SABR for Breast Cancer

(CARMEN Trial)

Overseen By Lauren Clinical Research Coordinator

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Chemotherapy

Disqualifiers: Multicentric tumor, Distant metastases, Autoimmune conditions, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new non-surgical treatment called SABR, a type of targeted radiation therapy, for women aged 65 and older with a specific type of early-stage breast cancer. It evaluates how well SABR treats breast cancer that is ER-positive and HER2-negative, where cancer cells grow in response to estrogen but lack extra HER2 protein. Participants will receive five SABR treatments and will be monitored for side effects and changes in quality of life. Women with breast cancer up to 5 cm in size and no lymph node involvement might be suitable candidates, even if they have previously undergone hormone therapy. As an unphased trial, this study offers a unique opportunity to explore new treatment options and contribute to advancing breast cancer care.

Will I have to stop taking my current medications?

The trial requires you to stop any breast cancer chemotherapy before enrolling. It doesn't specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that SABR is safe for treating breast cancer?

Research shows that SABR (Stereotactic Ablative Body Radiotherapy) is generally safe and well-tolerated. As a non-invasive treatment, it does not involve surgery and is effective for certain types of breast cancer. Studies have found that SABR successfully treats breast cancer that has spread, with few serious side effects reported.

Safety data from previous trials indicate that patients usually handle SABR well, experiencing only minor side effects. These may include skin redness or tiredness, similar to what some people feel with other types of radiation therapy. Overall, the treatment is considered safe, making it a promising option for those seeking non-surgical alternatives. ^{1 2 3 4 5}

Why are researchers excited about this trial?

SABR (Stereotactic Ablative Radiotherapy) for breast cancer is unique because it offers a non-surgical approach to treating tumors, which can be especially appealing for patients who cannot undergo surgery. Unlike traditional treatments like surgery or chemotherapy, SABR delivers high doses of radiation precisely to the cancer site over just a few sessions, minimizing damage to surrounding healthy tissue. Researchers are excited about SABR because it can potentially control or shrink tumors quickly and with fewer side effects, improving the quality of life for patients. Plus, it allows flexibility with other treatments like endocrine therapy, which can be tailored to individual patient needs.

What evidence suggests that SABR is effective for breast cancer?

Research shows that Stereotactic Ablative Body Radiotherapy (SABR) is a promising non-invasive treatment for some breast cancers. In this trial, participants will receive SABR without surgery. A review found that SABR successfully controls tumors in 90% to 94% of cases, stopping tumor growth in most patients. Another study discovered that nearly half of the patients experienced no worsening of their disease for at least six months after treatment. Additionally, in a smaller trial, most patients saw their tumors shrink or disappear completely. These findings suggest that SABR could effectively treat certain types of breast cancer in older women. ^{1 2 3 6 7}

Who Is on the Research Team?

Morse, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for women aged 65 and older with a specific breast cancer type (ER-positive, HER2-negative) that's no larger than 5 cm without spread to lymph nodes. It includes those who've been on hormone therapy before.

Inclusion Criteria

Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information

Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial

I am a woman aged 65 or older.

Exclusion Criteria

Autoimmune conditions with associated radiation risks

I have had radiation therapy on the same side of my chest or breast before.

My cancer has multiple centers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive SABR targeting the tumor consisting of 5 total treatments

2 weeks

5 visits (in-person, every other day)

Follow-up

Participants are monitored for quality of life and treatment-related toxicity

12 months

Regular visits as per protocol

Long-term follow-up

Estimation of long-term survival outcomes at 2 and 5 years post-radiation

5 years

What Are the Treatments Tested in This Trial?

Interventions

• SABR

Trial Overview The study tests SABR (Stereotactic Ablative Radiotherapy), a focused radiation treatment given in five sessions as an alternative to surgery. The effects on patients' quality of life and any side effects are closely monitored afterwards.

How Is the Trial Designed?

Group I: SABR Intervention Without Surgery (Single Arm Only) Experimental Treatment 1 Intervention

Radiotherapy will be conducted in 5 fractions, every other day. The radiation dose used in this study will use a standard of care post-operative dose of 600 cGy per fraction at 5 total fractions delivered to the clinical target volume. However, since patients in this study will have gross disease and will not have received surgery, a higher dose will be given to the primary tumor itself. Study participants may not receive chemotherapeutic agents after enrollment, unless indicated for disease progression. Patients will be allowed to receive CKD 4/6 inhibitors. Patients will be allowed on this study whether they do or do not receive anti-hormonal therapy. If a patient has not started endocrine therapy before SABR, ideally, they would initiate endocrine therapy after undergoing SABR. If a patient has already started endocrine therapy before SABR, they may continue during the time of SABR at the discretion of the treating physician, as this is considered safe in this setting.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38575431/

Treatment Outcomes of Stereotactic Ablative Body ... This study confirmed that SABR was a safe, non-invasive treatment option for patients with extracranial OM and OP diseases originated from primary breast ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0936655524001092

Treatment Outcomes of Stereotactic Ablative Body ... This study confirmed that SABR was a safe, non-invasive treatment option for patients with extracranial OM and OP diseases originated from primary breast cancer ...

3. ascopubs.org ascopubs.org/doi/10.1200/OA-25-00031

A Phase II Prospective Multicenter Trial In this study of 32 patients, nearly half were able to stay on their current treatment without disease progression for at least 6 months, and ...

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

Success Rate and Survival After Stereotactic Radiotherapy The review found SRS effectively overcomes limitations of WBRT, showing reproducible local tumor control with high rates: 90–94% for breast ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1062355/full

BOMB trial: First results of stereotactic radiotherapy to ... Median follow-up was 13 months and all 10 patients were evaluable for response: 5 achieved a complete response, 3 achieved a partial response ...

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2773455

Safety and Survival Rates Associated With Ablative ... The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.

7. thegreenjournal.com thegreenjournal.com/article/S0167-8140(21)08752-1/abstract

Stereotactic body radiotherapy to treat breast cancer ... Conclusion. SABR for oligometastatic breast cancer is safe and associated with high rates of local control. Longer follow-up of existing data and ongoing ...