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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02401685
Recruitment Status : Active, not recruiting
First Posted : March 30, 2015
Last Update Posted : September 16, 2021
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, University Hospitals of Derby and Burton NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE March 11, 2015
First Posted Date  ICMJE March 30, 2015
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE August 1, 2014
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
  • 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.
  • Quality of life [ Time Frame: 3 years ]
    Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire.
  • Anxiety (Spielberger State/Trait Anxiety Inventory) [ Time Frame: 3 years ]
    Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory.
  • 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.
  • Local (breast or chest wall) recurrence [ Time Frame: 5 years ]
    Number of participants with local (breast or chest wall) recurrence.
  • Regional (nodal) recurrence [ Time Frame: 5 years ]
    Number of participants with regional (nodal) recurrence.
  • Distant metastasis [ Time Frame: 5 years ]
    Number of participants with distant metastasis.
  • Time to axillary recurrence [ Time Frame: 5 years ]
  • Axillary recurrence free survival [ Time Frame: 5 years ]
  • Disease free survival [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 5 years ]
  • Contralateral breast cancer [ Time Frame: 5 years ]
    Number of participants with contralateral breast cancer.
  • Non-breast malignancy [ Time Frame: 5 years ]
    Number of participants with non-breast malignancy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Adjuvant therapy
  • 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.
    Interventions:
    • Other: Adjuvant therapy
    • Procedure: Axillary treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 27, 2015)		 1900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02401685
Other Study ID Numbers  ICMJE RD-5103-001-13
ISRCTN Number ( Registry Identifier: ISRCTN54765244 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr Amit Goyal, University Hospitals of Derby and Burton NHS Foundation Trust
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospitals of Derby and Burton NHS Foundation Trust
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Amit Goyal University Hospitals of Derby and Burton NHS Foundation Trust
PRS Account University Hospitals of Derby and Burton NHS Foundation Trust
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP