Pre-Surgery Radiation Therapy for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Breast-feeding, Radiotherapy contraindication

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: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether administering radiation therapy before surgery can shrink hormone receptor-positive, HER2-negative breast cancer tumors. The aim is to reduce tumor size, potentially allowing surgeons to preserve more healthy tissue during surgery. Patients will receive radiation treatment a few days before surgery and then continue with regular care afterward. Suitable candidates have a specific type of breast cancer that is at least 1 cm in size and have already had a clip placed in the tumor. As a Phase 2 trial, the research focuses on measuring 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 administering radiation therapy before breast cancer surgery is generally safe and well-tolerated, particularly for certain groups. For instance, one study found this approach safe and feasible for elderly patients with early-stage breast cancer, suggesting it could be safe for a broader range of patients.

Radiation therapy can sometimes cause side effects like skin irritation or tiredness, but these are usually temporary and manageable. The treatment aims to shrink tumors before surgery, potentially allowing for less tissue removal, which can aid recovery and improve overall outcomes.

While individual experiences may vary, existing research indicates that pre-surgery radiation therapy is a promising and safe option for treating breast cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about this treatment because it involves using boost radiation therapy just days before breast surgery, which is a unique approach compared to the usual post-surgery radiation. This pre-surgical radiation could potentially shrink tumors more effectively, making surgery easier and possibly more successful. Additionally, this method aims to reduce the overall exposure to radiation by streamlining the treatment process, which could lead to fewer side effects for patients. This proactive approach could revolutionize how we think about timing in cancer treatment.

What evidence suggests that radiation therapy before surgery might be an effective treatment for breast cancer?

Research has shown that administering radiation therapy before surgery can effectively treat early-stage breast cancer. In this trial, participants will receive boost radiation therapy 6-8 days before breast surgery. Studies have found that this method can extend the time patients live without cancer recurrence. It can also shrink tumors, potentially reducing the amount of tissue removed during surgery. Many studies indicate that using radiation before surgery is as effective as the traditional method of treating the whole breast with radiation for patients with low-risk, early-stage breast cancer. Overall, these findings suggest that pre-surgery radiation therapy could be a promising option for patients with hormone receptor-positive, HER2-negative breast cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Simona F. Shaitelman

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with hormone receptor positive, HER2 negative breast cancer who are fit enough for treatment (ECOG 0-1). They must have a tumor that can be biopsied and measured on ultrasound, agree to see multiple specialists, and not be pregnant or breastfeeding. A clip should already be in place in the primary breast cancer.

Inclusion Criteria

Signed written informed consent

I am fully active or can carry out light work.

My breast cancer is HR+ and HER2- as confirmed by tests.

Exclusion Criteria

I am not pregnant or breast-feeding.

I cannot undergo radiotherapy due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Radiation

Participants undergo boost radiation therapy 6-8 days before breast surgery

1-2 weeks

1 visit (in-person)

Surgery

Participants undergo breast surgery following preoperative radiation

1 day

1 visit (in-person)

Adjuvant Radiation Therapy

Participants continue to receive standard of care radiation therapy after surgery

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Radiation Therapy
• Therapeutic Conventional Surgery

Trial Overview The study is testing if giving radiation therapy before surgery can shrink tumors effectively in patients with specific types of breast cancer. The goal is to potentially reduce the amount of healthy tissue removed during surgery.

How Is the Trial Designed?

Group I: Treatment (radiation therapy, surgery) Experimental Treatment 2 Interventions

Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.

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

Recent advancements in breast cancer treatment are shifting towards administering systemic therapy before surgery, which can lead to more effective treatment outcomes and potentially higher rates of disease-free and overall survival.

The evolving approach to radiotherapy includes considering its use before surgery, supported by improved radiobiological knowledge and technology, allowing for safer and more effective combinations with other treatments like antitumor drugs or immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Radio(Chemo)Therapy in Breast Cancer: Time to Switch the Perspective? Montero, A., Ciérvide, R.[2023]

In a study of 192 patients with localized prostate cancer, using prostate-based IGRT (P-IGRT) resulted in significantly lower acute gastrointestinal toxicities compared to bony structure-based IGRT (B-IGRT), with rates of 3% versus 11%.

Both P-IGRT and B-IGRT showed similar prostate-specific antigen failure-free survival rates at 3 years (95.5% for P-IGRT and 92.7% for B-IGRT), indicating that P-IGRT can reduce toxicity without compromising tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. Nakamura, K., Mizowaki, T., Inokuchi, H., et al.[2018]

In a study of 836 prostate cancer patients, those who received image-guided radiotherapy (IGRT) had a 5-year overall survival rate of 88%, which was not significantly different from the 86% survival rate of patients who did not receive IGRT, indicating that IGRT does not negatively impact survival outcomes.

The study found no significant differences in mortality rates from prostate cancer, other cancers, or cardiovascular issues between the IGRT and non-IGRT groups, suggesting that IGRT is a safe option for localized prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of image-guided radiotherapy in definitive radiotherapy for localized prostate cancer: a population-based analysis. Kuo, YH., Liang, JA., Chen, GH., et al.[2022]

Recent interest in preoperative breast radiation therapy (RT) is growing due to advancements in modern techniques, which may improve its effectiveness compared to older studies that did not change clinical practice.

Current clinical trials are exploring the combination of preoperative RT with novel drugs, aiming to enhance treatment outcomes and optimize translational research in breast cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative breast radiation therapy: Indications and perspectives. Lightowlers, SV., Boersma, LJ., Fourquet, A., et al.[2021]

In a study of 82 patients with early-stage breast cancer treated with intraoperative radiotherapy (IORT), 72% of those who underwent 21-gene recurrence testing were classified as low risk, indicating that IORT may be suitable for a majority of these patients.

The study highlights a need for further research on the long-term clinical outcomes and safety of IORT, as most patients selected for this treatment were low risk based on their recurrence scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

21-gene recurrence assay in patients receiving intraoperative radiotherapy: are "favorable" characteristics a surrogate for low recurrence? Oppong, BA., Sen Gupta, S., Gary, M., 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]

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]

Intraoperative radiotherapy (IORT) was used in a study involving 1367 patients with 1400 tumors, showing a 5-year local recurrence rate of 5.98% for those receiving IORT only, which is comparable to other IORT studies but higher than standard whole breast radiation therapy (WBRT).

IORT offers benefits such as convenience and low complication rates, making it a viable option for patients meeting specific criteria, although the addition of WBRT was found to significantly reduce the risk of local recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). Silverstein, MJ., Epstein, MS., Chen, P., et al.[2022]

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]

Radiation therapy is crucial in breast cancer treatment, significantly reducing local recurrence and improving survival rates, especially with advancements in techniques since the late 1980s.

Shorter courses of radiation therapy (3-4 weeks) are generally as effective as longer ones, and modern techniques like volumetric modulated arc therapy (VMAT) help minimize complications while enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of radiotherapy techniques in breast conservation treatment. Boyages, J., Baker, L.[2020]

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]

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]

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