NCT04116125

Brief Summary

The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

October 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

October 1, 2019

Last Update Submit

October 2, 2019

Conditions

Breast Neoplasm FemaleLymphatic Metastasis

Keywords

Breast cancercN1, ycN0Neoadjuvant cheotherapySentinel Lymph NodeRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Disease free survival including breast, axilla and other organs from medical record

    5 years

Secondary Outcomes (5)

  • Local recurrence

    5 years

  • Axillary recurrence

    5 years

  • distant recurrence

    5 years

  • distant free survival

    5 years

  • Overall survival

    5 years

Other Outcomes (1)

  • Quality of life by questionnaire

    5 years

Study Arms (2)

Sentinel lymph node biopsy

PLACEBO COMPARATOR

Perform conventional sentinel lymph biopsy

Procedure: Radiotherapy

Adjuvant radiation without Sentinel lymph node biopsy

EXPERIMENTAL

Perform radiotherapy instead of sentinel lymph node biopsy

Procedure: Radiotherapy

Interventions

RadiotherapyPROCEDURE

Adjuvant radiotherapy on axillary region

Adjuvant radiation without Sentinel lymph node biopsySentinel lymph node biopsy

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women aged \> 20 years
  • cT1-3N1M0, primary invasive
  • initially confirmed ALN by fine needle aspiration cytology before neoadjuvant chemotherapy
  • completion of neoadjuvant chemotherapy
  • tumors negative for LN metastasis confirmed by imaging after neoadjuvant chemotherapy

You may not qualify if:

  • synchronous distant metastases
  • previous other malignancy
  • bilateral breast cancer
  • previous primary systemic therapy
  • pregnancy or breastfeeding
  • pre-operative radiological evidence of multiple involved or suspicious axillary nodes
  • patient with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphatic MetastasisBreast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 4, 2019

Study Start

July 1, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2025

Last Updated

October 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share