Pre-Operative Radiotherapy for Breast Cancer

(SPORT-DNS Trial)

Recruiting at 2 trial locations

Overseen By Michael Yassa

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Maisonneuve-Rosemont Hospital

Must not be taking: Hormonal therapy, Chemotherapy

Disqualifiers: BRCA mutation, Tumor > 2cm, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 1

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a single dose of radiation before surgery can help treat early-stage breast cancer. The goal is to determine if this approach, known as Single Pre-Operative Radiation Therapy, remains effective when surgery occurs a year later. Postmenopausal women with small, hormone-positive breast tumors may be suitable candidates, particularly if they plan to undergo partial breast removal surgery. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options before they become widely available.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants who have had neoadjuvant hormonal manipulation or chemotherapy, which might imply some restrictions on certain treatments.

What prior data suggests that this radiotherapy is safe for preoperative use in breast cancer?

In a previous study, researchers found that a single dose of radiation before surgery is safe and feasible for patients with low-risk, early-stage breast cancer. This treatment did not cause any issues during surgery. Another study demonstrated that this radiation type is manageable for patients and as safe as the usual full breast radiation. Patients reported no serious side effects, indicating it is a safe option. Overall, research shows that single pre-operative radiation therapy is a safe treatment choice for certain breast cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for early breast cancer involve surgery followed by multiple sessions of radiation therapy. However, the single pre-operative radiation therapy being studied is unique because it is delivered before surgery, potentially reducing the need for extensive post-surgical radiation sessions. This method might minimize overall treatment time and reduce side effects, making recovery easier for patients. Researchers are excited because this approach could simplify treatment plans and improve quality of life without compromising the effectiveness of cancer care.

What evidence suggests that Single Pre-Operative Radiation Therapy might be an effective treatment for breast cancer?

Research has shown that a single dose of radiation therapy before surgery effectively treats early-stage breast cancer. In this trial, participants will receive Single Pre-Operative Radiation Therapy. Studies have found that targeting only part of the breast with radiation (partial breast irradiation) is as effective as treating the whole breast for women with low-risk, early-stage breast cancer. This method is also safe, with no reported surgical problems. Additionally, administering radiation before surgery is practical and can be done without major issues. Early results suggest this treatment could be a good option for some breast cancer patients. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for women aged 50 or older with early-stage breast cancer (tumors ≤2cm, ER positive ≥80%, PR positive ≥20%, Her2 negative) who are postmenopausal and have no nodal disease. It's not for those with BRCA mutations, premenopausal women, multiple tumors in one breast, prior cancers within 5 years (except certain skin cancers), or serious non-malignant diseases.

Inclusion Criteria

My scans show a single area of cancer, and these were done within the last 12 weeks.

I am a woman aged 50 or older.

My tumor is 2cm or smaller, confirmed by physical exam and ultrasound.

Exclusion Criteria

I have Paget's disease of the nipple.

You live too far away to come for check-ups and follow-up visits.

You have a breast implant or a pacemaker on the same side as the affected breast.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive neoadjuvant single fraction radiotherapy

1 day

1 visit (in-person)

Surgery

Surgery performed after one year

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Single Pre-Operative Radiation Therapy

Trial Overview The SPORT-DNS trial tests a single pre-operative radiation therapy followed by surgery after one year in eligible women. The aim is to see how effective this approach is compared to traditional methods where surgery occurs sooner after radiation.

How Is the Trial Designed?

Group I: Preoperative radiotherapy for early breast cancer Experimental Treatment 1 Intervention

Radiation: Single Pre-Operative Radiation Therapy

Who Is Running the Clinical Trial?

Maisonneuve-Rosemont Hospital

Lead Sponsor

Trials

102

Recruited

38,300+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Published Research Related to This Trial

This phase I/II clinical trial is investigating the feasibility, safety, and efficacy of preoperative accelerated partial breast irradiation (APBI) in early-stage breast cancer patients, aiming to identify the maximum tolerated dose without severe toxicity.

The study may provide insights into whether preoperative APBI can effectively replace surgery for certain patients, particularly those who are older or have significant health issues, while also exploring its impact on tumor response and local control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fraction ablative preoperative radiation treatment for early-stage breast cancer: the CRYSTAL study - a phase I/II clinical trial protocol. Zerella, MA., Zaffaroni, M., Ronci, G., et al.[2022]

Intense preoperative irradiation using a single focal dose of 6 Gy every other day, totaling 24 Gy over 8-10 days, is as effective as routine dose fractionation and does not complicate surgery or recovery.

This method significantly reduces treatment time and hospital stays, allowing patients to return to work 1.2-2 months earlier compared to traditional methods, while also providing economic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benefits of intensive preoperative irradiation in combined therapy of breast cancer]. Firsova, PP., Kuznetsova, RA.[2006]

The SIGNAL trial demonstrated that single-fraction preoperative radiotherapy (21 Gy) is a feasible and safe approach for treating low-risk breast cancer, with 100% of patients meeting MRI criteria successfully treated after adjusting dosimetric constraints.

At 3 weeks, 6 months, and 1 year post-treatment, there were no significant increases in toxicity, and both patient and physician-rated cosmetic outcomes remained excellent, indicating that this method does not compromise quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic image-guided neoadjuvant ablative single-dose radiation, then lumpectomy, for early breast cancer: the SIGNAL prospective single-arm trial of single-dose radiation therapy. Guidolin, K., Yaremko, B., Lynn, K., et al.[2020]

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]

Large-fractionated preoperative radiation therapy (4 Gy daily for a total of 20 Gy) significantly reduced the preoperative admission period for breast cancer patients compared to standard therapy (2 Gy daily for a total of 40-45 Gy), making treatment more efficient.

Patients receiving large-fractionated radiation therapy experienced lower rates of distant metastasis (32% vs. 51%) and improved 5-year survival rates (65% vs. 45%), particularly benefiting those with local operable tumors (stage III), where survival rates increased from 40% to 64%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative analysis of the effectiveness of standard and large dose fractionation in preoperative breast cancer irradiation]. Aleksandrov, NN., Muravskaia, GV., Pantiushenko, TA., et al.[2007]

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]

Partial breast irradiation (PBI) is becoming a recognized option for early-stage breast cancer treatment, showing similar local control and safety when used pre-operatively compared to traditional post-operative methods.

Pre-operative accelerated PBI (PAPBI) may offer advantages such as a reduced treatment field, increased eligibility for PBI, and improved breast conservation rates, although long-term data is still being developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-operative partial breast irradiation: revolutionizing radiation treatment for women with early stage breast cancer. Li, YR., Barry, PN.[2023]

In a study of 3680 breast cancer patients, surgical intervention was deemed suitable only for stage I cancer, highlighting the need for more aggressive treatment in advanced stages.

Preoperative irradiation, especially in large fractional doses, was identified as the most effective treatment approach for operable tumors, and combining it with UHF-therapy showed promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evolution of radiotherapy of cancer of the breast]. Pavlov, AS., Datsenko, VS.[2006]

Preoperative or neoadjuvant systemic treatment for breast cancer has been shown to provide similar disease-free and overall survival benefits as adjuvant treatment, based on randomized controlled trials.

This approach not only increases the rate of breast-conserving surgeries but also allows for the assessment of how well the primary tumor responds to chemotherapy, highlighting its potential for personalizing treatment based on tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neoadjuvant therapy for operable breast-cancer]. Insa, A., Chirivella, I., Lluch, A.[2019]

In a study of 1325 early-stage breast cancer patients treated with hypofractionated whole-breast radiotherapy, the treatment showed mild acute and late toxicity, with 69.8% experiencing Grade 1 acute toxicity and only 1.7% experiencing Grade 3 toxicity.

The aesthetic outcomes were generally positive, with 70.2% of patients reporting excellent to good results after surgery, and only 3.6% experiencing moderate to marked changes in breast appearance over a median follow-up of 72.4 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity of Hypofractionated Whole Breast Radiotherapy Without Boost and Timescale of Late Skin Responses in a Large Cohort of Early-Stage Breast Cancer Patients. Fodor, A., Brombin, C., Mangili, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12104959/

Preoperative partial breast radiation for favorable early ... Many studies now show comparable efficacy of PBI compared to whole breast irradiation (WBI) for women with low-risk, early-stage breast cancer ...

2. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)03488-1/fulltext

Single pre-operative radiation therapy (SPORT-CK) trial for ... Preoperative single-fraction partial breast irradiation is safe and feasible for elderly patients with low-risk breast cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0167814024034881

Single pre-operative radiation therapy (SPORT-CK) trial for ... Preoperative single-fraction PBI is a safe and feasible treatment for elderly patients with low-risk early-stage breast cancer, with no surgical complications.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4481883/

Preoperative Single-Fraction Partial Breast Radiotherapy Partial breast irradiation (PBI) is increasingly utilized in the treatment of early stage breast cancer. As data supporting the efficacy and tolerability of PBI ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-022-09305-w

Single fraction ablative preoperative radiation treatment for ... The aim of this study is to test the feasibility, safety and efficacy of preoperative radiotherapy (RT) in a single fraction for selected BC patients.

6. redjournal.org redjournal.org/article/S0360-3016(25)00152-X/abstract

Preoperative Single Fraction Stereotactic Partial Breast ... The purpose of this phase 2 clinical study is to investigate the safety and feasibility of a single fraction stereotactic partial breast irradiation (S-PBI) ...