Radiation Omission for Breast Cancer

Overseen By Michelle Faucheux, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must be taking: Trastuzumab

Disqualifiers: Inflammatory breast cancer, metastatic, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 year

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the use of medications after surgery in patients aged 40 and older with a specific type of early-stage breast cancer. These medications help prevent the cancer from coming back by blocking growth signals in cancer cells. Adding another medication to the treatment has been shown to significantly improve patient outcomes.

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, since the trial involves chemotherapy and trastuzumab, it's best to discuss your current medications with the trial team to ensure there are no interactions.

What data supports the effectiveness of omitting radiation treatment for breast cancer?

Research shows that skipping radiation therapy after surgery is a reasonable option for older women with early-stage breast cancer, especially if they have a favorable prognosis. Studies indicate that this approach can be an acceptable choice without significantly increasing the risk of cancer returning. ^{1 2 3 4 5}

Is it safe to omit radiation therapy in older women with early-stage breast cancer?

Studies show that skipping radiation therapy in older women with early-stage breast cancer is generally considered safe and is an acceptable option. This approach has been supported by research, especially when combined with other treatments like endocrine therapy. ^{1 2 3 4 6}

How does the omission of radiation treatment differ from other breast cancer treatments?

The omission of radiation treatment for older women with early-stage, estrogen-receptor-positive breast cancer is unique because it allows patients to avoid radiation therapy after surgery if they are receiving hormone therapy, which can reduce treatment burden and potential side effects. ^{1 3 4 7 8}

Research Team

Shane Stecklein, MD, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for postmenopausal women aged 40 or older with early-stage HER-2 positive breast cancer who've had a complete response to chemotherapy and lumpectomy. Participants must have no evidence of residual disease, be in good health (Karnofsky Performance Status 50% to 100%), and agree to sign informed consent.

Inclusion Criteria

Your Her-2 test results show a high level of a specific protein or gene.

Only women who have gone through menopause will be eligible. This means they have not had a period for at least one year, have had both ovaries removed, or have specific hormone levels as per the clinic's standards.

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

You have been diagnosed with a disease that has spread to other parts of your body.

You have had a cancer diagnosis, except for certain types of skin cancer, and have been cancer-free for at least 5 years.

You have been diagnosed with inflammatory breast cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy as per medical oncologist's plan

Varies

Surgery

Participants undergo lumpectomy with sentinel lymph node biopsy

1 day

Treatment

Participants continue trastuzumab +/- pertuzumab therapy to complete a full year of therapy

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up assessments every 3 months up to 5 years post-op

5 years

Every 3 months (in-person)

Treatment Details

Interventions

• Omission of Radiation

Trial Overview The study aims to see if omitting radiation therapy after successful chemotherapy and lumpectomy can still maintain local control of the cancer in patients with HER-2 positive early-stage breast cancer.

Participant Groups

Group I: Arm A Experimental Treatment 1 Intervention

Patient is required to have lumpectomy with sentinel lymph node biopsy shows pCR and will complete 1 year of trastuzumab +/- pertuzumab treatment. No radiation, or an omission of radiation, will be given on this arm, including external beam, brachytherapy or intraoperative radiation. Patients will be required to follow up with a medical, surgical, or radiation oncologist every 3 months for 5 years. At these follow up visits, a physical exam will be performed to assess for any disease recurrence. Screening mammogram or MRI is recommended every 6 months for patients on this arm.

Group II: Arm B Active Control 1 Intervention

Patient is required to have her-2 positive breast cancer, clinically node negative from exam. Patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens such as blood and urine, for correlative studies.

Group III: Arm C Active Control 1 Intervention

Patient is required to have her-2 positive breast cancer, clinically node negative from exam. patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will not undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens, such as blood and urine, for correlative studies.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

In a study of 13,321 older women with stage I ER+ breast cancer, those who did not receive any treatment (neither radiation therapy nor endocrine therapy) had a significantly higher risk of developing second breast cancer events compared to those who received both treatments.

Radiation therapy alone did not increase the risk of second breast cancer events, suggesting it may be a safe option for older patients, while the omission of endocrine therapy was linked to a higher risk of recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Without Endocrine Therapy in Older Women With Stage I Estrogen-Receptor-Positive Breast Cancer is Not Associated With a Higher Risk of Second Breast Cancer Events. Gerber, NK., Shao, H., Chadha, M., et al.[2022]

Omitting endocrine therapy in older women receiving adjuvant radiation after breast-conserving surgery may provide similar local control and survival rates, suggesting a potential alternative treatment strategy for those who struggle with endocrine therapy side effects.

Current evidence on this approach is limited, highlighting the necessity for future prospective, randomized studies to better understand the outcomes of omitting endocrine therapy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Adjuvant Treatment Recommendations for Older Women with Biologically Favorable Breast Cancer: Short-Course Radiation or Long-Course Endocrine Therapy? McDuff, SGR., Blitzblau, RC.[2023]

In a study of 1105 older women with low-risk breast cancer, omitting adjuvant radiation treatment after breast-conserving surgery did not increase the risk of cancer-specific death in the short term (5- and 10-year follow-up) for those with moderate to high comorbidity burden.

However, for women with low comorbidity burden, omitting radiation treatment may double the risk of long-term cancer-specific death, indicating that further research is needed to understand the implications of this treatment choice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between adjuvant radiation treatment and breast cancer-specific mortality among older women with comorbidity burden: A comparative effectiveness analysis of SEER-MHOS. Lee, E., Hines, RB., Zhu, J., et al.[2023]

References

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

Radiation Without Endocrine Therapy in Older Women With Stage I Estrogen-Receptor-Positive Breast Cancer is Not Associated With a Higher Risk of Second Breast Cancer Events. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Does persistent use of radiation in women > 70 years of age with early-stage breast cancer reflect tailored patient-centered care? [2021]

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

Patient views and correlates of radiotherapy omission in a population-based sample of older women with favorable-prognosis breast cancer. [2023]

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

The Effect of Surgeon Referral and a Radiation Oncologist Productivity-Based Metric on Radiation Therapy Receipt Among Elderly Women With Early Stage Breast Cancer: Analysis From a Tertiary Cancer Network. [2023]

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

Radiotherapy omission after breast-conserving surgery is associated with reduced breast cancer-specific survival in elderly women with breast cancer. [2006]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Optimizing Adjuvant Treatment Recommendations for Older Women with Biologically Favorable Breast Cancer: Short-Course Radiation or Long-Course Endocrine Therapy? [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Adjuvant radiation use in older women with early-stage breast cancer at Johns Hopkins. [2018]

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

Association between adjuvant radiation treatment and breast cancer-specific mortality among older women with comorbidity burden: A comparative effectiveness analysis of SEER-MHOS. [2023]