Breast CancerNCT00802711
3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer
A study testing 3-dimensional conformal radiation therapy and brachytherapy in people with Breast Cancer, run by Cancer Trials Ireland at 1 site in Ireland.
Trial summary
RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 50 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 3-dimensional conformal radiation therapy and brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2009to Aug 2011
- 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 50 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Pathologically proven invasive ductal carcinoma of the breast
- Stage I or II disease (pathological tumor size ≤ 3 cm, N0, M0 disease)
- No T2 (tumor size > 3 cm) or T3 disease
- No lymph node (L0) or hemangiosis (V0) invasion
- Unilateral, unifocal, and unicentric tumor without associated suspicious diffuse microcalcification in the ipsilateral or contralateral breast
- No multifocal/multicentric disease
- Previously treated with breast-conserving surgery with adequate axillary node management
- Negative surgical resection margins for tumor (invasive tumor or ductal carcinoma in situ [DCIS]) on histology
- Clearly identified primary tumor excision cavity (clips recommended) with a target lumpectomy cavity/whole breast ratio quantifiable and ≤ 25% on the post-operative CT scan
- Patients with a lumpectomy cavity/whole breast ratio 25-30% are eligible but will undergo partial breast irradiation using multi-catheter interstitial brachytherapy during study
- Breast size amenable to partial breast irradiation (i.e., > A-cup size)
- No other pathological invasive tumor or DCIS
- No associated extensive DCIS component (< 25%)
- No associated Paget's disease of the nipple
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No breast implants
- No collagen vascular disease
- No psychiatric condition or other condition that, in the opinion of the investigator, would preclude study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy
- No concurrent chemotherapy
- Sequential chemotherapy allowed
- Concurrent hormonal therapy allowed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.
RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer.
PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with stage I or stage II breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To compare the rate of successfully delivered accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial brachytherapy in women with stage I or II invasive ductal carcinoma of the breast.
- To establish potential patient participation in ongoing phase III clinical trials (e.g., NSABP-B-39, GEC-ESTRO, RAPID, MPORT, and IRMA) that compare APBI to standard whole-breast irradiation.
Secondary
- To assess acute radiation-induced toxicity in these patients as assessed by NCI CTCAE version 3.0.
- To assess long-term radiation-induced toxicity in these patients as assessed by RTOG-EORTC scale.
- To assess the incidence and type of adverse events in the breast of these patients.
- To assess the incidence and type of procedure-related complications in these patients.
- To determine local control and pattern of recurrence in these patients.
- To determine disease-free survival (distant and recurrence-free survival) of these patients.
- To determine overall survival of these patients.
- To assess cosmesis in these patients as assessed by the Breast Cancer Treatment Outcome and RTOG scales.
- To assess treatment-related symptoms in these patients as assessed by the Breast Cancer Treatment Outcome scale.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with a lumpectomy cavity/whole breast ratio 25-30% are assigned to treatment in arm II.
- Arm I: Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires at baseline, on the last day of treatment, at 4 and 24 weeks after completion of treatment, and then annually for 3 years.
After completion of study treatment, patients are followed periodically for at least 5 years.
- Conditions
- Breast Cancer
- Being tested
- 3-dimensional conformal radiation therapy, brachytherapy
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, invasive ductal breast carcinoma
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-dimensional conformal radiation therapyRadiation
Given twice a day for 10 fractions
brachytherapyRadiation
Given twice a day for 10 fractions
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. Receives: Radiation: 3-dimensional conformal radiation therapy |
| Arm II | Experimental | Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. Receives: Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successfully delivered accelerated partial breast irradiation
Measured: Never established as trial terminated
Secondary outcomes (8)
Local control and pattern of recurrence
Measured: Never established as trial terminated
Disease-free survival (distant and recurrence-free survival)
Measured: Never established as trial terminated
Overall survival
Measured: Never established as trial terminated
Quality of life (e.g., cosmesis and treatment-related symptoms) as assessed by the Breast Cancer Treatment Outcome and RTOG scales
Measured: Never established as trial terminated
Acute radiation-induced toxicity as assessed by NCI CTCAE v3.0
Measured: Never established as trial terminated
Long-term radiation-induced toxicity as assessed by RTOG-EORTC scale
Measured: Never established as trial terminated
Incidence and type of adverse events in the breast
Measured: Never established as trial terminated
Incidence and type of procedure-related complications
Measured: Never established as trial terminated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startOct 2009
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Slow accrual
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Thirion, MD, Principal investigator, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802711
- Sponsor's protocol ID
- 06-33 ICORG
- Other IDs
- ICORG-06-33, EU-20888
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2008
- Last updated
- 13 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.
- ClinicalTrials.gov ID
- NCT00802711
- Acronym / sponsor ID
- 06-33 ICORG
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, invasive ductal breast carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Oct 2009 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 5 Dec 2008 (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.
RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer.
PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with stage I or stage II breast cancer.
Detailed description
OBJECTIVES:
Primary
- To compare the rate of successfully delivered accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial brachytherapy in women with stage I or II invasive ductal carcinoma of the breast.
- To establish potential patient participation in ongoing phase III clinical trials (e.g., NSABP-B-39, GEC-ESTRO, RAPID, MPORT, and IRMA) that compare APBI to standard whole-breast irradiation.
Secondary
- To assess acute radiation-induced toxicity in these patients as assessed by NCI CTCAE version 3.0.
- To assess long-term radiation-induced toxicity in these patients as assessed by RTOG-EORTC scale.
- To assess the incidence and type of adverse events in the breast of these patients.
- To assess the incidence and type of procedure-related complications in these patients.
- To determine local control and pattern of recurrence in these patients.
- To determine disease-free survival (distant and recurrence-free survival) of these patients.
- To determine overall survival of these patients.
- To assess cosmesis in these patients as assessed by the Breast Cancer Treatment Outcome and RTOG scales.
- To assess treatment-related symptoms in these patients as assessed by the Breast Cancer Treatment Outcome scale.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with a lumpectomy cavity/whole breast ratio 25-30% are assigned to treatment in arm II.
- Arm I: Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires at baseline, on the last day of treatment, at 4 and 24 weeks after completion of treatment, and then annually for 3 years.
After completion of study treatment, patients are followed periodically for at least 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: 3-dimensional conformal radiation therapyPatients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Radiation: brachytherapyPatients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 3-dimensional conformal radiation therapyGiven twice a day for 10 fractions | Radiation | Arm I |
| brachytherapyGiven twice a day for 10 fractions | Radiation | Arm II |
Primary outcome
Rate of successfully delivered accelerated partial breast irradiation
Time frame: Never established as trial terminated
8 secondary outcomes
Local control and pattern of recurrence
Time frame: Never established as trial terminated
Disease-free survival (distant and recurrence-free survival)
Time frame: Never established as trial terminated
Overall survival
Time frame: Never established as trial terminated
Quality of life (e.g., cosmesis and treatment-related symptoms) as assessed by the Breast Cancer Treatment Outcome and RTOG scales
Time frame: Never established as trial terminated
Acute radiation-induced toxicity as assessed by NCI CTCAE v3.0
Time frame: Never established as trial terminated
Long-term radiation-induced toxicity as assessed by RTOG-EORTC scale
Time frame: Never established as trial terminated
Incidence and type of adverse events in the breast
Time frame: Never established as trial terminated
Incidence and type of procedure-related complications
Time frame: Never established as trial terminated
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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.
Pierre Thirion, MD principal investigator
Saint Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-dimensional conformal radiation therapy and brachytherapy in people with Breast Cancer, run by Cancer Trials Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 13 Apr 2026. 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 Ireland. 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?
The study was stopped early (reason given: Slow accrual). 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?
Rate of successfully delivered accelerated partial breast irradiation (time frame: Never established as trial terminated). 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 13 Apr 2026.