IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

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

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-27

Study Completion Date

2028-02-27

Brief Summary

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

This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study

NCT00595062

Breast Cancer

COMPLETED NA

Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer

NCT04603209

Early-stage Breast Cancer Breast Carcinoma in Situ Breast Neoplasms

RECRUITING

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

NCT05289466

IORT-Intra-Operative Radiation Therapy

TERMINATED NA

IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer

NCT01988870

Breast Cancer

COMPLETED NA

Intra-Operative Radiation Therapy Immediately Following Resection of Early Stage Breast Cancer

NCT02040493

Breast Cancer

TERMINATED NA

Detailed Description

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

Conditions

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

Breast Cancer

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

IORT

All patients will undergo a partial mastectomy with sentinel lymph node biopsy with the goal of achieving a margin-negative resection while maintaining good cosmetic outcome. Immediately following partial mastectomy and frozen section evaluation of the sentinel lymph nodes, IORT is to be delivered. Intraoperative radiation therapy will involve 50 kV xrays to a dose of 20 Gy during breast conserving surgery. After surgery, patients are followed based on the standard schedule determined by their surgeon for 5 years.

IORT

Intervention Type RADIATION

Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

Interventions

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

IORT

Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

Intervention Type RADIATION

Eligibility Criteria

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

Inclusion Criteria

* Female
* ECOG performance status 0-1
* Age 65 years or older
* cT1 or cT2 (≤3.0 cm)
* Invasive ductal carcinoma histology
* Estrogen receptor positive (ER+)
* Grade 1 or Grade 2
* Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
* Suitable for breast conserving surgery and radiation therapy
* Patient must be able to provide study-specific informed consent

Exclusion Criteria

* Multi-centric cancer not amenable to single lumpectomy
* Prior ipsilateral whole breast radiation
* Known BRCA 1 or BRCA 2 mutation
* Status post neoadjuvant hormonal or chemotherapy
* Invasive lobular histology
* Pure ductal carcinoma in situ (DCIS)
* Grade 3
* Diffuse suspicious microcalcifications

Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No