Breast CancerNCT02728076
MRI-Based Preoperative Accelerated Partial Breast Irradiation
A study testing Phase II - Preoperative Radiation followed by Lumpectomy. in people with Breast Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Phase II - Preoperative Radiation followed by Lumpectomy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2016to 5 Jan 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.
- Female
- Age ≥40 years
- Estrogen receptor positive
- Patients with both her2 positive and her2 negative tumors are eligible
- Unifocal disease
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- Invasive ductal carcinoma diagnosed by core needle biopsy
- Clinically node negative both by physical exam and by ultrasound. All enlarged or abnormal appearing lymph nodes must be biopsied.
- Zubrod performance status 0-2
- Study entry must be within 120 days from initial diagnosis of breast cancer.
- Complete blood count (CBC) /differential obtained within 14 days prior to study entry, with adequate bone marrow function defined as follows: Absolute neutrophil count ≥ 1,800 cells/mm^3; Platelets ≥ 75,000 cells/mm^3; Hemoglobin ≥8.0g/dl.
- Not pregnant or lactating; willing to use acceptable forms of contraception during radiation therapy.
- Prior breast augmentation, including breast implants, is allowed.
- Patients with a prior history of contralateral breast cancer will be considered eligible if they completed all treatment (including anti-endocrine therapy) more than five years prior to registration.
- Patients must not have a prior treatment of malignancy diagnosed or treated within the past five years, with the exception of non-melanomatous skin cancer, carcinoma in situ of the cervix and contralateral breast cancer.
- Interested patients must meet with a medical oncologist prior to study entry to determine if Oncotype testing is recommended. If recommended and patient is amenable to the possibility of receiving chemotherapy, there must be adequate biopsy tissue for testing. If adequate tissue is not available for the Oncotype testing, patients who are very interested in participation may undergo additional biopsies. If a patient plans to refuse chemotherapy regardless of a high Oncotype results and elects to forgo the test, they will still be eligible for enrollment.
- Patients must have had estrogen and progesterone receptor analysis performed on the biopsy specimen prior to study entry according to current American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guideline Recommendations for hormone receptor testing. Testing for her2 neu expression must also be performed and recorded prior to study entry.
- Appropriate stage and pre-treatment evaluation for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:
- History/Physical examination, including breast exam (inspection and palpation of the breasts) with documentation of weight and Zubrod Performance Status of 0-2 within 28 days prior to study entry.
- Right and left mammography within 60 days of diagnostic biopsy establishing diagnosis.
- Evaluation of the axilla by ultrasound and biopsy of all enlarged or abnormal appearing lymph nodes within 28 days prior to study entry.
- Clip placed within the biopsy proven breast cancer, with verification of placement by mammogram.
Who cannot join
- American Joint Committee on Cancer (AJCC) clinical T3, N1-3, M1, stage IIB, stage III or stage IV breast cancer
- Prior invasive non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix, or prior contralateral breast cancer as described in 3.1.11) unless disease free and off treatment for a minimum of five years prior to study entry.
- Multifocal breast cancer
- Modified Bloom-Richardson grade 3 disease
- Estrogen receptor negative disease
- Lymphovascular space invasion noted on biopsy
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- Invasive lobular carcinoma
- Purely non-invasive breast cancer (i.e. ductal carcinoma in situ, lobular carcinoma in situ)
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Paget's disease of the nipple
- Male breast cancer
- Prior history of radiation therapy to the chest in the region of the ipsilateral breast that would result in overlap of radiation fields.
- Patients having received or having planned neoadjuvant chemotherapy or concurrent chemotherapy. A recommendation for adjuvant chemotherapy will not preclude eligibility. However, if a patient has an Oncotype score that would lead to a recommendation for systemic chemotherapy, and chemotherapy is planned to be given in the neoadjuvant setting, the patient would then be ineligible for enrollment.
- Patients who are unable to undergo magnetic resonance imaging (MRI). This could include patients with a severe allergy to gadolinium contrast or patients with renal function insufficient to receive contrast (GFR less than 30). Patients who have a minor allergy (for example, skin rash or hives) to gadolinium contrast may still be considered for enrollment. These patients would have to receive prophylactic prednisone and diphenhydramine per Medical College of Wisconsin Department of Radiology protocol. Such cases should be reviewed with the principal investigator and radiology co-chair prior to enrollment.
- History of connective tissue disorder, including lupus, dermatomyositis and scleroderma.
- Zubrod performance status of 3 or greater
- Known breast cancer gene (BRCA) mutation
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
- Patients, who under the best estimates of the treating radiation oncologist, have a life expectancy of 10 years or less.
- Patients who are pregnant.
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last six months;
- Transmural myocardial infarction within the last six months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Phase II Study of MRI-Based Preoperative Accelerated Partial Breast Irradiation
This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.
Read the detailed description
This study will examine the feasibility, complication rates, cosmetic results and local control rate of 3D conformal radiation therapy (CRT) confined to the region of the lumpectomy cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. This study also will test the feasibility of MRI-based treatment planning for preoperative accelerated partial breast irradiation and compare dosimetric data from treatment planning with patients treated on a previous institutional post-op APBI protocol. It will also look at overall survival rates. Correlative studies include measuring the changes in tumor gene expression and immune response to radiation therapy and correlate this with pathologic response.
- Conditions
- Breast Cancer
- Being tested
- Phase II - Preoperative Radiation followed by Lumpectomy.
- Keywords
- Breast Cancer, Accelerated Partial Breast Irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase II - Preoperative Radiation followed by Lumpectomy.Radiation
Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy followed by Lumpectomy | Experimental | Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy Receives: Radiation: Phase II - Preoperative Radiation followed by Lumpectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications Following
The number of subjects with one or more postoperative complications following preoperative accelerated partial breast irradiation within three months of surgery.
Measured: 3 Months
Secondary outcomes (2)
Re-excision of Tumor.
Number of subjects with re-excision following surgery.
Measured: 5 Years
Overall Survival
The number of patients alive at five years.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start29 Jul 2016
- Primary completion16 Sep 2021
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Currey, Medical College of Wisconsin
- Investigators
- Adam Currey, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728076
- Sponsor's protocol ID
- PRO26847
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2016
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of MRI-Based Preoperative Accelerated Partial Breast Irradiation
- ClinicalTrials.gov ID
- NCT02728076
- Acronym / sponsor ID
- PRO26847
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Accelerated Partial Breast Irradiation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 29 Jul 2016 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Posted 26 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.
Detailed description
This study will examine the feasibility, complication rates, cosmetic results and local control rate of 3D conformal radiation therapy (CRT) confined to the region of the lumpectomy cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. This study also will test the feasibility of MRI-based treatment planning for preoperative accelerated partial breast irradiation and compare dosimetric data from treatment planning with patients treated on a previous institutional post-op APBI protocol. It will also look at overall survival rates. Correlative studies include measuring the changes in tumor gene expression and immune response to radiation therapy and correlate this with pathologic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy followed by Lumpectomy | Experimental | Radiation: Phase II - Preoperative Radiation followed by Lumpectomy.Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.
- Female
- Age ≥40 years
- Estrogen receptor positive
- Patients with both her2 positive and her2 negative tumors are eligible
Key exclusion criteria (26 listed)
- American Joint Committee on Cancer (AJCC) clinical T3, N1-3, M1, stage IIB, stage III or stage IV breast cancer
- Prior invasive non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix, or prior contralateral breast cancer as described in 3.1.11) unless disease free and off treatment for a minimum of five years prior to study entry.
- Multifocal breast cancer
- Modified Bloom-Richardson grade 3 disease
- Estrogen receptor negative disease
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 |
|---|---|---|
| Phase II - Preoperative Radiation followed by Lumpectomy.Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician. | Radiation | Radiation Therapy followed by Lumpectomy |
Primary outcome
Postoperative Complications Following
Time frame: 3 Months
The number of subjects with one or more postoperative complications following preoperative accelerated partial breast irradiation within three months of surgery.
2 secondary outcomes
Re-excision of Tumor.
Time frame: 5 Years
Overall Survival
Time frame: 5 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Adam Currey, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase II - Preoperative Radiation followed by Lumpectomy. in people with Breast Cancer, run by Medical College of Wisconsin at 1 site 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 22 inclusion and 26 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 21 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 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Complications Following (time frame: 3 Months). 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 21 Oct 2026.