Breast CancerNCT02617082
Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery
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 partial breast irradiation for low risk DCIS after breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- partial breast irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 828 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2019
- How long will I take part?
- 5 Years
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: DCIS breast cancer patients
Who may be able to join
- Female
- 18~65 years old
- Pathologically confirmed DCIS, low- or intermediate- grade DCIS: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade DCIS: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3)
- Treated with breast conserving surgery
- Tumor bed is labeled with Titanium clips
- No malignancy history
- ECOG score 0~1
- Written informed consent
Who cannot join
- DCIS of both breast
- invasive breast cancer
- Multicentric disease
- Patients underwent mastectomy
- Previous radiation therapy of breast
- Medical contraindication for radiotherapy
- Pregnant or nursing
- suspicious calcification after surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaoli Yu, MD,PhD, +86 13817893133, stephanieyxl@hotmail.com
Xiaofang Wang, MD, +86 18818211606, xiaofang0708@yeah.net
About this study
Official title: Phase II Study of Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery
This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.
Read the detailed description
Randomized clinical trials have demonstrated that the recurrence of DCIS is low and most of the recurrence occurs around the tumor bed. Besides, cosmetic outcomes are reported better in partial breast irradiation group compared to whole breast irradiation group. However, whether or not partial breast irradiation is safety in DCIS is still unknown. The purpose of this study is to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.
- Conditions
- Breast Cancer
- Being tested
- partial breast irradiation
- Keywords
- breast cancer, partial breast irradiation, DCIS
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial breast irradiationRadiation
The prescription dose is 40.5Gy in 15 fractions in 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| partial breast irradiation | Not described Receives: Radiation: partial breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ipsilateral breast tumor recurrence
Measured: 5 years
Secondary outcomes (5)
occurrence of contralateral breast tumor after PBI
Measured: 5 years
Disease free survival
Measured: 5 years
Overall survival
Measured: 5 years
radiation-induced toxicity of breast assessed by CTCAE v4.0
Measured: baseline, 3 months, 6 months, and every half year to 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 posted30 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
- 828 participants (estimated)
- Target duration
- 5 Years
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
- NCT02617082
- Sponsor's protocol ID
- FDRT-BC004
- Status last verified
- Nov 2015
- First submitted
- 21 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery
- ClinicalTrials.gov ID
- NCT02617082
- Acronym / sponsor ID
- FDRT-BC004
- Conditions
- Breast Cancer
- Keywords
- breast cancer, partial breast irradiation, DCIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 828 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2019 (estimated)
- First posted
- 30 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 partial breast irradiation for low risk DCIS after breast-conserving surgery.
Detailed description
Randomized clinical trials have demonstrated that the recurrence of DCIS is low and most of the recurrence occurs around the tumor bed. Besides, cosmetic outcomes are reported better in partial breast irradiation group compared to whole breast irradiation group. However, whether or not partial breast irradiation is safety in DCIS is still unknown. The purpose of this study is to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| partial breast irradiation | – | Radiation: partial breast irradiation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- DCIS breast cancer patients
Key inclusion criteria (8 listed)
- Female
- 18~65 years old
- Pathologically confirmed DCIS, low- or intermediate- grade DCIS: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade DCIS: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3)
- Treated with breast conserving surgery
- Tumor bed is labeled with Titanium clips
Key exclusion criteria (8 listed)
- DCIS of both breast
- invasive breast cancer
- Multicentric disease
- Patients underwent mastectomy
- Previous radiation therapy of breast
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 |
|---|---|---|
| partial breast irradiationThe prescription dose is 40.5Gy in 15 fractions in 3 weeks. | Radiation | partial breast irradiation |
Primary outcome
ipsilateral breast tumor recurrence
Time frame: 5 years
5 secondary outcomes
occurrence of contralateral breast tumor after PBI
Time frame: 5 years
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
radiation-induced toxicity of breast assessed by CTCAE v4.0
Time frame: baseline, 3 months, 6 months, and every half year to 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 30 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 8 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 30 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?
ipsilateral breast tumor 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 30 Nov 2015.