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A Prospective Randomized Multicenter Phase III Study of Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node--the Validation of Z0011 in China


Phase 3
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Prospective Randomized Multicenter Phase III Study of Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node--the Validation of Z0011 in China


OBJECTIVES:

To determine the effects of complete axillary lymph node dissection (ALND) on survival of
patients with sentinel lymph node (SLN) metastasis of breast cancer.

OUTLINE: This is a randomized multicenter study. Before randomization, all women were
stratified according to age (≤50 years, >50 years), tumor size(≤2cm, >2cm) and research
center. All the patients underwent lumpectomy and sentinel lymph node biopsy (SLNB).
Eligible women were randomly assigned to ALND or no ALND Active Comparator: Patients undergo
axillary lymph node dissection involving removal of at least level I and II nodes.

Experimental: No surgery of axillary lymph node in this arm. All the patients were to
receive whole-breast opposing tangential-field radiation therapy. The use of adjuvant
systemic therapy was determined by the treating physician according to the recently NCCN.

Patients are followed up every 4 months for the first 2 years, every 6 months from the third
year to the fifth year, and then annually for a total of 10 years.


Inclusion Criteria:



- Female;

- Patient aged 18 years and above;

- Patient with histological proven invasive breast cancer;

- Clinical T1-T2 disease with no distant metastasis;

- Patient with clinical N0 status;

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

- Patient with positive SLNs 1~2;

- Signed consent to participate.

Exclusion Criteria:

- History of neoadjuvant chemotherapy or hormone therapy;

- History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);

- History of any other invasive cancer;

- Initial metastatic disease known;

- Pregnant women or lactating women;

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Free Survival

Outcome Description:

Time from randomization to relapse or death.

Outcome Time Frame:

Time to relapse or progression up to 10 years

Safety Issue:

No

Principal Investigator

Yong-sheng Wang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Shandong Cancer Hospital and Institute

Authority:

China: Ministry of Health

Study ID:

Z0011-China

NCT ID:

NCT01796444

Start Date:

January 2013

Completion Date:

June 2026

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Sentinel Lymph Node Biopsy
  • Axillary Lymph Node Dissection
  • Breast Neoplasms

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