Partial Breast Irradiation with CyberKnife for Breast Cancer

(CKPBI Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Essentia Health

Disqualifiers: Prior radiotherapy, Neoadjuvant chemotherapy, Multicentric disease, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

20 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.

What data supports the effectiveness of the treatment CyberKnife for breast cancer?

CyberKnife, a type of advanced radiation therapy, has shown promise in treating various cancers, including prostate, pancreatic, lung, and uterine cervical cancers, by delivering precise, high doses of radiation to tumors. This method has been associated with good local control of the disease and maintaining a good quality of life for patients. ^{1 2 3 4 5}

Is CyberKnife treatment generally safe for humans?

CyberKnife treatment, also known as stereotactic body radiation therapy (SBRT), has been studied for various conditions like lung cancer, prostate cancer, and liver cancer. These studies have shown that it is generally safe for humans, with promising results in terms of local control and tolerance. ^{1 6 7 8 9}

How is the CyberKnife treatment different from other breast cancer treatments?

The CyberKnife treatment for breast cancer is unique because it uses advanced technology to deliver precise, high doses of radiation to a specific area of the breast, allowing for fewer treatment sessions. This method, known as stereotactic body radiotherapy (SBRT), can be an alternative to surgery and aims to maintain a good quality of life by minimizing damage to surrounding healthy tissue. ^{1 3 4 10 11}

What is the purpose of this trial?

The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).

Research Team

Ken Dornfeld, MD

Principal Investigator

Essentia Health Oncology

Eligibility Criteria

This trial is for individuals aged 60 or older with early-stage breast cancer, specifically unicentric invasive ductal malignancy at stage T1. Participants must have had a lumpectomy with clear margins of at least 2mm and no nodal metastases (N0). They should not have received prior radiotherapy to the breast, chemotherapy before surgery, or have multicentric disease or node-positive disease.

Inclusion Criteria

My cancer surgery removed all visible cancer with a clear margin of at least 2mm.

The trial is only open to individuals with cancer that is located in one specific area of the body.

My cancer is estrogen receptor positive.

Exclusion Criteria

My breast cancer has a significant intraductal component.

My cancer is present in multiple locations within the same organ.

My cancer has spread to nearby lymph nodes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive accelerated stereotactic radiotherapy using CyberKnife for partial breast irradiation, delivered twice daily for five days

1 week

10 sessions (in-person)

Follow-up

Participants are monitored for disease control and toxicity, with periodic physical exams and imaging for 5 years

5 years

Treatment Details

Interventions

• CyberKnife

Trial Overview The study tests if CyberKnife stereotactic radiotherapy is a feasible and safe option for partial breast irradiation after lumpectomy. It involves ten sessions over five days. The focus will be on short-term and long-term safety as well as effectiveness in tumor control and potential failure sites.

Participant Groups

Group I: Stereotactic radiotherapy Experimental Treatment 2 Interventions

Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.

CyberKnife is already approved in United States, European Union, Canada for the following indications:

Approved in United States as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Approved in European Union as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Approved in Canada as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Who Is Running the Clinical Trial?

Essentia Health

Lead Sponsor

Trials

27

Recruited

107,000+

Findings from Research

Cyberknife stereotactic body radiation therapy (SBRT) delivers high doses of radiation in fewer sessions, making it a promising alternative to surgery for early-stage primary cancers and for patients with oligometastatic disease.

Despite some uncertainties about the effects of hypofractionation, early results show good local control and patient tolerance, leading to increased use of this treatment under strict quality assurance and ongoing clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. Thariat, J., Marcié, S., Marcy, PY., et al.[2018]

The Cyberknife® system, used for stereotactic body radiation therapy (SBRT), shows promising efficacy in treating localized prostate cancer, with median PSA levels dropping significantly after treatment and biochemical progression-free survival rates ranging from 78.3% to 100% over a follow-up period of 4 to 60 months.

While the treatment is associated with mostly mild side effects (grade 1/2), there are reports of erectile dysfunction and some grade 3 toxicities, indicating a need for further long-term studies and randomized trials to establish its safety and effectiveness as a standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. Seisen, T., Drouin, SJ., Phé, V., et al.[2018]

CyberKnifeTM stereotactic body radiotherapy (SBRT) showed effectiveness in reducing the size of tumors in patients with advanced pancreaticobiliary malignancies, with an average decrease in tumor size observed in the first three months after treatment.

However, serious complications were reported, including two cases of massive duodenal ulcer bleeding, highlighting the need for careful monitoring and further studies to evaluate the safety and long-term efficacy of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An experience of cyberknife treatment in patients with advanced pancreaticobilliary malignancy]. Jung, YH., Choi, HS., Cheon, YK., et al.[2019]

In a study of 106 patients with early-stage non-small cell lung cancer treated with CyberKnife® SBRT, the treatment demonstrated an 88% local control rate at 2 years, indicating its efficacy in managing this type of cancer.

The treatment was associated with low toxicity, with only 20% of patients experiencing mild fatigue and 17% mild dyspnea, and only 4% experiencing significant late effects, suggesting it is a safe option for medically inoperable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. Temming, S., Kocher, M., Stoelben, E., et al.[2022]

Stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer was found to be safe, with no severe treatment-related toxicities (grade 3 or higher) reported among 44 patients over a median follow-up of 40 months.

The treatment showed excellent efficacy, with a 100% cause-specific survival rate and progression-free survival rate, and a high biochemical failure-free rate of 90.8% for high-risk patients, particularly with the 34 Gy in 4 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic body radiation therapy for localized prostate cancer. Kang, JK., Cho, CK., Choi, CW., et al.[2022]

Cyberknife stereotactic body radiation therapy (SBRT) was found to be safe and effective for treating unresectable huge hepatocellular carcinoma (HCC), with an objective response rate of 86.3% and a median survival of 11 months among 22 patients treated between 2009 and 2011.

The study indicated that the dose of SBRT significantly influenced survival outcomes, with a 1-year overall survival rate of 50%, suggesting that SBRT could be a viable salvage treatment option for patients with large HCC, despite the risk of local and regional recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of stereotactic body radiation therapy on huge hepatocellular carcinoma unsuitable for other local modalities. Que, JY., Lin, LC., Lin, KL., et al.[2022]

Cyberknife stereotactic body radiation therapy (SBRT) demonstrated a 2-year overall survival rate of 64.0% in patients with recurrent hepatocellular carcinoma (HCC), significantly better than the 42.1% survival rate in matched controls not receiving SBRT.

The treatment was found to be safe, with only mild and tolerable acute toxicities, indicating that SBRT is an effective option for improving survival in patients with unresectable HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy in recurrent hepatocellular carcinoma. Huang, WY., Jen, YM., Lee, MS., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. [2018]

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

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. [2018]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

[An experience of cyberknife treatment in patients with advanced pancreaticobilliary malignancy]. [2019]

4. China pubmed.ncbi.nlm.nih.gov

Pattern of recurrence after CyberKnife stereotactic body radiotherapy for peripheral early non-small cell lung cancer. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Recurrent or Oligometastatic Uterine Cervix Cancer: A Cooperative Study of the Korean Radiation Oncology Group (KROG 14-11). [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. [2022]

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

Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]

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

The efficacy of stereotactic body radiation therapy on huge hepatocellular carcinoma unsuitable for other local modalities. [2022]

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

Stereotactic body radiation therapy in recurrent hepatocellular carcinoma. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer: Rationale, Feasibility, and Early Experience Using the CyberKnife Radiosurgery Delivery Platform. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic irradiation for metastatic brain tumors. [2022]