Breast Neoplasm FemaleOBSERBNCT04116125
Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial
A study testing Radiotherapy in people with Breast Neoplasm Female and Lymphatic Metastasis, run by Kyungpook National University Chilgok Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Lymphatic Metastasis
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,380 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: A Randomized Trial of Sentinel Lymph Node Biopsy vs Radiotherapy Alone After Neoadjuvant Chemotherapy in Patients Undergoing Breast Conserving Surgery With cT1-3N1, ycN0 Breast Cancer
The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.
Read the detailed description
The OBSERB study aims to compare the oncologic outcomes of radiotherapy without sentinel lymph node biopsy versus sentinel lymph node biopsy for the management of breast cancer which showed the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
To verify whether, the radiotherapy without SLN can be applied, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
To verify whether, the additional treatment decision can be established based on only the biology of primary tumor without the pathologic information of axillary lymph nodes To verify whether, the patients' quality of life can be improved by a less invasive surgical procedure, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
- Conditions
- Breast Neoplasm Female, Lymphatic Metastasis
- Being tested
- Radiotherapy
- Keywords
- Breast cancer, cN1, ycN0, Neoadjuvant cheotherapy, Sentinel Lymph Node, Radiotherapy
- Medical subject headings
- Lymphatic Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyProcedure or surgery
Adjuvant radiotherapy on axillary region
| Study group | Role | What they receive |
|---|---|---|
| Sentinel lymph node biopsy | Placebo comparator | Perform conventional sentinel lymph biopsy Receives: Procedure: Radiotherapy |
| Adjuvant radiation without Sentinel lymph node biopsy | Experimental | Perform radiotherapy instead of sentinel lymph node biopsy Receives: Procedure: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease free survival including breast, axilla and other organs from medical record
Measured: 5 years
Secondary outcomes (5)
Local recurrence
Ipsilateral breast from medical record
Measured: 5 years
Axillary recurrence
Ipsilateral axillary lymph nodes from medical record
Measured: 5 years
distant recurrence
Other organs except ipsilateral breast and axillary lymph nodes from medical record
Measured: 5 years
distant free survival
No disease on other organs except ipsilateral breast and axillary lymph nodes from medical record
Measured: 5 years
Overall survival
Overall survival from medical record
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Jul 2020 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Chilgok Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Breast Cancer Study Group
- Responsible party
- Principal investigator, JeeYeon Lee, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116125
- Sponsor's protocol ID
- 2019-09-023
- Acronym
- OBSERB
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Sentinel Lymph Node Biopsy vs Radiotherapy Alone After Neoadjuvant Chemotherapy in Patients Undergoing Breast Conserving Surgery With cT1-3N1, ycN0 Breast Cancer
- ClinicalTrials.gov ID
- NCT04116125
- Acronym / sponsor ID
- OBSERB / 2019-09-023
- Conditions
- Breast Neoplasm Female, Lymphatic Metastasis
- Keywords
- Breast cancer, cN1, ycN0, Neoadjuvant cheotherapy, Sentinel Lymph Node, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,380 participants (estimated)
- Lead sponsor
- Kyungpook National University Chilgok HospitalUniversity, hospital or other
- Collaborators
- Korean Breast Cancer Study Group
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.
Detailed description
The OBSERB study aims to compare the oncologic outcomes of radiotherapy without sentinel lymph node biopsy versus sentinel lymph node biopsy for the management of breast cancer which showed the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
To verify whether, the radiotherapy without SLN can be applied, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
To verify whether, the additional treatment decision can be established based on only the biology of primary tumor without the pathologic information of axillary lymph nodes To verify whether, the patients' quality of life can be improved by a less invasive surgical procedure, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel lymph node biopsy | Placebo comparator | Procedure: RadiotherapyPerform conventional sentinel lymph biopsy |
| Adjuvant radiation without Sentinel lymph node biopsy | Experimental | Procedure: RadiotherapyPerform radiotherapy instead of sentinel lymph node biopsy |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- synchronous distant metastases
- previous other malignancy
- bilateral breast cancer
- previous primary systemic therapy
- pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyAdjuvant radiotherapy on axillary region | Procedure or surgery | Adjuvant radiation without Sentinel lymph node biopsy, Sentinel lymph node biopsy |
Primary outcome
Disease-free survival
Time frame: 5 years
Disease free survival including breast, axilla and other organs from medical record
5 secondary outcomes
Local recurrence
Time frame: 5 years
Axillary recurrence
Time frame: 5 years
distant recurrence
Time frame: 5 years
distant free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with Breast Neoplasm Female and Lymphatic Metastasis, run by Kyungpook National University Chilgok Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.