Early-stage Breast CancerPhase 1NCT07178665
Pilot Trial of Preop Partial Radiation in Breast Cancer Patients
A Phase 1 study testing Radiation: Accelerated Partial Breast Irradiation (APBI) in people with Early-stage Breast Cancer and Breast Carcinoma, run by Rutgers, The State University of New Jersey at 10 sites in United States.
Trial summary
The purpose of our study is to assess the feasibility of preoperative partial breast (APBI) radiation in breast cancer patients. The primary outcome is the acute wound complication rate. We also aim to evaluate cosmetic outcomes and late toxicities as secondary objectives. Read more about this study
- Who is it for?
- Ages 50 to 90 years, women only
- Conditions the study is for
- Early-stage Breast Cancer, Breast Carcinoma, DCIS
- What is being tested?
- Radiation: Accelerated Partial Breast Irradiation (APBI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Sep 2025to 1 Jun 2028
- Phase
- Phase 1
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients with biopsy-proven invasive ductal cancer or DCIS Tumor size ≤ 2cm clinically and radiographically Estrogen-receptor positive (ER+) on biopsy Grade 1 or 2 on biopsy Clinically and radiographically node-negative disease No indication of metastatic disease Age >50 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Negative serum pregnancy test if applicable Willingness to participate in the clinical trial and adhere to the study protocol Ability to understand and consent to the study
Who cannot join
- Indication for neoadjuvant chemotherapy or hormone therapy Tumor size >2cm clinically or radiographically ER- on biopsy G3 invasive cancer or DCIS on biopsy Lobular histology Multicentric/multifocal tumor BRCA+ gene mutation Prior ipsilateral breast or thoracic RT Contraindication for baseline MRI Contraindication for surgery Distant metastatic disease Other synchronous cancer (besides bilateral breast) Contraindication to Radiation therapy (presence of scleroderma or other collagen vascular disease) Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, 07109
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, 07202
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, 08690
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740
Jack and Sheryl Morris Cancer Center
New Brunswick, New Jersey, 08901
RWJBarnabas Health Newark Beth Israel Medical Center
Newark, New Jersey, 07112
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerset, New Jersey, 08873
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
About this study
Official title: A Pilot Prospective Trial to Assess the Feasibility of Preoperative Partial Breast Radiation in Breast Cancer Patients
The purpose of our study is to assess the feasibility of preoperative partial breast (APBI) radiation in breast cancer patients. The primary outcome is the acute wound complication rate. We also aim to evaluate cosmetic outcomes and late toxicities as secondary objectives. Another goal is to examine the histopathology of tumors before and after radiation to assess the response and other immunologic and/or molecular changes to the tumor and its environment elicited by the radiation treatment. We hope that this will guide future trials that could change practice in specific patient subgroups.
Read the detailed description
Our primary objective is to demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic and clinically node negative breast cancer or DCIS who are eligible for BCS and treated with pre-operative partial breast irradiation (PBI) at 1 month is no worse than the rates in the current standard of care (6-20%). Our secondary objective is to demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated WBI (around 35% reported poor/fair cosmesis at 3 years, Shaitelman et al.). Tertiary objectives are to measure acute and late radiation-related toxicities, such as radiation dermatitis, telangiectasia, and fibrosis, in this cohort of patients and to measure biologic markers that radiation may influence.
To measure the pre-operative APBI clinical target volume (CTV) and compare it to the post-op APBI CTV volume that would have been contoured as CTV if the partial breast was to be delivered post-operatively.
To measure the incidence of fair/poor patient-reported cosmetic outcomes using the BCTOS cosmetic scale.
To study cancer biology before and after radiation treatment.
- Conditions
- Early-stage Breast Cancer, Breast Carcinoma, DCIS
- Being tested
- Radiation: Accelerated Partial Breast Irradiation (APBI)
- 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.
Radiation: Accelerated Partial Breast Irradiation (APBI)Radiation
Radiation: Accelerated Partial Breast Irradiation (APBI) - 5 fractions delivered every other day before surgery.
Procedure: Surgery - lumpectomy or mastectomy scheduled 1-3 weeks after RT; additional whole-breast/lymph node RT if indicated.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Partial Breast Irradiation | Experimental | Patients will receive 5 fractions of accelerated partial breast irradiation (APBI) delivered before surgery. Surgery is scheduled 1-3 weeks after radiation. If surgical pathology indicates, additional whole-breast or lymph node radiation may be given postoperatively (3-8 weeks after surgery). Receives: Radiation: Radiation: Accelerated Partial Breast Irradiation (APBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility of preoperative APBI
Evaluate the rate of surgical wound complications (infection, delayed healing, dehiscence) following preoperative accelerated partial breast irradiation (APBI).
Measured: Up to 30 days after surgery (with continued safety monitoring through 3 years).
Secondary outcomes (1)
Quality of life (QoL)
Patient-reported outcomes from QoL questionnaires about well-being and treatment experience.
Measured: At consultation, and selected follow-up visits up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start2 Sep 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Why it stopped: 10th patient enrolled; interim analysis to be completed by HROC after 3-month follow-up completed for the 10th patient enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisha Ohri, MD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178665
- Sponsor's protocol ID
- 152502
- Status last verified
- Nov 2025
- First submitted
- 10 Sep 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Prospective Trial to Assess the Feasibility of Preoperative Partial Breast Radiation in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07178665
- Acronym / sponsor ID
- 152502
- Conditions
- Early-stage Breast Cancer, Breast Carcinoma, DCIS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: 10th patient enrolled; interim analysis to be completed by HROC after 3-month follow-up completed for the 10th patient enrolled.
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 17 Sep 2025 (actual)
- 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.
The purpose of our study is to assess the feasibility of preoperative partial breast (APBI) radiation in breast cancer patients. The primary outcome is the acute wound complication rate. We also aim to evaluate cosmetic outcomes and late toxicities as secondary objectives. Another goal is to examine the histopathology of tumors before and after radiation to assess the response and other immunologic and/or molecular changes to the tumor and its environment elicited by the radiation treatment. We hope that this will guide future trials that could change practice in specific patient subgroups.
Detailed description
Our primary objective is to demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic and clinically node negative breast cancer or DCIS who are eligible for BCS and treated with pre-operative partial breast irradiation (PBI) at 1 month is no worse than the rates in the current standard of care (6-20%). Our secondary objective is to demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated WBI (around 35% reported poor/fair cosmesis at 3 years, Shaitelman et al.). Tertiary objectives are to measure acute and late radiation-related toxicities, such as radiation dermatitis, telangiectasia, and fibrosis, in this cohort of patients and to measure biologic markers that radiation may influence.
To measure the pre-operative APBI clinical target volume (CTV) and compare it to the post-op APBI CTV volume that would have been contoured as CTV if the partial breast was to be delivered post-operatively.
To measure the incidence of fair/poor patient-reported cosmetic outcomes using the BCTOS cosmetic scale.
To study cancer biology before and after radiation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative Partial Breast Irradiation | Experimental | Radiation: Radiation: Accelerated Partial Breast Irradiation (APBI)Patients will receive 5 fractions of accelerated partial breast irradiation (APBI) delivered before surgery. Surgery is scheduled 1-3 weeks after radiation. If surgical pathology indicates, additional whole-breast or lymph node radiation may be given postoperatively (3-8 weeks after surgery). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer patients with biopsy-proven invasive ductal cancer or DCIS Tumor size ≤ 2cm clinically and radiographically Estrogen-receptor positive (ER+) on biopsy Grade 1 or 2 on biopsy Clinically and radiographically node-negative disease No indication of metastatic disease Age >50 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Negative serum pregnancy test if applicable Willingness to participate in the clinical trial and adhere to the study protocol Ability to understand and consent to the study
Key exclusion criteria (1 listed)
- Indication for neoadjuvant chemotherapy or hormone therapy Tumor size >2cm clinically or radiographically ER- on biopsy G3 invasive cancer or DCIS on biopsy Lobular histology Multicentric/multifocal tumor BRCA+ gene mutation Prior ipsilateral breast or thoracic RT Contraindication for baseline MRI Contraindication for surgery Distant metastatic disease Other synchronous cancer (besides bilateral breast) Contraindication to Radiation therapy (presence of scleroderma or other collagen vascular disease) Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
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 |
|---|---|---|
| Radiation: Accelerated Partial Breast Irradiation (APBI)Radiation: Accelerated Partial Breast Irradiation (APBI) - 5 fractions delivered every other day before surgery. Procedure: Surgery - lumpectomy or mastectomy scheduled 1-3 weeks after RT; additional whole-breast/lymph node RT if indicated. | Radiation | Preoperative Partial Breast Irradiation |
Primary outcome
Safety and feasibility of preoperative APBI
Time frame: Up to 30 days after surgery (with continued safety monitoring through 3 years).
Evaluate the rate of surgical wound complications (infection, delayed healing, dehiscence) following preoperative accelerated partial breast irradiation (APBI).
1 secondary outcome
Quality of life (QoL)
Time frame: At consultation, and selected follow-up visits up to 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiation: Accelerated Partial Breast Irradiation (APBI) in people with Early-stage Breast Cancer and Breast Carcinoma, run by Rutgers, The State University of New Jersey at 10 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 1 inclusion and 1 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: paused, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Safety and feasibility of preoperative APBI (time frame: Up to 30 days after surgery (with continued safety monitoring through 3 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 14 Nov 2025.