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NCT Number: NCT01717131

Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node

Data from cohorts, prospective studies and one randomized trial (ASCOG Z0011) support the hypothesis that omission of additional axillary dissection in case of positive sentinel node has a limited impact on overall survival and relapse free survival. However, these data are not sufficient enough to recommend, as a standard of care, to avoid axillary dissection in case of positive sentinel node. The ASCOG Z0011 trial has been closed before the end of inclusions and the predefined non inferiority margin was found to be too large (5% difference at 5 years for primary endpoint).

Prospective randomized trial is then urgently mandatory before omission of axillary node dissection becomes a usual practice without a sufficient scientific level of proof. Indeed, in several reviews, the rate of omission of axillary node dissection in case of micrometastasis increased (Bilimoria) despite any strong proof has been demonstrated.

The omission of axillary node dissection in case of positive sentinel node may have strong practical impacts on patients but also on medical and economical aspects: in avoiding a prolonged hospitalisation, secondary morbidities due to axillary dissection requiring secondary care and their costs, as well as costs for secondary axillary dissection (14 to 25% in case of positive sentinel node) and finally shortening surgery duration.

The main investigator propose a Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Invasive Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gilles HOUVENAEGHEL, PHD

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Patient aged 18 years and above,
  • - Patient with invasive breast cancer histologically proven or cytologically proven by fine needle biopsy,
  • - Patient with a unifocal tumor T0 - T1 - T2 up to 5 cm (clinical or in imagery), without previous therapy (neoadjuvant chemotherapy or hormone therapy),
  • - Patient with clinical N0 status,
  • - Absence of clinically detectable metastases known,

6- Patients for whom conservative surgery with sentinel lymph node (SLN) technique is feasible from the start in terms of carcinologic,

7 -All patients with lymph node involvement (GS+), whatever the size of the metastasis (macro-metastasis, micro-metastasis, cellular cluster or isolated tumor cells),

8 - Patient affiliated to a social security system or benefiting from such a system,

9 - Signed consent to participate.

Exclusion criteria

  • - Tumor of more than 5 cm
  • - Indication of neoadjuvant therapy by chemotherapy or hormone therapy
  • - History of breast cancer (ipsilateral, ie recurrence, or contralateral breast)
  • - History of any other invasive cancer other than a past cutaneous cancer correctly treated
  • - Initial metastatic disease known
  • - Presence of clinical axillary adenopathy
  • - Contra-indication to surgical excision
  • - Contra-indication to the SLN technique
  • - Pregnant women, of child-bearing potential, or lactating women

10- Patient deprived of liberty or under supervision of a guardian

11- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.

Treatment and study plan

Surgery for standard axillary node dissection

Procedure

No axillary lymph node dissection

Other

No surgery on axillary lymph node

Primary outcomes

  1. Disease Free survival

    Time frame: Time to relapse or progression up to 10 years

    time from randomization to relapse or death.

Secondary outcomes

  1. axillary recurrence rate

    Time frame: Time to local relapse up to 10 years

    Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.

  2. Overall survival

    Time frame: Time to death up to 10 years

    Time from randomization to date of death

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

A Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer

Important dates

Study start
2012
Primary completion
2021
Study completion
2031
First posted
Oct 30, 2012
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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