Pre-Operative Radiation Therapy for Breast Cancer

(SPORT-DS Trial)

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: Michael Yassa

Must not be taking: Hormonal therapy, Chemotherapy

Disqualifiers: BRCA mutation, Tumor >2cm, Others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a single dose of radiation to a low-risk breast tumor before surgery can be effective. The aim is to determine if this approach can better manage the cancer before the surgery planned for three months later. Eligible participants are women aged 65 or older with a small breast tumor confirmed by tests, without cancer spread to nearby lymph nodes.

As an unphased trial, this study provides a unique opportunity to contribute to innovative cancer treatment research.

Will I have to stop taking my current medications?

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

What prior data suggests that this radiation therapy is safe for breast cancer patients?

Research has shown that a single session of radiation therapy before surgery is generally safe and well-tolerated, particularly for low-risk breast cancer. Studies have found that this approach does not cause surgical complications and is feasible, meaning it can be done without major issues. Most importantly, patients in these studies did not experience serious side effects from the treatment. This suggests it could be a good option for those seeking a less invasive treatment before surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pre-operative radiation therapy for breast cancer because it offers a unique timing and approach compared to the standard protocol. Unlike typical treatments that begin with surgery, this method involves administering a single dose of radiation before any surgical procedure, followed by a delay before the surgery itself. This could potentially reduce the size of the tumor, making surgery less invasive and improving outcomes. Additionally, this approach may enhance the body's immune response to the cancer, offering a new angle in the fight against breast cancer.

What evidence suggests that this treatment might be an effective treatment for breast cancer?

Research has shown that a single dose of radiation therapy before surgery offers a promising treatment for low-risk breast cancer. In this trial, participants will receive this single pre-operative radiation therapy followed by delayed surgery. Studies have found this method to be safe and effective, particularly for older patients with early-stage cancer. This treatment typically results in few surgical complications and is generally manageable for patients. It also effectively targets cancer cells in the breast. Early results suggest it could serve as a good alternative to the usual post-surgery radiation method. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women aged 65 or older with low-risk breast cancer. Eligible participants have a small tumor (less than 2cm), no nodal disease, positive estrogen receptor status, negative Her2, and are planning partial mastectomy. Exclusions include prior cancers (except certain skin cancers), large tumors, lobular carcinoma only, positive lymph nodes, and serious non-cancer illnesses.

Inclusion Criteria

You have had markers placed at the treatment site before starting the trial.

My breast cancer was confirmed by a biopsy within the last 3 months.

My tumor is smaller than 2cm according to a physical exam and ultrasound.

Exclusion Criteria

Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol

I have had cancer before, but if it was skin cancer, it's okay.

I am under 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive a single dose of preoperative partial radiotherapy

1 day

Pre-Surgery Observation

Participants are observed for 3 months before surgery

3 months

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Single Pre-Operative Radiation Therapy - with Delayed Surgery

Trial Overview The study tests a single dose of preoperative partial radiotherapy given three months before surgery on patients with low-risk breast tumors. It aims to assess the effectiveness and safety of this approach compared to traditional treatment timelines.

How Is the Trial Designed?

Group I: Single Pre-Operative Radiation Therapy with Delayed Surgery Experimental Treatment 1 Intervention

Single Pre-Operative Radiation Therapy with Delayed Surgery

Who Is Running the Clinical Trial?

Michael Yassa

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Preoperative radiotherapy for mastocarcinoma can effectively reduce tumor size, allowing for radical surgery, and is preferred over postoperative radiotherapy due to anatomical and radiobiological advantages.

The local control rate of the treatment is impressively high at 90-100%, and the cosmetic outcomes are generally excellent, making it a viable alternative to mastectomy for certain tumor sizes and conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preoperative radiotherapy and curative radiotherapy without mastectomy in carcinoma of the breast (author's transl)]. Sauer, R.[2006]

In a study of 68 patients with Stage III breast cancer, preoperative radiotherapy was found to delay the time until the first local recurrence of cancer, compared to conventional treatment methods.

However, this approach did not lead to an improvement in overall survival rates, suggesting that while it may help manage local disease, it does not enhance control over systemic recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dilemma of stage III breast cancer: a study of preoperative radiotherapy. Whitaker, SV., Battersby, C.[2019]

In a clinical trial involving 250 patients per group, preoperative radiotherapy (RT) significantly reduced the incidence of locally recurrent breast cancer from 16% to 4% without affecting overall survival rates after two years.

The study found that preoperative RT did not increase mortality or metastasis, and the side effects were mild, suggesting that RT is a safe and effective option for reducing local recurrence in operable breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preoperative radiotherapy in breast cancer. Description of a clinical trial record and first results]. de Schryver, A.[2009]

In a study of 1029 breast cancer patients, starting radiation therapy (RT) within 8 weeks after surgery was linked to improved locoregional recurrence-free survival (LRRFS) for those with luminal subtype breast cancer.

No significant differences in disease-free survival (DFS) or overall survival were found based on the timing of RT initiation, suggesting that while early RT may benefit certain patients, it does not universally affect all outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact on clinical outcomes of post-operative radiation therapy delay after neoadjuvant chemotherapy in patients with breast cancer: A multicentric international study. Marta, GN., AlBeesh, R., Pereira, AAL., et al.[2021]

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]

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]

Radiation therapy (RT) is crucial in breast cancer treatment, effectively reducing local recurrence and mortality, with short courses of RT (3-4 weeks) being as effective as longer ones.

Certain patients, particularly older individuals with good prognosis tumors and clear margins, may safely omit radiation boosts, while untreated regional nodes can lead to reduced survival, highlighting the need for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy and early breast cancer: current controversies. Boyages, J.[2019]

Citations

1. 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.

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

Preoperative partial breast radiation for favorable early ... Preoperative PBI is a promising alternative to traditional postoperative radiotherapy for appropriately selected women with early-stage 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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39218041/

Single preoperative radiation therapy with delayed surgery ... Conclusions: Single-fraction preoperative PBI preceding BCS for low-risk breast cancer is feasible, relatively well tolerated and leads to a high level of pR.

5. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-024-02497-4

Advances in breast cancer treatment: a systematic review of ... Preoperative SBRT significantly reduce overall treatment time, enabling to minimalize volumes. Early results indicate excellent cosmetic effects and low ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39218040/

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.

7. redjournal.org redjournal.org/article/S0360-3016(24)03147-X/fulltext

5-Year Results of the Prospective Single-Arm ABLATIVE Trial In conclusion, the ABLATIVE trial has shown that a single ablative dose in preoperative dose PBI is an oncologically safe and feasible treatment ...