What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as radiation therapy, tamoxifen, and aromatase inhibitors, have various side effects. Radiation therapy can cause skin irritation, fatigue, breast pain, and in some cases, more severe effects like pneumonitis or heart problems. Tamoxifen, a selective estrogen receptor modulator, may lead to hot flashes, vaginal dryness, and an increased risk of blood clots and endometrial cancer. Aromatase inhibitors, used in postmenopausal women, can result in bone density loss, fractures, and cardiovascular issues. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that involve radiotherapy, which uses high-energy radiation to damage the DNA of cancer cells. One such approach is external beam radiation therapy (EBRT), which is commonly used post-surgery to eliminate residual cancer cells. Additionally, drugs like trastuzumab (Herceptin) and pertuzumab (Perjeta) are often used in combination with radiotherapy for HER2-positive breast cancer, enhancing the treatment's effectiveness. These therapies aim to reduce recurrence and improve survival rates by targeting and destroying cancerous cells.

What other types of research exist?

Promising novel alternatives to Single Fraction Radiotherapy for breast cancer patients include: 1) Accelerated Partial Breast Irradiation (APBI) using brachytherapy or 3D conformal radiotherapy, which targets only the tumor bed and spares healthy tissue. 2) Intensity-Modulated Radiotherapy (IMRT), which allows precise targeting of the tumor while minimizing exposure to surrounding healthy tissue. 3) Proton Therapy, which uses protons instead of X-rays for more precise radiation delivery with potentially fewer side effects. 4) Investigational therapies such as ONC201, which is under active investigation for its potential efficacy in specific cancer mutations.

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Radiation Therapy

Pre-Operative Radiotherapy for Breast Cancer (SPORT-DNS Trial)

N/A

Recruiting

Research Sponsored by Maisonneuve-Rosemont Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned surgery is a partial mastectomy with sentinel lymph node biopsy

Female aged 50 years or older

Must not have

Paget's disease of the nipple

Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the radiation may include skin changes like redness and irritation at the treatment site, fatigue, swelling in the treated area (lymphedema), and rarely more serious complications such as heart or lung issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a partial breast removal and sentinel lymph node biopsy.

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I am a woman aged 50 or older.

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

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My cancer has a low risk of coming back according to the Oncotype DX test.

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I am postmenopausal based on age, surgery, or not having periods for over a year.

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My biopsy shows I am progesterone receptor positive.

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My biopsy shows I am HER2 negative.

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My biopsy shows my cancer is mostly estrogen receptor positive.

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I can perform daily activities with little to no assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have Paget's disease of the nipple.

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I do not have a serious illness like heart or lung disease that would prevent me from receiving radiation therapy.

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I have had breast cancer before.

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I have had radiation therapy on the same side breast before.

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My tumor is larger than 2 cm according to an ultrasound.

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My cancer is specifically lobular carcinoma.

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I have a harmful BRCA1 or BRCA2 gene mutation.

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I am under 50 years old.

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My biopsy shows I have a non-invasive type of breast cancer.

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I have multiple tumors in different areas of the same breast.

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I have had skin cancer other than basal or squamous cell in the last 5 years.

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My underarm lymph nodes are affected by cancer.

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My estrogen receptor status is unknown.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: Preoperative radiotherapy for early breast cancerExperimental Treatment1 Intervention

Radiation: Single Pre-Operative Radiation Therapy

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes the tumor, while radiation therapy, such as single fraction radiotherapy, uses high-energy radiation to damage the DNA of cancer cells, preventing them from growing and dividing. Chemotherapy involves drugs that kill rapidly dividing cells, including cancer cells. Endocrine therapy blocks hormones like estrogen that can promote cancer growth in hormone receptor-positive breast cancer. Targeted therapies, such as HER2 inhibitors, specifically target molecular markers on cancer cells to inhibit their growth. These treatments are crucial for breast cancer patients as they offer multiple strategies to control and potentially eradicate the disease, improving survival rates and quality of life.

Abbreviated course of radiotherapy (RT) for breast cancer.

Find a Location

Who is running the clinical trial?

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

461 Previous Clinical Trials

164,273 Total Patients Enrolled

3 Trials studying Breast Cancer

550 Patients Enrolled for Breast Cancer

Maisonneuve-Rosemont HospitalLead Sponsor

101 Previous Clinical Trials

38,263 Total Patients Enrolled

1 Trials studying Breast Cancer

10 Patients Enrolled for Breast Cancer

Media Library

Single Pre-Operative Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05217966 — N/A

Breast Cancer Research Study Groups: Preoperative radiotherapy for early breast cancer

Breast Cancer Clinical Trial 2023: Single Pre-Operative Radiation Therapy Highlights & Side Effects. Trial Name: NCT05217966 — N/A

Single Pre-Operative Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05217966 — N/A

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