Adjuvant Radiotherapy for Breast Cancer

Overseen By Simona Shaitelman, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Node positive, Metastatic, Grade 3, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

300 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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Adjuvant Radiotherapy for Breast Cancer?

Adjuvant radiotherapy for breast cancer helps reduce the chance of cancer coming back and can improve survival rates, especially in patients who have had surgery to remove the cancer. New techniques in radiotherapy have made treatments shorter and more personalized, with fewer side effects. ^{1 2 3 4 5}

Is adjuvant radiotherapy for breast cancer safe?

Adjuvant radiotherapy for breast cancer can cause side effects like skin changes, arm swelling, and lung inflammation, but these are generally manageable. It's important to discuss potential side effects with your doctor to understand how they might affect you. ^{6 7 8 9 10}

How is adjuvant radiotherapy different from other breast cancer treatments?

Adjuvant radiotherapy for breast cancer is unique because it is used after surgery to reduce the risk of cancer returning, and it can be tailored to the patient's risk profile, allowing for shorter and more individualized treatments. Unlike some other treatments, it specifically targets the breast and sometimes regional lymph nodes, and newer techniques help minimize exposure to the heart and lungs, reducing long-term side effects. ^{1 3 5 11 12}

What is the purpose of this trial?

This clinical research study is to learn about the effects of giving radiotherapy alone after lumpectomy to patients who have early-stage, low-risk breast cancers and who are 60 years of age or older.

Research Team

Simona Shatelman, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals aged 60 or older with early-stage, low-risk breast cancer who have undergone a lumpectomy. Specific eligibility details are not provided but typically include health status and absence of certain medical conditions.

Inclusion Criteria

My cancer has not spread to my lymph nodes.

I am 60 years old or older.

I had surgery to remove part of my breast.

Exclusion Criteria

I have had radiation therapy on the breast with cancer.

My cancer has spread to nearby lymph nodes.

My cancer has spread to other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive radiotherapy as adjuvant monotherapy after lumpectomy

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Long-term follow-up

Participants are monitored for oncologic outcomes and survival rates

Up to 11 years

Treatment Details

Interventions

• Adjuvant Radiotherapy

Trial Overview The EMERALD study is testing the effects of using only radiotherapy after lumpectomy in patients with specific types of breast cancer to understand its impact on quality of life and disease control.

Participant Groups

Group I: Endocrine Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Adjuvant radiotherapy is crucial for reducing local recurrences in early breast cancer, with moderate hypofractionated whole-breast irradiation being the standard treatment.

Recent advancements in irradiation techniques allow for shorter and more personalized treatment plans, making therapy more tolerable and potentially leading to de-escalation of treatment intensity based on individual patient risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adjuvant radiation therapy for breast cancer]. Lange, T., Knöchelmann, AC., Bremer, M.[2023]

Regional radiotherapy targeting the internal mammary and medial supraclavicular lymph nodes significantly improves overall survival (OS) in breast cancer patients, with a hazard ratio of 0.88 across multiple trials involving over 7,000 participants.

In addition to improving OS, regional radiotherapy also enhances disease-free survival (DFS) and distant metastasis-free survival (DMFS), indicating its effectiveness in reducing cancer recurrence and spread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant radiotherapy of regional lymph nodes in breast cancer - a meta-analysis of randomized trials. Budach, W., Kammers, K., Boelke, E., et al.[2022]

Radiotherapy as an adjuvant treatment for breast cancer can improve 10-year local control by 11.1% and overall survival by 3.1% when applied according to evidence-based guidelines, based on a comprehensive review of literature.

The benefits of radiotherapy vary by cancer stage, with stage III cancers showing the highest local control improvement (13%) and overall survival benefit (20%), highlighting the importance of tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based estimation of local control and survival benefit of radiotherapy for breast cancer. Shafiq, J., Delaney, G., Barton, MB.[2016]

In a study of 703 Japanese women who underwent breast-conserving surgery and radiation therapy, common late adverse events included breast pain, fibrosis, and pneumonitis, with serious complications (Grade 2 or 3) occurring in only 3.8% of patients.

The cosmetic outcomes were favorable, with 69.1% of patients reporting excellent or good results, indicating that the treatment is effective not only in managing cancer but also in preserving breast appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter investigation of late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated whole-breast radiation therapy. Nozaki, M., Kagami, Y., Mitsumori, M., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Adjuvant radiation therapy for breast cancer]. [2023]

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

Adjuvant radiotherapy of regional lymph nodes in breast cancer - a meta-analysis of randomized trials. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Breast cancer: improving outcome following adjuvant radiotherapy. [2004]

4. Ireland pubmed.ncbi.nlm.nih.gov

An evidence-based estimation of local control and survival benefit of radiotherapy for breast cancer. [2016]

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

[Non-pharmalogical interventions and breast cancer: What benefit in addition to radiotherapy?] [2022]

6. Austria pubmed.ncbi.nlm.nih.gov

[Side effects of adjuvant therapies of breast cancer: their significance for the patient]. [2013]

7. India pubmed.ncbi.nlm.nih.gov

Late effects of cancer treatment in breast cancer survivors. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A multicenter investigation of late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated whole-breast radiation therapy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

CONcurrent ChEmotherapy and RadioTherapy in adjuvant treatment of breast cancer (CONCERT): a phase 2 study. [2023]

10. Spain pubmed.ncbi.nlm.nih.gov

Incidence of radiodermatitis and factors associated with its severity in women with breast cancer: a cohort study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Regional radiotherapy in high-risk breast cancer: is the issue solved? [2018]

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

Postoperative Radiotherapy After Breast-Conserving Surgery for Early-Stage Breast Cancer: A Review. [2022]