13. Non-breast malignancy [ Time Frame: 5 years ]
    Number of participants with non-breast malignancy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401685


Contacts
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Contact: Amit Goyal amit.goyal@nhs.net

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Sponsors and Collaborators
Derby Hospitals NHS Foundation Trust
University of Nottingham
Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
NCRI Radiotherapy Trials QA Group (RTTQA)
Breast Cancer Trials, Australia and New Zealand
Investigators
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Principal Investigator: Amit Goyal Derby Hospitals NHS Foundation Trust

Additional Information:
Publications:
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Responsible Party: Dr Amit Goyal, Consultant Oncoplastic Breast Surgeon & Associate Professor, Derby Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02401685     History of Changes
Other Study ID Numbers: RD-5103-001-13
ISRCTN Number ( Registry Identifier: ISRCTN54765244 )
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Keywords provided by Dr Amit Goyal, Derby Hospitals NHS Foundation Trust:
breast cancer
sentinel lymph node biopsy
axillary lymph node clearance
axillary lymph node dissection
macrometastases
axillary radiotherapy
POSNOC

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases