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VENUS: Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer

Sponsor
University of Campinas, Brazil (Other)
Overall Status
Recruiting
CT.gov ID
NCT05315154
Collaborator
(none)
800
Enrollment
14
Locations
2
Arms
132
Anticipated Duration (Months)
57.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The VENUS trial is a prospective, multicenter, noninferiority, randomized, controlled clinical trial that compares sentinel lymph node biopsy versus no axillary surgery in women with early breast cancer (tumor <5cm) and node-negative after clinical palpation and axillary ultrasound.

Condition or Disease Intervention/Treatment Phase
  • Procedure: No axillary surgery
  • Procedure: SLNB
 N/A

Detailed Description

The standard approach to women with early breast cancer (BC) and clinically negative nodes is sentinel lymph node dissection (SLND). Studies showed that axillary lymph node dissection (ALND) can be safely omitted in presence of positive sentinel lymph node in patients treated with breast conserving therapy.Therefore, the pertinence of SLND in the approach to women with early BC is being questioned, once it is not injury-free.

The ACOSOG Z0011 trial examined the safety of omitting ALND in patients with early BC and up to 2 positive nodes at SLND, undergoing conservative surgery plus breast radiotherapy. The 10-year worth of data from this trial strongly suggested that omitting the procedure in these restrict, well-selected, subsets of patients maybe safe. Neoadjuvant chemotherapy (NAC) may be the starting treatment step for women with aggressive BC subtypes even in early stages.The SENTINA and ACOSOG Z1071 trials revealed that for women with three or more negative nodes in SLND, the procedure's accuracy and false-negative rate lie within acceptable boundaries. Our hypothesis is that for patients with early BC (regardless of neoadjuvant systemic therapy), with clinically and ultrasound negative axilla, avoiding SLND may be safe from the oncological perspective.The VENUS trial will investigate whether there may be still room for further de-escalation of the approach to the axilla in well-selected subsets of BC patients, by including women for whom the de-escalation has not been tested in previous trials dealing with the subject.

The VENUS trial is a prospective, noninferiority, multicenter, randomized controlled clinical trial that was approved by the Local Research Ethic Committee .The trial will compare SLND with no axillary surgery in women with T1-2 invasive BC and N0 disease, as ascertained after clinical palpation and axillary ultrasound. Mastectomy and primary systemic therapy are allowed whether node negative previous start the treatment . All women accrued to the trial must sign the informed consent. Randomization 1:1 will be stratified by age (≤50 and >50 years old) and clinical tumor size (≤2 cm and >2 cm).

The sample size estimated is 364 women in each arm (400 to account for losses to follow-up). Sample size was calculated according to the following parameters: 90% disease-free survival in patients undergoing SLND and a minimum 85% in those not undergoing the procedure, 80% power and 95% confidence intervals, with a tolerated risk ratio of 0.8. After surgery, regardless of adjuvant therapies, and for at least 48 months, patients will undergo physical examination of their breasts and axilla every 6 months and mammography will be performed annually or at closer intervals if indicated. Adjuvant chemotherapy and radiotherapy will be performed according to the protocol of each participating center and patients without axillary surgery should be considered N0 for decision making.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer Clinically and Ultrasonographically Node-negative
Actual Study Start Date :
Oct 2, 2019
Anticipated Primary Completion Date :
Oct 2, 2025
Anticipated Study Completion Date :
Oct 2, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: No axillary surgery

Procedure: No axillary surgery
In the study arm will be omitted surgery in axilla
Active Comparator: Sentinel lymph node biopsy

Procedure: SLNB
in the control arm will be realized SLNB

Outcome Measures

Primary Outcome Measures

  1. Disease free survival (DFS) [5 years]

    Interval between the end of treatment and the diagnosis of any disease recurrence (breast, axilla or distant) by image exams or biopsy

Secondary Outcome Measures

  1. Overall survival (OS) [5 years]

    Defined time period between the end of treatment and the patient's death from any cause.

  2. Locoregional free survival [5 years]

    Interval between the end of treatment and the diagnosis of any recorrence locoregional (breast or axilla) by biopsy

  3. Axillary recurrence rate [5 years]

    Percentage of patients with disease recurrence in axilla by biopsy in each grup

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Women

  • Aged 18 years or older

  • Histologically confirmed invasive breast carcinoma (core or open biopsy), independent of hormone receptor and HER2 status

  • Tumor smaller than 5 cm (T1 or T2) in clinical and radiological exams

  • Clinically negative axilla

  • Sonographically negative axilla or negative core biopsy/ fine needle biopsy (FNB) when ultrasound is suspect (lymph node tissue is required in core/FNB sample)

  • Planned breast conservative surgery or mastectomy

  • Written informed consent

Exclusion Criteria:

  • Previous diagnostic of any invasive neoplasia (excluded skin cancer no melanoma)

  • Metastatic disease in biopsy or image before treatment

  • Withdrawal from participating of the study

  • Initiated treatment for current breast cancer prior to study enrollment

  • Pregnancy

  • Breastfeed

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Geral de Fortaleza Fortaleza CE Brazil
2 Maternidade Dona Iris Goiânia GO Brazil
3 Universidade Federal de Goiás Goiânia GO Brazil
4 Hospital de Clínica da Universidade Federal de Minas Gerais Belo Horizonte MG Brazil
5 Hospital do Câncer de Muriaé da Fundação Cristiano Varella Muriaé MG Brazil
6 Hospital Barão de Lucena Recife PE Brazil
7 Universidade Federal do Paraná Curitiba PR Brazil
8 Hospital Federal da Lagoa Rio De Janeiro RJ Brazil
9 Liga Norte Riograndense Contra o Câncer Natal RN Brazil
10 Hospital de Clínicas de Porto Alegre - UFRS Porto Alegre RS Brazil
11 Hospital de Amor - Fundação Pio XII Barretos SP Brazil
12 Unesp Botucatu SP Brazil
13 Hospital Celso Pierro - PUCC Campinas SP Brazil
14 Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP Campinas SP Brazil

Sponsors and Collaborators

  • University of Campinas, Brazil

Investigators

  • Principal Investigator: Giuliano Duarte, MD, PhD, Universidade Estadual de Campinas, Unicamp

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Giuliano Mendes Duarte, MD PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT05315154
Other Study ID Numbers:
  • 06805118.2.1001.5404
  • RBR-8g6jbf
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Giuliano Mendes Duarte, MD PhD, University of Campinas, Brazil
Breast cancer
Sentinel Lymph Node
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Apr 7, 2022