Pilot Trial of Preop Partial Radiation in Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2028-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Early-stage Breast Cancer Breast Carcinoma DCIS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Preoperative Partial Breast Irradiation

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).

Group Type EXPERIMENTAL

Radiation: Accelerated Partial Breast Irradiation (APBI)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nisha Ohri, MD

Associate Professor of Radiation Oncology, Rutgers Robert Wood Johnson Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Identifier Type: -

Identifier Source: org_study_id

Pilot Trial of Preop Partial Radiation in Breast Cancer Patients

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Preoperative Partial Breast Irradiation

Radiation: Accelerated Partial Breast Irradiation (APBI)

Interventions

Radiation: Accelerated Partial Breast Irradiation (APBI)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Rutgers, The State University of New Jersey

Responsible Party

Nisha Ohri, MD

Locations

RWJBarnabas Health Clara Maas Medical Center

Trinitas Hospital and Comprehensive Cancer Center

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

RWJBarnabas Health Jersey City Medical Center

Cooperman Barnabas Medical Center

RWJBarnabas Health - Monmouth Medical Center

Jack and Sheryl Morris Cancer Center

RWJBarnabas Health Newark Beth Israel Medical Center

RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset

RWJBarnabas Health - Community Medical Center

Countries

Central Contacts

Nisha Ohri, MD

Christian Misdary

Facility Contacts

Nisha Ohri, MD

Nisha Ohri, MD

Nisha Ohri, MD

Nisha Ohri, MD

Nisha Ohri, MD

Nisha Ohri, MD

Nisha Ohri, MD

Nisha Ohri, MD

Nisha Ohri, MD

Nisha Ohri, MD

Other Identifiers

152502