NCT04225858

Brief Summary

This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
14mo left

Started Jan 2020

Longer than P75 for not_applicable breast-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2020Jul 2027

First Submitted

Initial submission to the registry

December 4, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

5 years

First QC Date

December 4, 2019

Last Update Submit

January 8, 2020

Conditions

Breast CancerTriple Negative Breast CancerHER2-positive Breast CancerSentinel Lymph Node

Keywords

Neoadjuvant ChemotherapySentinel lymph node biopsyBreast cancerComplete response

Outcome Measures

Primary Outcomes (1)

  • Axillary recurrence

    To show that sentinel lymph node biopsy after neoadjuvant systemic therapy can be omitted in clinically node-negative HER2+ or TN breast cancer patients who achieve radiological complete response on MRI without compromising the 5 - year axillary recurrence rate (i.e, \< 6% axillary recurrences within 5 years).

    at 5 years

Secondary Outcomes (5)

  • Breast cancer specific quality of life

    at 5 years

  • Level of cancer worry

    at 5 years

  • Recurrence-free survival

    at 5 years

  • Overall survival

    at 5 years

  • Disease-specific survival

    at 5 years

Other Outcomes (3)

  • Axillary recurrence rate by pathological response

    at 5 years

  • Recurrence rate by pathological response

    at 5 years

  • Survival by pathological response

    at 5 years

Study Arms (1)

Omission of sentinel lymph node biopsy

EXPERIMENTAL

No surgical axillary staging (i.e. sentinel lymph node biopsy) will be performed.

Procedure: Omission of sentinel lymph node biopsy

Interventions

Omission of sentinel lymph node biopsyPROCEDURE

No sentinel lymph node biopsy will be performed in clinically node-negative triple-negative or HER2-positive breast cancer patients with a radiologic complete response on MRI. Participants will be asked to complete quality of life questionnaires at baseline (prior to surgery), 6 months, 1, 3 and 5 years follow-up. A control group consisting of 100 clinically node-negative patients receiving standard treatment will be used to compare QoL scores. This group consists of patients that do not wish to participate in the experimental group (i.e., no sentinel node lymph node biopsy) or patients that are not eligible.

Also known as: Quality of life assessment
Omission of sentinel lymph node biopsy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women, aged ≥ 18 years
  • Invasive HER2+ (HR+/-) or TN breast cancer
  • Primary tumor (T), clinical stage T1-3
  • Neoadjuvant systemic therapy (NST), at least 3 cycles
  • Tumor stage assessed with breast MRI before start NST
  • Clinically node-negative before start NST (no suspect ALNs on ultrasound and FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes)
  • MRI after or during NST shows radiologic complete response
  • Written and signed informed consent

You may not qualify if:

  • Primary tumor (T) clinical stage T4
  • Patients without ultrasound or FDG-PET/CT pre-NST
  • History of breast cancer ipsilateral breast
  • Synchronous contralateral breast cancer
  • Synchronous M1 disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast NeoplasmsPathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD

    Antoni van Leeuwenhoek

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD

CONTACT

+3120512m.vrancken@nki.nl

Frederieke H. van Duijnhoven, MD, PhD

CONTACT

+3120512f.v.duijnhoven@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective non-inferiority cohort, single-arm registration trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2019

First Posted

January 13, 2020

Study Start

January 1, 2020

Primary Completion

January 1, 2025

Study Completion (Estimated)

July 1, 2027

Last Updated

January 13, 2020

Record last verified: 2020-01