Breast CancerPhase 32009-APBINCT01185132
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
A Phase 3 study testing accelerated partial breast irradiation - 3D-conformal planning and accelerated partial breast irradiation - IMRT planning in people with Breast Cancer, run by Rocky Mountain Cancer Centers at 5 sites in United States.
Trial summary
In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- accelerated partial breast irradiation - 3D-conformal planning and accelerated partial breast irradiation - IMRT planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2009to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.
- Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
- Negative surgical margins ( ≥ 0.2 cm) after final surgery.
- Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.
- Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
- Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.
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- Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
- Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4.
- Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.
- PTV to ipsilateral breast ratio (IBR) ≤ 25 %.
- Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.
Who cannot join
- Pregnancy or breast-feeding.
- Have collagen-vascular disease.
- Inadequate surgical margins ( < 0.2 cm) after final surgery.
- Subjects with persistent malignant/suspicious micro-calcifications.
- Gross multifocal disease and microscopic disease greater than 3.0 cm.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Charles Leonard, MD contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012
Dennis Carter, MD
William Daniel, MD
- Recruiting
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, 80303
Andrew Antell, MD
Meera Patel, MD
- Recruiting
Rocky Mountain Cancer Centers - Lakewood
Lakewood, Colorado, 80228
Ralph Wright, MD
Charles Leonard, MD
- Recruiting
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, 80120
Charles Leonard, MD
Kathryn Howell, MD
- Recruiting
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, 80260
Robert LaPorte, MD
Daniel Chin, MD
About this study
Official title: A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.
- Conditions
- Breast Cancer
- Being tested
- accelerated partial breast irradiation - 3D-conformal planning, accelerated partial breast irradiation - IMRT planning
- Keywords
- breast-conservation, adjuvant radiotherapy, breast cancer, early-stage breast cancer, DCIS, lumpectomy, accelerated partial breast irradiation, APBI, three dimensional conformal external radiotherapy, intensity modulated radiotherapy, 3D CRT, IMRT
- 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.
accelerated partial breast irradiation - 3D-conformal planningRadiation
Also called APBI, EBRT
38.5 Gy, 10 fractions over 5 days
accelerated partial breast irradiation - IMRT planningRadiation
Also called APBI, EBRT
38.5 Gy, 10 fractions over 5 days
| Study group | Role | What they receive |
|---|---|---|
| IMRT | Experimental | Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days Receives: Radiation: accelerated partial breast irradiation - IMRT planning |
| 3D-CRT | Active comparator | Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days Receives: Radiation: accelerated partial breast irradiation - 3D-conformal planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Measured: 5 years
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Measured: 2-5 years
Secondary outcomes (7)
Dosimetric comparison
Comparison of treatment plans and actual doses received between comparable patients treated with 3D-CRT and IMRT with regard to treatment target and normal tissue
Measured: 5-10 days
Acute skin reactions
Radiation-induced dermatitis
Measured: 6 months
Cosmetic outcomes after APBI
Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit
Measured: 2-5 years
Ipsilateral breast event
Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)
Measured: 5-15 years
Cause specific survival
Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)
Measured: 5-15 years
Disease free survival
Track breast-cancer free survival status of study participants (efficacy outcome measure)
Measured: 5-15 years
Overall survival
Track the overall survival status of all study participants (efficacy outcome measure)
Measured: 5-15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startJul 2009
- Primary completionJul 2018 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain Cancer Centers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Leonard, MD, Principal investigator, Rocky Mountain Cancer Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185132
- Sponsor's protocol ID
- 2009-APBI
- Other IDs
- WIRB #20091193
- Acronym
- 2009-APBI
- Status last verified
- Jun 2014
- First submitted
- 18 Aug 2010
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Leonard CE, Wang Y, Asmar L, Lei RY, Howell KT, Henkenberns PL, Johnson TK, Hobart TL, Tole SP, Kercher JM, Widner JL, Barke L, Kaske T, Carter DL. A prospective Phase III trial evaluating patient self-reported pain and cosmesis in accelerated partial breast irradiation utilizing 3-D versus intensity-modulated radiotherapy. Cancer Med. 2021 Oct;10(20):7089-7100. doi: 10.1002/cam4.4242. Epub 2021 Sep 1.
PubMed 34469056
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
- ClinicalTrials.gov ID
- NCT01185132
- Acronym / sponsor ID
- 2009-APBI / 2009-APBI
- Conditions
- Breast Cancer
- Keywords
- breast-conservation, adjuvant radiotherapy, breast cancer, early-stage breast cancer, DCIS, lumpectomy, accelerated partial breast irradiation, APBI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Rocky Mountain Cancer CentersUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Aug 2010 (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.
In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMRT | Experimental | Radiation: accelerated partial breast irradiation - IMRT planningIntensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days |
| 3D-CRT | Active comparator | Radiation: accelerated partial breast irradiation - 3D-conformal planningThree dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.
- Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
- Negative surgical margins ( ≥ 0.2 cm) after final surgery.
- Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.
- Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
Key exclusion criteria (5 listed)
- Pregnancy or breast-feeding.
- Have collagen-vascular disease.
- Inadequate surgical margins ( < 0.2 cm) after final surgery.
- Subjects with persistent malignant/suspicious micro-calcifications.
- Gross multifocal disease and microscopic disease greater than 3.0 cm.
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 |
|---|---|---|
| accelerated partial breast irradiation - 3D-conformal planningAlso: APBI, EBRT38.5 Gy, 10 fractions over 5 days | Radiation | 3D-CRT |
| accelerated partial breast irradiation - IMRT planningAlso: APBI, EBRT38.5 Gy, 10 fractions over 5 days | Radiation | IMRT |
Primary outcome
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Time frame: 5 years
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
Time frame: 2-5 years
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
7 secondary outcomes
Dosimetric comparison
Time frame: 5-10 days
Acute skin reactions
Time frame: 6 months
Cosmetic outcomes after APBI
Time frame: 2-5 years
Ipsilateral breast event
Time frame: 5-15 years
Cause specific survival
Time frame: 5-15 years
Disease free survival
Time frame: 5-15 years
Overall survival
Time frame: 5-15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Derived from this study: PubMed 34469056Leonard CE, Wang Y, Asmar L, Lei RY, Howell KT, Henkenberns PL, Johnson TK, Hobart TL, Tole SP, Kercher JM, Widner JL, Barke L, Kaske T, Carter DL. A prospective Phase III trial evaluating patient self-reported pain and cosmesis in accelerated partial breast irradiation utilizing 3-D versus intensity-modulated radiotherapy. Cancer Med. 2021 Oct;10(20):7089-7100. doi: 10.1002/cam4.4242. Epub 2021 Sep 1.
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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.
Charles Leonard, MD contact
Charles Leonard, MD principal investigator
Rocky Mountain Cancer Centers
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing accelerated partial breast irradiation - 3D-conformal planning and accelerated partial breast irradiation - IMRT planning in people with Breast Cancer, run by Rocky Mountain Cancer Centers at 5 sites in United States.
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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Lei, BS (303-418-7607, rachel.lei@usoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01185132, which also lists 1 linked publication.
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 26 Jun 2014; AzTrials last refreshed its copy on 26 Oct 2026.