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

20 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. However, it does exclude those who have had neoadjuvant hormonal manipulation or chemotherapy, which might suggest some restrictions on certain treatments.

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

Research suggests that preoperative radiation therapy can reduce the chance of cancer coming back in the same area, as seen in a study where the recurrence rate dropped from 16% to 4% in patients who received radiation before surgery. Additionally, advances in radiation techniques have made it more precise and effective, potentially improving outcomes when used before surgery. ^{1 2 3 4 5}

Is pre-operative radiation therapy for breast cancer safe?

Pre-operative radiation therapy for breast cancer has been studied and is generally considered safe, with modern techniques improving its precision and effectiveness. Advances in technology and understanding of radiation effects have supported its safe use, even in combination with other treatments. ^{2 3 6 7 8}

How is the Single Pre-Operative Radiation Therapy with Delayed Surgery treatment different from other breast cancer treatments?

This treatment is unique because it involves giving radiation therapy before surgery, which is different from the traditional approach where radiation is usually given after surgery. This pre-operative approach aims to shrink the tumor before surgery, potentially allowing for less invasive surgery and improving outcomes. ^{2 3 9 10 11}

What is the purpose of this trial?

To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Mexico pubmed.ncbi.nlm.nih.gov

[Impact of the interval between surgery and radiotherapy in the initial phases of breast cancer in patients who did not receive systemic adjuvant therapy]. [2006]

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

4. Australia pubmed.ncbi.nlm.nih.gov

The dilemma of stage III breast cancer: a study of preoperative radiotherapy. [2019]

5. France pubmed.ncbi.nlm.nih.gov

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

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

The order of administration of chemotherapy and radiation and its effect on the local control of operable breast cancer. [2019]

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

Timing of radiotherapy and chemotherapy following breast-conserving surgery for patients with node-positive breast cancer. International Breast Cancer Study Group. [2019]

8. Japan pubmed.ncbi.nlm.nih.gov

[Histological and biological evaluation of preoperative radiotherapy on T1N0 breast carcinoma]. [2014]

9. Germany pubmed.ncbi.nlm.nih.gov

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

10. Australia pubmed.ncbi.nlm.nih.gov

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

11. Netherlands 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. [2021]