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

200 Participants Needed

Trial Summary

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 this treatment for early-stage breast cancer?

Research shows that radiation therapy, including advanced techniques like intraoperative radiotherapy (IORT) and intensity-modulated radiation therapy (IMRT), helps reduce the chance of cancer returning in early-stage breast cancer. These methods aim to minimize side effects and improve the quality of life by targeting the cancer more precisely and reducing treatment time. ^{1 2 3 4 5}

Is radiation therapy generally safe for humans?

Radiation therapy techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) have been studied for safety in various conditions, including prostate and endometrial cancer. These studies show that while there can be some side effects, such as gastrointestinal and genitourinary issues, advanced techniques like IMRT and IGRT help reduce these risks by better targeting the treatment area and sparing normal tissues. ^{6 7 8 9 10}

How is radiation therapy unique for treating early-stage breast cancer?

Radiation therapy for early-stage breast cancer is unique because it can be tailored to the patient's risk profile, allowing for shorter and more individualized treatments. Techniques like hypofractionation and intensity-modulated radiation therapy (IMRT) help minimize side effects by targeting the cancer more precisely, and options like intraoperative radiotherapy offer innovative ways to deliver treatment during surgery. ^{1 2 4 11 12}

What is the purpose of this trial?

This phase II trial studies the side effects and how well radiation therapy works in treating patients with stage 0-II breast cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

Research Team

Eric A. Strom

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Adjuvant radiation therapy for breast cancer]. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Applying innovations in surgical and radiation oncology to breast conservation therapy. [2018]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Radiation options for early stage breast cancer. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A prospective phase I comparison of toxicity and cosmesis outcomes of single-fraction IORT and hypofractionated radiotherapy with IORT boost in early-stage breast cancer. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]

9. Czech Republic pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Results of IGRT in Prostate Cancer Treatment. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Radiotherapy in the management of early breast cancer. [2018]

12. Hungary pubmed.ncbi.nlm.nih.gov

[Radiotherapy of early breast cancer. More than loco-regional tumor control] [2019]