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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-5 years

Awards & highlights

SPORT-DNS Trial Summary

This trial is testing whether giving radiotherapy before surgery to women with early stage breast cancer will improve outcomes.

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.Check my eligibility

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.See study design

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.

SPORT-DNS Trial 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.

SPORT-DNS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of pathological complete response

Secondary outcome measures

Incidence of grade 3 or greater radiation toxicity

SPORT-DNS Trial Design

1Treatment groups

Experimental Treatment

Group I: Preoperative radiotherapy for early breast cancerExperimental Treatment1 Intervention

Radiation: Single Pre-Operative Radiation Therapy

0 / 9Eligibility 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.