Proton Therapy for Breast Cancer
(COMPRO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Proton Collaborative Group
Disqualifiers: Inflammatory breast cancer, Metastatic disease, Connective tissue disorder, BRCA mutation, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Proton Therapy for Breast Cancer?
Research shows that intensity-modulated proton therapy (IMPT) can reduce radiation exposure to the heart in breast cancer patients, especially those with cancer on the left side. Additionally, studies report positive outcomes for women treated with IMPT after mastectomy, suggesting it may be effective in managing breast cancer while minimizing harm to nearby organs.
12345Is proton therapy generally safe for humans?
Proton therapy, including techniques like intensity-modulated proton therapy (IMPT), has been studied for various cancers, including breast and pancreatic cancer. These studies suggest that proton therapy can reduce radiation exposure to healthy tissues, potentially leading to fewer side effects compared to traditional radiation methods, indicating it is generally safe for humans.
14567How is proton therapy different from other treatments for breast cancer?
Proton therapy for breast cancer is unique because it reduces radiation exposure to the heart and lungs compared to traditional radiation methods, which is especially beneficial for patients with left-sided breast cancer or those requiring internal mammary chain irradiation.
128910Eligibility Criteria
This trial is for women with Stage I-III breast cancer who've had surgery or need postoperative radiation to the breast/chest and lymph nodes. They must have no distant metastases, be in good physical condition (ECOG 0-2), not pregnant, and able to start treatment within 12 weeks of surgery/chemo. Breast reconstruction and bilateral cancer are okay if at least one side gets full nodal irradiation.Inclusion Criteria
I have had a physical exam within the last 90 days.
I have breast implants, expanders, tissue flaps, or other forms of breast reconstruction.
My breast cancer diagnosis is confirmed and requires radiation therapy including to the chest and lymph nodes.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive proton radiation therapy with either a hypofractionated approach over 3 weeks or a standard fractionation over 5 weeks
3-5 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-related skin and soft tissue toxicities
2 years
Long-term Follow-up
Assessment of patient-reported quality of life and physician-reported cosmetic outcomes
10 years
Participant Groups
The study compares two ways of delivering proton radiation therapy: a shorter course over 3 weeks versus a standard longer course over 5 weeks. It aims to understand the effects on women needing radiotherapy after breast cancer surgery.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B - HypofractionationExperimental Treatment1 Intervention
40.05 Gy (RBE) in 15 daily fractions of 2.67 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE)
\*\*Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion\*\*
Group II: Arm A - Standard FractionationActive Control1 Intervention
50-50.4 Gy (RBE) in 25-28 daily fractions of 1.8-2.0 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE)
\*\*Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion\*\*
Proton Therapy is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Proton Therapy for:
- Head and neck cancer
- Pediatric cancers
- Spine tumors
- Breast cancer
- Sarcoma
- Brain tumors
- Prostate cancer
🇪🇺 Approved in European Union as Proton Therapy for:
- Head and neck cancer
- Pediatric cancers
- Spine tumors
- Breast cancer
- Sarcoma
- Brain tumors
- Prostate cancer
🇨🇦 Approved in Canada as Proton Therapy for:
- Head and neck cancer
- Pediatric cancers
- Spine tumors
- Breast cancer
- Sarcoma
- Brain tumors
- Prostate cancer
🇯🇵 Approved in Japan as Proton Therapy for:
- Head and neck cancer
- Pediatric cancers
- Spine tumors
- Breast cancer
- Sarcoma
- Brain tumors
- Prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
New York Proton CenterNew York, NY
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Who Is Running the Clinical Trial?
Proton Collaborative GroupLead Sponsor
References
The Potential Role of Intensity-modulated Proton Therapy in the Regional Nodal Irradiation of Breast Cancer: A Treatment Planning Study. [2020]To investigate the role of intensity-modulated proton therapy (IMPT) for regional nodal irradiation in patients with breast carcinoma in comparison with volumetric-modulated arc therapy (VMAT).
Cardiac substructure exposure in breast radiotherapy: a comparison between intensity modulated proton therapy and volumetric modulated arc therapy. [2022]Proton therapy for breast cancer treatment reduces cardiac radiation exposure. Left-sided breast cancer patients with indication for internal mammary chain (IMC) irradiation are most at risk of radiation-induced cardiotoxicity. This study aims to evaluate in this situation the potential dosimetric benefit of intensity modulated proton therapy (IMPT) over volumetric modulated arc therapy (VMAT) at the cardiac substructure level.
Postmastectomy Intensity Modulated Proton Therapy: 5-Year Oncologic and Patient-Reported Outcomes. [2023]To report oncologic, physician-assessed, and patient-reported outcomes (PROs) for a group of women homogeneously treated with modern, skin-sparing multifield optimized pencil-beam scanning proton (intensity modulated proton therapy [IMPT]) postmastectomy radiation therapy (PMRT).
Proton therapy for the treatment of inflammatory breast cancer. [2022]Inflammatory breast cancer (IBC) poses a radiotherapeutic challenge due to dermal lymphatic involvement, which often necessitates larger target volumes and chest wall boosts, making advanced planning techniques attractive to reduce exposure to nearby organs. We report our experience with intensity modulated proton therapy (IMPT) for the treatment of IBC.
Feasibility study: spot-scanning proton arc therapy (SPArc) for left-sided whole breast radiotherapy. [2021]This study investigated the feasibility and potential clinical benefit of utilizing a new proton treatment technique: Spot-scanning proton arc (SPArc) therapy for left-sided whole breast radiotherapy (WBRT) to further reduce radiation dose to healthy tissue and mitigate the probability of normal tissue complications compared to conventional intensity modulated proton therapy (IMPT).
Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes. [2022]Pencil-beam scanning intensity modulated proton therapy (IMPT) may allow for an improvement in the therapeutic ratio compared with conventional techniques of radiation therapy delivery for pancreatic cancer. The purpose of this study was to describe the clinical implementation of IMPT for intact and clinically localized pancreatic cancer, perform a matched dosimetric comparison with volumetric modulated arc therapy (VMAT), and report acute adverse event (AE) rates and patient-reported outcomes (PROs) of health-related quality of life.
Postoperative proton radiotherapy for localized and locoregional breast cancer: potential for clinically relevant improvements? [2022]To study the potential reduction of dose to organs at risk (OARs) with intensity-modulated proton radiotherapy (IMPT) compared with intensity-modulated radiotherapy (IMRT) and three-dimensional conformal radiotherapy (3D-CRT) photon radiotherapy for left-sided breast cancer patients.
Techniques for Treating Bilateral Breast Cancer Patients Using Pencil Beam Scanning Technology. [2022]Patients with bilateral breast cancer (BBC), who require postmastectomy radiation therapy or radiation as part of breast conservation treatment, present a unique technical challenge. Even with modern techniques, such as intensity modulated radiation therapy or volumetric modulated arc therapy (VMAT), adequate target coverage is rarely achieved without the expense of increased integral dose to important organs at risk (OARs), such as the heart and lungs. Therefore, we present several BBC techniques and a treatment algorithm using intensity-modulated proton therapy (IMPT) for patients treated at our center.
Intensity modulated proton therapy for postmastectomy radiation of bilateral implant reconstructed breasts: a treatment planning study. [2013]Delivery of post-mastectomy radiation (PMRT) in women with bilateral implants represents a technical challenge, particularly when attempting to cover regional lymph nodes. Intensity modulated proton therapy (IMPT) holds the potential to improve dose delivery and spare non-target tissues. The purpose of this study was to compare IMPT to three-dimensional (3D) conformal radiation following bilateral mastectomy and reconstruction.
Proton pencil beam scanning reduces secondary cancer risk in breast cancer patients with internal mammary chain involvement compared to photon radiotherapy. [2021]Proton pencil beam scanning (PBS) represents an interesting option for the treatment of breast cancer (BC) patients with nodal involvement. Here we compare tangential 3D-CRT and VMAT to PBS proton therapy (PT) in terms of secondary cancer risk (SCR) for the lungs and for contralateral breast.