Stereotactic Radiation for Breast Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Raloxifene, Tamoxifen, SERMs

Disqualifiers: Advanced breast cancer, Previous radiation, Others

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

Compensation: Varies

Number of Visits: 4

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any hormonal agents like raloxifene, tamoxifen, or other selective estrogen receptor modulators before joining. If you're on endocrine therapy, you must stop it at least 28 days before starting the study.

What data supports the effectiveness of the treatment Stereotactic Radiation for Breast Cancer?

There is growing evidence that stereotactic body radiation therapy is a safe and effective new treatment for early stage breast cancer, as it reduces treatment volumes and doses to nearby organs, potentially improving outcomes. ^{1 2 3 4 5}

Is stereotactic radiation generally safe for humans?

Stereotactic radiation therapy has been studied for various conditions, including lung and breast cancer. While it can be effective, there are potential risks, such as heart disease from breast cancer radiotherapy and severe complications in paraspinal treatments. However, techniques to minimize these risks are being developed, and for many patients, the benefits may outweigh the risks. ^{6 7 8 9 10}

How is stereotactic radiation treatment different from other breast cancer treatments?

Stereotactic radiation treatment for breast cancer is unique because it delivers high doses of focused radiation to the tumor with precision, potentially allowing patients to avoid surgery while achieving good cosmetic outcomes. This method uses advanced technology to target the tumor accurately, minimizing damage to surrounding healthy tissue. ^{11 12 13 14 15}

What is the purpose of this trial?

Radiation, Stereotactic Body Radiation Therapy.

Research Team

Asal Rahimi, MD

Principal Investigator

UTSW Medical Center

Eligibility Criteria

This trial is for adults with early-stage breast cancer (stage 0, I, or II) who've had a lumpectomy with clear margins and no tumor larger than 3 cm. Participants must be disease-free from other cancers for at least a year, able to consent, not pregnant or breastfeeding, and willing to use contraception during the study.

Inclusion Criteria

Willing and able to provide consent

My breast cancer is in an early stage (0, I, or II) and if stage II, my tumor is 3 cm or smaller.

I had a lumpectomy with all cancer removed, confirmed by tests.

Exclusion Criteria

I have suspicious lymph nodes near my collarbone or breastbone not proven negative by biopsy.

Pregnancy or lactation at the time of registration. For women of childbearing age, they must agree to use effective contraceptive methods such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills

You have certain autoimmune diseases like dermatomyositis, systemic lupus erythematosus, or scleroderma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive a single fraction of stereotactic body partial breast irradiation using the Cyberknife system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and cosmesis after radiation treatment

5 years

Follow-up visits at months 3, 6, 12, 18, 24, 36, 48, and 60

Treatment Details

Interventions

• Stereotactic Radiation

Trial Overview The trial is testing how safe and effective Stereotactic Body Radiation Therapy (SBRT) is as a single fraction adjuvant treatment in patients who have undergone surgery for early-stage breast cancer.

Participant Groups

Group I: Stereotactic Radiation Experimental Treatment 1 Intervention

Single Fraction Stereotactic Radiation. Step No. Fractions Dose per fraction -1 1 20 0 (starting) 1 22.5 1. 1 26.5 2. 1 30

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

Radiation therapy is an effective treatment for both ductal carcinoma in situ (DCIS) and invasive breast cancer, with lumpectomy followed by radiation being particularly effective for DCIS.

Shorter radiation schedules are just as effective as traditional longer regimens for early breast cancer, and postmastectomy radiation provides survival benefits for high-risk premenopausal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation treatment for breast cancer. Recent advances. Chow, E.[2018]

In a randomized phase 2 trial involving 98 medically inoperable patients with early-stage non-small cell lung cancer, a single fraction of 30 Gy was found to be as effective as 60 Gy delivered in three fractions regarding toxicity and cancer control outcomes.

Patients receiving the single fraction treatment reported better social functioning and less dyspnea at the 6-month follow-up, suggesting that 30 Gy in 1 fraction may improve quality of life compared to the 60 Gy in 3 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial. Singh, AK., Gomez-Suescun, JA., Stephans, KL., et al.[2021]

A comprehensive risk analysis of the paraspinal SBRT workflow identified 74 potential failure modes across various phases, with treatment planning being a significant source of safety concerns.

The highest risks were linked to inadequate evaluation of previous radiotherapy, incorrect imaging registration, and undetected patient movement, prompting the implementation of targeted remedies like staff education and improved imaging protocols to enhance treatment safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. Lee, S., Lovelock, DM., Kowalski, A., et al.[2021]

Stereotactic radiosurgery for brain metastases from breast cancer showed a high tumor control rate of 93% and a median survival of 13 months post-treatment, indicating its efficacy as a treatment option.

The absence of multiple brain metastases was the only significant factor associated with longer survival, while the treatment had a low complication rate, with only a few cases of radiation-induced edema that did not require further surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for brain metastases from breast cancer. Firlik, KS., Kondziolka, D., Flickinger, JC., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Oligometastatic Breast Cancer: A Retrospective Multicenter Study. [2023]

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

Importance of extracranial disease status and tumor subtype for patients undergoing radiosurgery for breast cancer brain metastases. [2022]

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

Salvage stereotactic radiosurgery for breast cancer brain metastases: outcomes and prognostic factors. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Radiation treatment for breast cancer. Recent advances. [2018]

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

New Techniques for Irradiating Early Stage Breast Cancer: Stereotactic Partial Breast Irradiation. [2018]

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

One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Cardiac Side-effects From Breast Cancer Radiotherapy. [2022]

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

Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

BOMB trial: First results of stereotactic radiotherapy to primary breast tumor in metastatic breast cancer patients. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Ten-year experience of bone SBRT in breast cancer: analysis of predictive factors of effectiveness. [2023]

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

Stereotactic body radiotherapy with CyberKnife for cardiac malignancies. [2018]

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

Stereotactic radiosurgery for brain metastases from breast cancer. [2019]

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

Principles and Applications of Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy. [2020]

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

Phase 1 clinical trial of stereotactic body radiation therapy concomitant with neoadjuvant chemotherapy for breast cancer. [2022]

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

Definitive Radiotherapy With SBRT or IMRT Boost for Breast Cancer: Excellent Local Control and Cosmetic Outcome. [2019]