Breast CancerPhase 2NCT01203839
Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer
A Phase 2 study testing multiple beams utilizing either intensity-modulated or 3D-conformal techniques in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- multiple beams utilizing either intensity-modulated or 3D-conformal techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2010to Sep 2027
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age ≥ 18 years
- Unicentric Stage I (T1N0M0) invasive ductal breast cancer or Grade 1 or II DCIS measuring <2 cm on pathology and/or mammogram that is histologically confirmed at MSKCC
- Histologically negative tumor margin 2 mm or more from any inked edges or no tumor in a re-excision specimen or final shaved specimen
- ECOG Performance Status of 0 or 1
- Granulocytes ≥1,500/μl and platelet count must be ≥100,000/μl at the beginning of therapy for patients treated with adjuvant chemotherapy
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- Women >70 years or older with T1 invasive ductal carcinoma who are estrogen-receptor positive (ER+) with clinically negative axillary nodes and do not undergo surgical lymph node evaluation are eligible if patient will take hormonal therapy.
- Patients with T1N0(i+) tumors on sentinel lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible.
- Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery.
Who cannot join
- Patients with distant metastasis.
- Patients who are pregnant or breastfeeding.
- Patients with diffuse (>1 quadrant or >5 cm) suspicious microcalcifications.
- Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
- Histological evidence of lymphovascular invasion (LVI). Cases termed focally suspicious for LVI but where no definitive LVI is found are eligible.
- Histologic evidence of EIC, defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion.
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- Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. However, in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study. It would be an extremely rare/unlikely scenario for patients to be discovered BRCA positive after the completion of PBI, as all patients with risk factors for BRCA mutations (positive family history, Ashkenazi Jewish descent, ER-/PR-/her2-neu negative receptor status) are usually tested prior to radiation. Should such a situation exist, these patients will not receive additional RT and the patient will be replaced in the trial.
- History of cosmetic or reconstructive breast surgery.
- Psychiatric illness that would prevent the patient from giving informed consent.
- Patients for whom the delivery of PBI is not feasible
- Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have "currently active" malignancies if they have completed therapy and are considered by their physicians to be at <5% risk of relapse within 3 years.
- Patients who are already enrolled in or planning to enroll in other adjuvant systemic therapy protocols for both non-invasive or invasive breast cancer.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memorial Sloan Kettering at Basking Ridge (Follow-up Only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk (Follow-up Only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Follow-up Only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Follow-up Only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Follow-up Only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center (Follow-up Only)
Rockville Centre, New York
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Phase II Study of Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer
Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast.
However the investigators do not know if the whole breast needs to be receive radiation to better control your cancer or only a more limited area of the breast surrounding the tumor. The purpose of this study is to see the side effects of delivering partial breast irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the area of the breast where the cancer was removed. Another purpose of this study is to look long term at the rate at which cancer comes back in the same breast after PBI.
Read more
WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a day, five days a week, for 2 weeks.
In this study the investigators will learn about the good and bad effects of PBI radiation therapy. In this study, the investigators will also learn about how the breast looks after surgery and radiation therapy.
- Conditions
- Breast Cancer
- Being tested
- multiple beams utilizing either intensity-modulated or 3D-conformal techniques
- Keywords
- stage 1 breast cancer, invasive ductal breast, Partial Breast Irradiation (PBI), radiation, 10-114
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple beams utilizing either intensity-modulated or 3D-conformal techniquesRadiation
A dose of 40 Gy will be delivered to the tumor bed plus 1.5-2 cm margin. Treatment will be delivered once daily, 5 days a week, for approximately 2 weeks. Radiation therapy will begin within a minimum of 4 weeks and a maximum of 3 months from definitive surgical procedure and 2-6 weeks after chemotherapy, if chemotherapy given first. Prior to radiation, patients will receive a lumpectomy with an assessment of axillary lymph node status (for invasive tumors only). Axillary assessment may be any combination of sentinel lymph node biopsy or axillary lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| Radiation treatment | Experimental | This is a Phase II single-arm study of PBI with external-beam radiation therapy in which a group of select women with early-stage invasive and noninvasive breast cancer will be given radiation to the partial breast. Receives: Radiation: multiple beams utilizing either intensity-modulated or 3D-conformal techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of PBI-directed external-beam radiation therapy
In selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions for two weeks.
Measured: Two weeks
Secondary outcomes (3)
To evaluate local control rates
(local control for patients with DCIS will be analyzed separately from those patients with invasive cancer)
Measured: 1 year
To evaluate distant control rates
Measured: 1 year
To evaluate breast cosmesis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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 Memorial Sloan Kettering Cancer CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Powell, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203839
- Sponsor's protocol ID
- 10-114
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2010
- Last updated
- 7 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer
- ClinicalTrials.gov ID
- NCT01203839
- Acronym / sponsor ID
- 10-114
- Conditions
- Breast Cancer
- Keywords
- stage 1 breast cancer, invasive ductal breast, Partial Breast Irradiation (PBI), radiation, 10-114
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Sep 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.
Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast.
However the investigators do not know if the whole breast needs to be receive radiation to better control your cancer or only a more limited area of the breast surrounding the tumor. The purpose of this study is to see the side effects of delivering partial breast irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the area of the breast where the cancer was removed. Another purpose of this study is to look long term at the rate at which cancer comes back in the same breast after PBI.
WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a day, five days a week, for 2 weeks.
In this study the investigators will learn about the good and bad effects of PBI radiation therapy. In this study, the investigators will also learn about how the breast looks after surgery and radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation treatment | Experimental | Radiation: multiple beams utilizing either intensity-modulated or 3D-conformal techniquesThis is a Phase II single-arm study of PBI with external-beam radiation therapy in which a group of select women with early-stage invasive and noninvasive breast cancer will be given radiation to the partial breast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Age ≥ 18 years
- Unicentric Stage I (T1N0M0) invasive ductal breast cancer or Grade 1 or II DCIS measuring <2 cm on pathology and/or mammogram that is histologically confirmed at MSKCC
- Histologically negative tumor margin 2 mm or more from any inked edges or no tumor in a re-excision specimen or final shaved specimen
- ECOG Performance Status of 0 or 1
Key exclusion criteria (13 listed)
- Patients with distant metastasis.
- Patients who are pregnant or breastfeeding.
- Patients with diffuse (>1 quadrant or >5 cm) suspicious microcalcifications.
- Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
- Histological evidence of lymphovascular invasion (LVI). Cases termed focally suspicious for LVI but where no definitive LVI is found are eligible.
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 |
|---|---|---|
| multiple beams utilizing either intensity-modulated or 3D-conformal techniquesA dose of 40 Gy will be delivered to the tumor bed plus 1.5-2 cm margin. Treatment will be delivered once daily, 5 days a week, for approximately 2 weeks. Radiation therapy will begin within a minimum of 4 weeks and a maximum of 3 months from definitive surgical procedure and 2-6 weeks after chemotherapy, if chemotherapy given first. Prior to radiation, patients will receive a lumpectomy with an assessment of axillary lymph node status (for invasive tumors only). Axillary assessment may be any combination of sentinel lymph node biopsy or axillary lymph node dissection. | Radiation | Radiation treatment |
Primary outcome
To evaluate the safety of PBI-directed external-beam radiation therapy
Time frame: Two weeks
In selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions for two weeks.
3 secondary outcomes
To evaluate local control rates
Time frame: 1 year
To evaluate distant control rates
Time frame: 1 year
To evaluate breast cosmesis
Time frame: 1 year
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 7 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Simon Powell, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing multiple beams utilizing either intensity-modulated or 3D-conformal techniques in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 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 9 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
To evaluate the safety of PBI-directed external-beam radiation therapy (time frame: Two weeks). 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 7 Oct 2026.