Proton Therapy for Early Stage Breast Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2020-05-12

Brief Summary

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

The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.

Related Clinical Trials

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

Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer

NCT01245712

Breast Adenocarcinoma Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma +7 more

ACTIVE_NOT_RECRUITING PHASE2

Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

NCT01340495

Invasive Breast Cancer

UNKNOWN NA

Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer

NCT00527293

Breast Cancer

COMPLETED EARLY_PHASE1

Phase III Study of 5tx vs 15tx of RT (X-rays or Protons) Including RNI in Breast Cancer Patients

NCT04443413

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8

ACTIVE_NOT_RECRUITING PHASE3

Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy

NCT07135661

Breast Cancer Proton Therapy

RECRUITING NA

Detailed Description

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

Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.

Conditions

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

Early-Stage Breast Cancer

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.

Proton Radiotherapy

Two week course of proton radiotherapy to the breast.

Group Type EXPERIMENTAL

Proton radiation therapy

Intervention Type RADIATION

Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.

Interventions

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

Proton radiation therapy

Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.

Intervention Type RADIATION

Eligibility Criteria

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

Inclusion Criteria

* Invasive ductal, medullary, papillary, colloid or tubular histologies
* Stages T1 or T2 (tumors \< or = 3 cm) from lumpectomy specimen.
* No more then 3 positive nodes on axillary dissection or negative sentinel node.
* Negative surgical margins (\>2mm)

Exclusion Criteria

* Invasive lobular histology
* Previous chemotherapy for breast cancer
* Extensive intraductal component
* Collagen vascular disease
* Prior malignancy unless disease-free for 5 years
* Patients who are pregnant or lactating

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No