Stereotactic Radiation for Breast Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of stereotactic radiation therapy for treating breast cancer. It focuses on patients with specific types of early-stage breast cancer, such as ductal carcinoma in situ or certain invasive types, who have undergone lumpectomy (breast-conserving surgery). Ideal participants have breast cancer in a single location and have had surgery with clear margins, meaning no cancer cells at the edge of the removed tissue. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 prior data suggests that Stereotactic Radiation is safe for breast cancer?

Research has shown that stereotactic radiation is generally safe for breast cancer patients. One study found that patients with a small number of cancer spread areas did not experience serious side effects, indicating that the radiation doses were well-tolerated. Another study found stereotactic radiation to be a safe option for treating oligometastatic breast cancer, reporting high success in controlling the cancer, meaning it did not grow or spread in the treated area. Overall, these findings suggest that stereotactic radiation is a reliable and safe option for patients, with no major safety concerns reported in these studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic Radiation for breast cancer is unique because it delivers a highly focused, high-dose of radiation in just a single session. Unlike traditional radiation therapy, which often requires multiple sessions spread over several weeks, this method aims to minimize damage to surrounding healthy tissue while potentially speeding up treatment time. Researchers are excited because this precise approach could lead to fewer side effects and a more convenient treatment schedule for patients, making it a promising alternative to conventional radiation therapy options.

What evidence suggests that stereotactic radiation might be an effective treatment for breast cancer?

Research has shown that stereotactic radiation, the treatment under study in this trial, can effectively treat certain cancers. Studies have found that it controls cancer in the treated area 94.7% of the time. One study found that 85.4% of patients were still alive one year after treatment, which is encouraging. Additionally, 51.4% of patients experienced no worsening of their cancer, meaning it did not grow or spread. This suggests that stereotactic radiation might help manage breast cancer by preventing progression. ^{1 6 7 8 9}

Who Is on the Research Team?

Asal Rahimi, MD

Principal Investigator

UTSW Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10378468/

The Effectiveness and Safety of Stereotactic Body ...

Progression-free and overall survival ranged from 17 to 57% and 62 to 91%, respectively. There are limited data on the role of SBRT in ...

2.

redjournal.org

redjournal.org/article/S0360-3016(24)01253-7/fulltext

Efficacy of Stereotactic Body Radiation Therapy (SBRT) to ...

Follow-up data for disease outcomes was available in 46 of 51 patients with a median follow-up time of 15.5 mos (IQR, 9.4-24.4 mos) post-SBRT.

3.

oncodaily.com

oncodaily.com/oncolibrary/radiotherapy/stereotactic-radiotherapy-success

Success Rate and Survival After Stereotactic Radiotherapy

Estimated 1-year outcomes included a high local control rate of 94.7%, overall survival of 85.4%, and progression-free survival of 51.4%. The ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11609137/

Treatment of metastatic breast cancer by stereotactic body ...

Patients administered local ablative radiotherapy (SBRT/SRS) for oligometastases have better overall survival than those treated for oligoprogression.

5.

clinicaltrials.gov

clinicaltrials.gov/show/NCT03295916

Stereotactic Body Radiotherapy for Patients With Breast ...

A number of studies of systemic therapy in metastatic breast cancer have reported that patients with OM disease have a better prognosis compared to other ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0167814024001622

Definitive results of a prospective non-randomized phase 2 ...

Conclusion. SBRT is a safe and valid option in oligometastatic breast cancer patients, with very high rates of local control. An optimal selection of patients ...

7.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2778658

Evaluation of Safety of Stereotactic Body Radiotherapy for ...

Standard doses were safe in all 35 evaluable patients, with a median of 3 metastases; there were no protocol-defined dose-limiting toxicities, ...

8.

aacrjournals.org

aacrjournals.org/cancerres/article/83/5_Supplement/P1-10-05/716949/Abstract-P1-10-05-Safety-of-stereotactic-body

Abstract P1-10-05: Safety of stereotactic body radiation ...

The objective of our study is to assess toxicity among patients who received SBRT, stereotactic radiosurgery (SRS), or other high dose RT along ...

9.

ro-journal.biomedcentral.com

ro-journal.biomedcentral.com/articles/10.1186/s13014-024-02497-4

Advances in breast cancer treatment: a systematic review of ...

The Table 5 summarizes currently ongoing trials using preoperative stereotactic radiotherapy in the treatment of breast cancer.