APBI for Improved Breast Appearance in Breast Cancer

Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a shorter course of accelerated partial breast irradiation (APBI) can enhance breast appearance after treatment for low-risk, hormone-responsive breast cancer. APBI targets only the cancer-affected part of the breast, using precise radiation to eliminate cancer cells while preserving the rest of the breast. The trial aims to deliver this treatment over five consecutive days instead of the usual every-other-day schedule. It may suit women who have undergone breast-conserving surgery and have hormone-sensitive, early-stage breast cancer. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants, offering a chance to benefit from innovative care.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude those who have had prior treatment with anti-endocrine/hormone therapy for the current breast cancer before surgery.

What prior data suggests that accelerated partial breast irradiation is safe for patients with low risk, hormone responsive breast cancer?

Research has shown that accelerated partial breast irradiation (APBI) is a safe treatment for women with early-stage breast cancer. Studies have found it to be generally well-tolerated with few side effects. For instance, one study noted that most patients' symptoms resolved within eight weeks, with only 16% experiencing moderate symptoms at that time.

Another study discovered that APBI provides similar long-term results to whole breast radiotherapy, a more common treatment. Importantly, APBI targets a smaller area of the breast, reducing exposure to the rest of the breast and possibly minimizing changes in appearance and sensation. This method has been linked to low rates of cancer recurrence.

Overall, APBI offers a shorter treatment period compared to traditional whole breast radiation, resulting in fewer visits and less disruption to daily life, while maintaining safety and effectiveness.12345

Why do researchers think this study treatment might be promising?

Accelerated Partial Breast Irradiation (APBI) is unique because it targets only the part of the breast affected by cancer, rather than the entire breast. This focused approach means that treatment can be completed in just five business days, compared to several weeks with traditional whole breast radiation. Researchers are excited about APBI because it has the potential to reduce side effects and improve cosmetic outcomes, offering a quicker and less invasive option for patients with breast cancer.

What evidence suggests that accelerated partial breast irradiation is effective for improving breast appearance in breast cancer?

Research has shown that accelerated partial breast irradiation (APBI) can effectively treat early-stage breast cancer. In this trial, participants will receive APBI, which targets radiation directly to the area where the tumor was removed, protecting the rest of the breast. Studies have found that patients often experience fewer side effects and recover faster compared to those who undergo whole breast irradiation. APBI has successfully reduced the chance of cancer recurrence while preserving healthy breast tissue. It also offers the convenience of a shorter treatment period, usually completed in one to two weeks. Overall, APBI presents a promising option for patients seeking effective breast cancer treatment with fewer side effects.26789

Who Is on the Research Team?

JG

Jose G Bazan

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.
See 12 more

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.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo accelerated partial breast irradiation (APBI) once per day on consecutive business days for 5 treatments

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and cosmetic outcomes post-treatment

5 years
Visits at 1 month, 6 months, 1 year, and then yearly until 5 years post-APBI

What Are the Treatments Tested in This Trial?

Interventions

  • Accelerated Partial Breast Irradiation

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.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Supportive care (APBI)Experimental Treatment1 Intervention

Accelerated Partial Breast Irradiation is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as APBI for:
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Approved in European Union as APBI for:
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Approved in Canada as APBI for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Accelerated partial breast irradiation: Current evidence and ...

Accelerated partial breast irradiation (APBI) as a substitute for WBI for patients with early breast cancer is a hot spot in clinical research.

Resource Guide on Accelerated Partial Breast Irradiation

Partial breast irradiation (PBI) is a type of treatment where radiation is delivered locally to the area where the tumor was surgically removed (lumpectomy ...

Accelerated Partial Breast Radiation Therapy

Shorter treatment time; Minimized radiation exposure; Less invasive procedures; Greater success in saving healthy breast tissue. Our breast cancer radiation ...

Accelerated Partial Breast Irradiation Offers Best Value After ...

In addition to being the less costly radiation therapy, APBI was found to be more effective based on quality-adjusted life years. Within 90 days ...

Partial breast radiation therapy - external beam

Partial breast radiation therapy can be accelerated (APBI) and accomplished in as little as 1 to 2 weeks. APBI targets a high dose of radiation ...

Accelerated Partial Breast Irradiation: A Safe, Effective, and ...

Accelerated partial breast irradiation (APBI) is an excellent treatment option for many women with early stage breast cancer.

Accelerated Partial Breast Irradiation for Early-Stage ...

Among patients with ILC who received APBI after breast conserving surgery, we observed a 4-year LR rate of 3%. No regional or distant recurrences were observed, ...

Long-term outcomes of three distinct once-daily schedules ...

Once-daily accelerated partial breast irradiation is feasible. Long term outcomes are comparable with whole breast radiotherapy.

Quality of life in early breast cancer patients after adjuvant ...

Early BC patients treated with APBI showed non-inferior short-term and late HRQoL outcomes compared to hypo-WBI. In addition to previous ...