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

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

UnknownPhase Unknown

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This trial is comparing the effect of having adjuvant therapy on its own, or in combination with axillary treatment, in women with metastatic breast cancer.
 

This trial is treating patients with breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Other Non-Commercial Sponsor

Melbourne Health

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="">

Recruiting Hospitals Read MoreRead more

Box Hill Hospital, Breast Oncology
Box Hill
Ms Lauren Mitchell
lauren.mitchell@monash.edu
03 9094 9544

Maroondah Hospital, Maroondah Breast Clinic
Ringwood East
Ms Lauren Mitchell
lauren.mitchell@monash.edu
03 9094 9544

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Not Recruiting Hospitals Read MoreRead more

Closed

Monash Health, Medical Oncology
Clayton
Ms Karen Gillett
Karen.Gillett@monashhealth.org
(03) 8572 2018

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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