APBI for Improved Breast Appearance in Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jose G Bazan

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the breast (partial breast) instead of the whole breast or chest area as in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole breast radiation therapy, over fewer days instead of several weeks, with a lower total dose of radiation. APBI is currently given every other business day for a total of 5 treatments with excellent results; however, a shorter treatment duration could have similar or even better results. Undergoing APBI every day on consecutive business days for 5 treatments may result in an improved breast appearance for patients with low risk hormone responsive breast cancer.

Research Team

Jose G Bazan

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for women over 40 with early-stage, hormone-sensitive breast cancer who've had surgery with clear margins and no lymph node involvement. They must not be pregnant, breastfeeding, or have had prior cancer treatments. Participants need to agree to birth control use and understand English or Spanish.

Inclusion Criteria

My breast cancer surgery included checking the lymph nodes, which were cancer-free.

My cancer is in the earliest stage.

I had breast surgery with all cancer removed, confirmed by tests.

Exclusion Criteria

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

I've had radiation on my breast that may not allow for more targeted radiation.

I have received treatments like radiation or hormone therapy for my current breast cancer before surgery.

Treatment Details

Interventions

• Accelerated Partial Breast Irradiation (Radiation)

Trial Overview The study tests a once-daily accelerated partial breast irradiation (APBI) regimen over consecutive business days for five treatments. APBI targets only the affected area of the breast rather than the whole breast, aiming for better cosmetic outcomes in low-risk patients.

Participant Groups

Group I: Supportive care (APBI) Experimental Treatment 1 Intervention

Patients undergo APBI QD on consecutive business days for 5 treatments.

Accelerated Partial Breast Irradiation is already approved in Canada for the following indications:

Approved in Canada as APBI for:

• Early-stage breast cancer
• Ductal carcinoma in situ (DCIS)
• Stage I or II breast cancer

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School