Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node - Full Text View

Purpose

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

Condition	Intervention	Phase
Invasive Breast Cancer	Procedure: Surgery for standard axillary node dissection Other: No axillary lymph node dissection	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:

Disease Free survival [ Time Frame: Time to relapse or progression up to 10 years ]
time from randomization to relapse or death.

Secondary Outcome Measures:

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.
Overall survival [ Time Frame: Time to death up to 10 years ]
Time from randomization to date of death


Estimated Enrollment:	3000
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2025
Estimated Primary Completion Date:	July 2025 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Surgery for standard axillary node dissection Standard axillary dissection	Procedure: Surgery for standard axillary node dissection
Experimental: No axillary lymph node dissection No surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial)	Other: No axillary lymph node dissection No surgery on axillary lymph node

Eligibility


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

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717131

Contacts


Contact: Dominique GENRE, MD	33 (0)4 91 22 37 78	drci.up@ipc.unicancer.fr
Contact: Sandra COURNIER	33 (0)4 91 22 37 78	drci.up@ipc.unicancer.fr

Locations


France
Gilles HOUVENAEGHEL, PHD	Recruiting
Marseille, France, 13009
Contact: Gilles HOUVENAEGHEL, PhD 33(0)491223778 drci.up@ipc.unicancer.fr

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators


Principal Investigator:	Gilles HOUVENAEGHEL, MD, PHD	Institut Paoli-Calmettes

More Information

Additional Information:

official web site of the sponsor This link exits the ClinicalTrials.gov site


Responsible Party:	Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:	NCT01717131 History of Changes
Other Study ID Numbers:	SERC / IPC 2012-001
Study First Received:	October 19, 2012
Last Updated:	August 29, 2016

Keywords provided by Institut Paoli-Calmettes:


Invasive breast cancer

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

ClinicalTrials.gov processed this record on June 22, 2017