Radiation Therapy for Early-Stage Breast Cancer

Overseen By Eric A. Strom, BS,MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Men, Cognitive impairment, Advanced cancer, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of radiation therapy for women with early-stage breast cancer, specifically stages 0, I, or II. It focuses on a specialized type of radiation that directly targets the tumor, aiming to kill more cancer cells while minimizing harm to healthy tissue. Women who have had a lumpectomy and have a single breast tumor no larger than 3 cm might be suitable candidates. The trial aims to determine if this approach can be an effective treatment with fewer side effects. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that proton beam therapy, a type of radiation treatment, is generally manageable for patients with early-stage breast cancer. In a study with 1,452 patients, those who received proton beam therapy experienced positive outcomes over a follow-up period of 2 to 59 months. Another large study found that patients often preferred proton therapy over traditional photon therapy due to the excellent results.

Additionally, a Mayo Clinic study suggested that proton beam therapy can shorten treatment time for breast cancer patients, potentially reducing side effects. The two-year local progression-free survival rate, indicating the percentage of patients whose cancer did not worsen, was very high at 94.8% for those treated with proton beam therapy.

While every treatment can have side effects, these findings suggest that proton beam therapy is a promising and safe option for many patients with early-stage breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for early-stage breast cancer, which typically involves whole-breast radiation therapy, the new approach uses Accelerated Partial Breast Irradiation (APBI) with proton radiation. This method is unique because it delivers targeted radiation directly to the tumor site twice a day for just five days, significantly reducing treatment time. Researchers are excited about this treatment because it aims to minimize radiation exposure to healthy tissue, potentially leading to fewer side effects and a quicker recovery for patients.

What evidence suggests that this trial's treatments could be effective for early-stage breast cancer?

Research has shown that proton beam therapy, which participants in this trial may receive, can be very effective for early-stage breast cancer. A large study found that patients achieved excellent results with this treatment. Proton therapy targets high doses of radiation directly at the tumor, killing more cancer cells while protecting healthy tissue. Studies also found that this therapy can control cancer effectively and may reduce overall treatment time compared to traditional methods. This makes proton beam therapy a promising option for treating early-stage breast cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Eric A. Strom

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women over 18 with stage 0-II breast cancer, where the tumor is no larger than 3 cm and located in one area. They must have had a lumpectomy with clear margins and be at low risk of recurrence if they've had non-breast cancers before. Men, pregnant or breastfeeding women, those with advanced cancer stages or certain other conditions are excluded.

Inclusion Criteria

I have been cancer-free from a non-breast cancer for over 5 years and considered low risk for its return.

I am a woman who has agreed to participate and signed the consent form.

My breast cancer is in an early stage and, if stage II, my tumor is 3 cm or less.

Exclusion Criteria

My breast cancer is at an advanced stage (larger than 3 cm, or stage III/IV).

I have more than 3 lymph nodes in my armpit area affected by cancer.

You have suspicious small calcium deposits or abnormal tissue unless it has been checked and confirmed to be harmless through a biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo accelerated partial breast irradiation (APBI) delivered with proton radiation twice daily for 5 days

1 week

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Visits at 6 weeks, 6 months, 1 year, 18 months, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Proton Beam Radiation Therapy
• Radiation Therapy

Trial Overview The study tests high-dose radiation therapy aimed directly at the tumor to see if it's more effective and less harmful to healthy tissue. It involves Accelerated Partial Breast Irradiation (APBI) using Proton Beam Radiation Therapy while also assessing patients' quality of life.

How Is the Trial Designed?

Group I: Treatment (APBI) Experimental Treatment 3 Interventions

Within 10 weeks of last breast cancer surgery, patients undergo APBI delivered with proton radiation BID for 5 days.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Adjuvant radiotherapy is crucial for reducing local recurrences in early breast cancer, with moderate hypofractionated whole-breast irradiation being the standard treatment.

Recent advancements in irradiation techniques allow for shorter and more personalized treatment plans, making therapy more tolerable and potentially leading to de-escalation of treatment intensity based on individual patient risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adjuvant radiation therapy for breast cancer]. Lange, T., Knöchelmann, AC., Bremer, M.[2023]

In a study of 260 men with localized prostate cancer treated with high-dose IGRT and IMRT, the combination resulted in a low rate of late toxicity, with only 4.4% experiencing grade 2 gastrointestinal issues and 7.1% with grade 2 genitourinary issues after 7 years.

The treatment showed high efficacy, with a 7-year prostate-specific antigen relapse-free survival rate of 97.1% for low-risk patients, indicating that this approach is both safe and effective for managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Results of IGRT in Prostate Cancer Treatment. Doležel, M., Odrážka, K., Vaňásek, J., et al.[2021]

In a study of 100 prostate cancer patients treated with high-dose intensity-modulated radiotherapy (IMRT) and image-guided treatment (IGRT), acute gastrointestinal (GI) toxicity was observed in 12% and genitourinary (GU) toxicity in 42%, with only 4% experiencing severe GU toxicity (grade 3).

After a median follow-up of 26 months, late toxicity rates were low, with only 1.5% experiencing late GI toxicity and 7.7% experiencing late GU toxicity, indicating that high-dose radiotherapy is both effective and has manageable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. Guckenberger, M., Ok, S., Polat, B., et al.[2022]

In a study of 421 patients undergoing salvage radiotherapy (SRT) after prostate surgery, the use of advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) significantly reduced the incidence of late gastrointestinal (GI) toxicities to 4.8%.

However, increasing the radiation dose to 68 Gy or more was linked to a higher risk of genitourinary (GU) toxicities, indicating that while advanced techniques can help minimize some side effects, higher doses may still pose risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. Tomita, N., Uchiyama, K., Mizuno, T., et al.[2021]

Intraoperative radiotherapy (IORT) for early-stage breast cancer significantly improves radiation-related quality of life (QoL) parameters, with patients reporting less pain and better functioning compared to those receiving external beam radiotherapy (EBRT).

In a study of 230 women, those treated with IORT alone experienced fewer breast and arm symptoms and better overall role functioning, indicating that IORT may be a more patient-friendly option than traditional EBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. Welzel, G., Boch, A., Sperk, E., et al.[2021]

In a study of 658 patients with high-risk endometrial cancer, intensity-modulated radiation therapy (IMRT) was associated with significantly fewer grade ≥2 adverse events, such as diarrhea and hematologic issues, compared to 3-dimensional conformal radiation therapy (3DCRT) during follow-up.

IMRT also showed a trend towards fewer patient-reported symptoms like bowel urgency and abdominal cramps during treatment, indicating it may provide a better quality of life for patients undergoing radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy. Wortman, BG., Post, CCB., Powell, ME., et al.[2022]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7615202/

Proton Beam Therapy for Early Breast Cancer - PubMed Central Thirty-two studies (1452 patients) reported clinical outcomes after adjuvant PBT for early breast cancer. Median follow up ranged from 2-59 ...

2. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/first-randomized-study-comparing-proton-and-photon-radiation-therapy-for-breast-cancer-finds-both-pr

First randomized study comparing proton and photon ... Large phase III trial shows patients report excellent outcomes after either treatment, with differences in preference favoring protons.

3. newsnetwork.mayoclinic.org newsnetwork.mayoclinic.org/discussion/new-mayo-clinic-study-reveals-proton-beam-therapy-may-shorten-breast-cancer-treatment/

Mayo Clinic study reveals proton beam therapy may ... The investigators found that both conventional and hypofractionated proton therapy resulted in excellent control of the cancer while sparing ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01766297

Phase II Protocol of Proton Therapy for Partial Breast ... This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10894553/

Proton Therapy in Breast Cancer: A Review of Potential ... Outcomes of proton therapy on breast cancer patients. 46% (19/41) acute G ≥ 2 RD in the conventional fractionation group and 17% (7/41) in the ...

6. guidelines.carelonmedicalbenefitsmanagement.com guidelines.carelonmedicalbenefitsmanagement.com/proton-beam-therapy-2025-03-23/

Proton Beam Therapy 2025-03-23 - Carelon Clinical Guidelines For the patients treated per protocol, the two-year local progression-free survival rate was 94.8% in the PBT patients vs 83.9% for RFA (P < .001). The authors ...