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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether radiotherapy alone after a lumpectomy can effectively treat early-stage, low-risk breast cancer. Researchers aim to learn more about this treatment for women aged 60 or older who have undergone breast-conserving surgery. The trial targets patients with hormone receptor-positive breast cancer, meaning their cancer grows in response to hormones like estrogen. Those who have discussed further treatment with a breast specialist and have not started or recently stopped hormone therapy might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in breast cancer care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous research has shown that adjuvant radiotherapy, a type of targeted cancer treatment, is safe and well-tolerated for breast cancer patients. Studies involving over 900 patients who received this therapy reported good safety results. One study found that radiation therapy improved quality of life and had fewer side effects compared to treatments like hormone therapy. These findings suggest that adjuvant radiotherapy is generally safe for patients, with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about adjuvant radiotherapy for breast cancer because it offers a targeted approach to eliminating residual cancer cells after surgery. Unlike systemic treatments like chemotherapy that affect the whole body, adjuvant radiotherapy focuses high-energy rays precisely on the breast, minimizing damage to surrounding healthy tissue. This precision can lead to fewer side effects and potentially improve the quality of life for patients. Additionally, combining radiotherapy with endocrine therapy may enhance effectiveness by addressing different pathways that contribute to cancer recurrence. This dual approach aims to increase survival rates and reduce the chances of cancer coming back.

What evidence suggests that adjuvant radiotherapy might be an effective treatment for early-stage, low-risk breast cancer?

Research has shown that radiotherapy after surgery effectively treats early-stage, low-risk breast cancer. A large study found that this approach can halve the chance of cancer recurrence and decrease the risk of dying from breast cancer. Another study with over 900 patients demonstrated that a specific radiotherapy method led to successful results. These findings strongly support using radiotherapy after surgery to improve patient outcomes. Participants in this trial will receive either adjuvant radiotherapy or endocrine therapy to evaluate the effectiveness of these treatments. ^{1 3 6 7 8}

Who Is on the Research Team?

Simona Shatelman, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9131773/

Adjuvant radiation therapy in breast cancer The largest study reported is by Chatterjee et al34, who have reported outcomes of more than 900 patients treated with a uniform protocol of 40 Gy/15#/three- ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2207586

Breast-Conserving Surgery with or without Irradiation in ... Overall survival at 10 years was almost identical in the two groups, at 80.8% (95% CI, 77.2 to 84.3) with no radiotherapy and 80.7% (95% CI, ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839036

Adjuvant Radiation and Endocrine Therapy in Early-Stage ... Our results show that a variety of adjuvant therapy options are associated with acceptably low LRR, and younger patients with low genomic risk ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814025051795

Adjuvant radiotherapy alone, an effective treatment option ... The Early Breast Cancer Trialists' Collaborative Group (EBCTCG) overview observed that RT halves the risk of recurrence and reduces BC mortality ...

5. ascopubs.org ascopubs.org/doi/10.1200/OP.21.00635

Advances in Breast Cancer Radiotherapy: Implications for ... Outcomes from the Early Breast Cancer Trialists Group meta-analysis confirmed the benefit of adjuvant RT (including RNI) in patients with one ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820925002344

Real World Safety of Adjuvant Ultra Hypofractionated ... Adjuvant radiotherapy (RT) improves local control and progression-free survival rates after conservative or radical surgery in breast cancer.

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2302344

Omitting Radiotherapy after Breast-Conserving Surgery in ... Adjuvant radiotherapy is prescribed after breast-conserving surgery to reduce the risk of local recurrence. However, radiotherapy is inconvenient, costly, and ...

8. cancernetwork.com cancernetwork.com/view/exclusive-radiation-therapy-improves-qol-and-safety-outcomes-in-breast-cancer

Exclusive Radiation Therapy Improves QOL and Safety ... When compared with endocrine therapy, radiation therapy improved quality of life and adverse effects data, the phase 3 EUROPA study showed.