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Proton Radiation for Stage II/III Breast Cancer

Primary Purpose

Breast Cancer, Breast Neoplasm, Breast Tumor

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Proton Radiotherapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast, Cancer, Radiation, Proton

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
Must be > = 18 years of age.
Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular
Must meet stage II - III group criteria per AJCC Staging manual 7th edition.
Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted.
Note: Multicentric breast cancer and Paget's disease of the nipple are permitted.

Exclusion Criteria:

Weight over 410 pounds.
Non-epithelial breast malignancies such as sarcoma or lymphoma.
Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible).
Breast size exceeding the technical limitation of daily set-up reproducibility. This may be center-specific and will be assessed at the discretion of the treating center.
Women with post-surgical temporary breast expanders will require individual assessment. Depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator.
Prior history of breast cancer.
Prior radiation to the breast or thorax.
Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (Note: Women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration).
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. Further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.

Sites / Locations

Northwestern Medicine Chicago Proton Center
Maryland Proton Treatment Center
Princeton ProCure Managment LLC
Oklahoma Proton Center
Hampton University Proton Therapy Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Radiotherapy

Arm Description

Proton Radiotherapy

Outcomes

Primary Outcome Measures

Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment.

Secondary Outcome Measures

Compare dosimetrically the dose volume histogram (DVH) of the PT plans with conventional external beam plans (either photon/electron intensity modulated radiotherapy(IMRT)plans, 3D-photon plans, or Tomotherapy plans).

Incidence rates of local control, regional control, metastatic status and disease free overall survival.

Compare the different DVH parameters for the targets (D2, Dmean, Dmin, D95, V95, V110) and different OARs (as described later) of the PT plans with the corresponding values of the 3D-conformal radiation therapy (CRT), IMRT and Tomotherapy plans.

Determine dose distribution of proton therapy to coronary arteries, heart, ipsilateral and contralateral lung, and contralateral breast.

Determine the incidence of clinically symptomatic coronary artery disease, cardiac morbidity and mortality in general and incidence of secondary malignancy, including contralateral breast cancer

Evaluate quality of life results.

Full Information

NCT ID

NCT01758445

First Posted

December 14, 2012

Last Updated

April 1, 2023

Sponsor

Proton Collaborative Group

1. Study Identification

Unique Protocol Identification Number

NCT01758445

Brief Title

Proton Radiation for Stage II/III Breast Cancer

Official Title

Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Patients With Stage II/III,Loco-Regional, Non-Metastatic Breast Cancer Requiring Whole Breast or Chest Wall Irradiation With Lymph Node Irradiation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 2013 (undefined)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Proton Collaborative Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to look at the rates of acute and long term adverse events of postoperative proton radiotherapy for complex loco-regional irradiation in women with loco-regionally advanced breast cancer. This study specifically includes longitudinal follow up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15 years following proton therapy(PT).

Detailed Description

The proposed Phase II study is seeking to build clinical data as a continuation of the original dosimetric analysis published by Ares et al. performed at Paul-Scherrer Institute (PSI). That comparison demonstrated a benefit form proton planning for patients with non-metastatic breast cancer requiring complex, loco-regional, postoperative radiotherapy.1 The advantages of PT were improved target coverage compared to standard photon irradiation and reduced dose to heart, lungs and contralateral breast. The study goal is to demonstrate a "meaningful benefit" of proton therapy for women with loco-regionally advanced breast cancer. The main clinical endpoints of this trial are the reduction of cardiac morbidity and mortality (coronary artery disease, myocardial infarction, cardiac insufficiency) and the reduction of contralateral, second breast cancer. Both adverse events are presently associated with external beam photon therapy. Both goals require longitudinal follow-up of minimum 5-10 years. Despite the logistical challenges of long term follow-up, the effort is needed in view of the compelling preclinical evidence of dose avoidance or even absence of radiation dose to heart and contralateral breast uniquely accomplishable by protons only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Breast Neoplasm, Breast Tumor, Cancer of the Breast

Keywords

Breast, Cancer, Radiation, Proton

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proton Radiotherapy

Arm Type

Experimental

Arm Description

Proton Radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Proton Radiotherapy

Intervention Description

Radiation therapy will be given once a day. Minimum of 28 treatments and may receive 6-9 additional treatments as determined by protocol & physician.

Primary Outcome Measure Information:

Title

Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Time Frame

On average at 9 weeks post start of treatment

Title

Incidence rates of local control, regional control, metastatic status and disease free overall survival.

Time Frame

5 years

Title

Time Frame

On average at 9 weeks post start of treatment

Title

Determine dose distribution of proton therapy to coronary arteries, heart, ipsilateral and contralateral lung, and contralateral breast.

Time Frame

On average at 9 weeks post start of treatment

Title

Determine the incidence of clinically symptomatic coronary artery disease, cardiac morbidity and mortality in general and incidence of secondary malignancy, including contralateral breast cancer

Time Frame

5 years

Title

Evaluate quality of life results.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial. Must be > = 18 years of age. Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer. Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular Must meet stage II - III group criteria per AJCC Staging manual 7th edition. Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted. Note: Multicentric breast cancer and Paget's disease of the nipple are permitted. Exclusion Criteria: Weight over 410 pounds. Non-epithelial breast malignancies such as sarcoma or lymphoma. Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible). Breast size exceeding the technical limitation of daily set-up reproducibility. This may be center-specific and will be assessed at the discretion of the treating center. Women with post-surgical temporary breast expanders will require individual assessment. Depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator. Prior history of breast cancer. Prior radiation to the breast or thorax. Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (Note: Women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration). Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements. Prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. Further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eugen Hug, MD

Organizational Affiliation

Proton Collaborative Group

Official's Role

Study Chair

Facility Information:

Facility Name

Northwestern Medicine Chicago Proton Center

City

Warrenville

State/Province

Illinois

ZIP/Postal Code

60555

Country

United States

Facility Name

Maryland Proton Treatment Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Princeton ProCure Managment LLC

City

Somerset

State/Province

New Jersey

ZIP/Postal Code

08873

Country

United States

Facility Name

Oklahoma Proton Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73142

Country

United States

Facility Name

Hampton University Proton Therapy Institute

City

Hampton

State/Province

Virginia

ZIP/Postal Code

23666

Country

United States

12. IPD Sharing Statement

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Proton Radiation for Stage II/III Breast Cancer

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