Breast CancerNCT02612012
Axillary Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- axillary radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 475 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2019
- Phase
- Observational
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Early stage breast cancer patients with 1~2 positive sentinel lymph nodes
Who may be able to join
- Female
- 18~70 years old
- Pathologically confirmed invasive breast cancer
- A clinical T1-2N0M0 tumor
- Treated with breast conserving surgery and sentinel lymph node biopsy
- 1~2 positive sentinel lymph nodes, including micro-metastases or macro-metastases.
- ECOG score 1~2
- Written informed consent
Who cannot join
- Patients underwent complete axillary lymph node dissection
- Patients underwent mastectomy
- Patients underwent neoadjuvant therapy
- Clinically node positive pre-operative
- Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
- Prior history of invasive breast cancer or previous or concurrent other malignancies within the past 5 years
Show all 11Show fewer
- Previous radiation therapy of breast or thorax
- Medical contraindication for radiotherapy
- Prior axillary surgery or radiotherapy
- Unable or unwilling to receive breast conserving surgery or sentinel lymph node biopsy
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Zhaozhi Yang, MD,PhD, +86 18017317126, yzzhi2014@163.com
Li Zhang, MD, +86 13818119034, zhangliaaa111@163.com
About this study
Official title: Phase II Study of Axillary Level I-II Areas Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
This study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.
Read the detailed description
Randomized clinical trials have demonstrated that complete axillary lymph node dissection is not necessary in patients with 1-2 positive sentinel lymph nodes who undergo breast conserving surgery, whole breast irradiation, and systemic therapy. However, whether or not the regional lymph node should be irradiated and if radiation given, whether or not all levels of axillary lymph node and internal mammary and supraclavicular lymph node should be irradiated is unknown. The purpose of this study is to evaluate the feasibility and safety of axillary level I-II areas radiotherapy for early stage breast cancer with 1-2 positive sentinel lymph nodes and no further axillary lymph node dissection.
- Conditions
- Breast Cancer
- Being tested
- axillary radiotherapy
- Keywords
- breast cancer, positive sentinel lymph nodes, axillary radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary radiotherapyRadiation
Whole breast irradiation and axillary level I-II areas radiotherapy. The prescription dose is 50Gy in 25 fractions in 5 weeks. Tumor bed boost is necessary with 10Gy in 5 fractions in one week.
| Study group | Role | What they receive |
|---|---|---|
| Axillary radiotherapy | Not described Receives: Radiation: axillary radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary recurrence
Measured: 5 years
Secondary outcomes (4)
Local-regional recurrence
Measured: 5 years
Disease free survival
Measured: 5 years
Overall survival
Measured: 5 years
Complications
Measured: baseline，1，2，3，4，5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Yu, Fudan University
- Investigators
- Xiaoli Yu, MD.PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612012
- Sponsor's protocol ID
- FDRT-BC002
- Status last verified
- Nov 2015
- First submitted
- 19 Nov 2015
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Axillary Level I-II Areas Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
- ClinicalTrials.gov ID
- NCT02612012
- Acronym / sponsor ID
- FDRT-BC002
- Conditions
- Breast Cancer
- Keywords
- breast cancer, positive sentinel lymph nodes, axillary radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2019 (estimated)
- First posted
- 23 Nov 2015 (estimated)
- 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.
This study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.
Detailed description
Randomized clinical trials have demonstrated that complete axillary lymph node dissection is not necessary in patients with 1-2 positive sentinel lymph nodes who undergo breast conserving surgery, whole breast irradiation, and systemic therapy. However, whether or not the regional lymph node should be irradiated and if radiation given, whether or not all levels of axillary lymph node and internal mammary and supraclavicular lymph node should be irradiated is unknown. The purpose of this study is to evaluate the feasibility and safety of axillary level I-II areas radiotherapy for early stage breast cancer with 1-2 positive sentinel lymph nodes and no further axillary lymph node dissection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axillary radiotherapy | – | Radiation: axillary radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early stage breast cancer patients with 1~2 positive sentinel lymph nodes
Key inclusion criteria (8 listed)
- Female
- 18~70 years old
- Pathologically confirmed invasive breast cancer
- A clinical T1-2N0M0 tumor
- Treated with breast conserving surgery and sentinel lymph node biopsy
Key exclusion criteria (11 listed)
- Patients underwent complete axillary lymph node dissection
- Patients underwent mastectomy
- Patients underwent neoadjuvant therapy
- Clinically node positive pre-operative
- Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
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 |
|---|---|---|
| axillary radiotherapyWhole breast irradiation and axillary level I-II areas radiotherapy. The prescription dose is 50Gy in 25 fractions in 5 weeks. Tumor bed boost is necessary with 10Gy in 5 fractions in one week. | Radiation | Axillary radiotherapy |
Primary outcome
Axillary recurrence
Time frame: 5 years
4 secondary outcomes
Local-regional recurrence
Time frame: 5 years
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Complications
Time frame: baseline，1，2，3，4，5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
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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.
Xiaoli Yu, MD.PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
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 8 inclusion and 11 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 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Xiaoli Yu, MD.PhD (+86 18017312388, stephanieyxl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axillary recurrence (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 23 Nov 2015.