Pre-Operative Radiotherapy for Breast Cancer

(SPORT-DNS Trial)

Recruiting at 1 trial location

Overseen By Michael Yassa

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Maisonneuve-Rosemont Hospital

Must not be taking: Hormonal therapy, Chemotherapy

Disqualifiers: BRCA mutation, Tumor > 2cm, others

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial involves women receiving a single treatment to shrink the tumor before surgery, which will take place after some time.

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 data supports the effectiveness of the treatment Single Pre-Operative Radiation Therapy for breast cancer?

Research shows that preoperative radiation therapy can be effective in reducing the time needed for treatment and hospital stays, without increasing complications. It also suggests that using larger doses in fewer sessions may improve survival rates and reduce the chance of cancer spreading. ^{1 2 3 4 5}

Is pre-operative radiotherapy for breast cancer safe?

Early studies suggest that pre-operative partial breast irradiation (radiation treatment) can be safely used for early-stage breast cancer, with similar local control and no increased side effects compared to traditional methods. However, long-term safety data is still being collected. ^{1 4 6 7 8}

How is Single Pre-Operative Radiation Therapy different from other breast cancer treatments?

Single Pre-Operative Radiation Therapy is unique because it involves giving a high dose of radiation in one session before surgery, which can help shrink the tumor and potentially allow for more conservative surgery. This approach is different from the traditional method where radiation is given after surgery over several weeks. ^{1 3 4 9 10}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Single Pre-Operative Radiation Therapy (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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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 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]

References

1. England 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. [2022]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Benefits of intensive preoperative irradiation in combined therapy of breast cancer]. [2006]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Preoperative Radio(Chemo)Therapy in Breast Cancer: Time to Switch the Perspective? [2023]

4. England pubmed.ncbi.nlm.nih.gov

Preoperative breast radiation therapy: Indications and perspectives. [2021]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Comparative analysis of the effectiveness of standard and large dose fractionation in preoperative breast cancer irradiation]. [2007]

6. China pubmed.ncbi.nlm.nih.gov

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

7. United States 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. [2022]

8. Switzerland 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. [2020]

9. Spain pubmed.ncbi.nlm.nih.gov

[Neoadjuvant therapy for operable breast-cancer]. [2019]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Evolution of radiotherapy of cancer of the breast]. [2006]