Partial Breast Irradiation for Breast Cancer

Recruiting at 8 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Hormonal therapy

Disqualifiers: Distant metastasis, Pregnancy, BRCA mutation, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 5

110 Participants Needed

Trial Summary

What is the purpose of this trial?

Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast. However the investigators do not know if the whole breast needs to be receive radiation to better control your cancer or only a more limited area of the breast surrounding the tumor. The purpose of this study is to see the side effects of delivering partial breast irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the area of the breast where the cancer was removed. Another purpose of this study is to look long term at the rate at which cancer comes back in the same breast after PBI. WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a day, five days a week, for 2 weeks. In this study the investigators will learn about the good and bad effects of PBI radiation therapy. In this study, the investigators will also learn about how the breast looks after surgery and radiation therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking hormonal therapy as part of your breast cancer treatment, you may need to continue it as part of the trial.

What data supports the effectiveness of the treatment Partial Breast Irradiation for Breast Cancer?

Research shows that Accelerated Partial Breast Irradiation (APBI) is a safe and effective treatment for early-stage breast cancer, offering similar local control to whole-breast irradiation but in a shorter time. Studies have demonstrated that APBI can be a convenient option with comparable outcomes, especially when patients are carefully selected. ^{1 2 3 4 5}

Is partial breast irradiation safe for humans?

Accelerated partial breast irradiation (APBI) is generally considered safe for treating early-stage breast cancer, with studies showing it is well-tolerated and associated with manageable side effects. ^{1 2 3 5 6}

How is Partial Breast Irradiation different from other breast cancer treatments?

Partial Breast Irradiation (PBI) is unique because it targets only the part of the breast where cancer was removed, rather than the whole breast, and it is completed in a shorter time frame, typically 1 to 5 days, compared to traditional whole breast irradiation. ^{1 2 3 4 5}

Research Team

Simon Powell, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for women over 18 with early-stage invasive ductal breast cancer or Grade 1/2 DCIS, measuring less than 2 cm. They must have a performance status indicating they can carry out daily activities without significant restrictions and adequate blood cell counts. Exclusions include prior breast surgeries, psychiatric conditions affecting consent, other ongoing cancer treatments, pregnancy/breastfeeding, certain genetic mutations like BRCA, and uncontrolled medical conditions.

Inclusion Criteria

My breast cancer is early stage, small, and confirmed by tests at MSKCC.

My cancer is in an early stage and was found in a sentinel lymph node but is very small.

I am fully active or can carry out light work.

Exclusion Criteria

My cancer has spread to distant parts of my body.

Patients who are pregnant or breastfeeding

My cancer shows signs of spreading through lymph or blood vessels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive partial breast irradiation (PBI) with external-beam radiation therapy for 2 weeks

2 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of local control rates

1 year

Treatment Details

Interventions

• Partial Breast Irradiation (PBI)

Trial Overview The study tests Partial Breast Irradiation (PBI) as an alternative to Whole Breast Irradiation (WBI) in treating early-stage breast cancer post-lumpectomy. PBI targets only the tumor area for two weeks instead of the entire breast for five to seven weeks. The goal is to assess side effects and how effectively PBI prevents cancer recurrence.

Participant Groups

Group I: Radiation treatment Experimental Treatment 1 Intervention

This is a Phase II single-arm study of PBI with external-beam radiation therapy in which a group of select women with early-stage invasive and noninvasive breast cancer will be given radiation to the partial breast.

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

Approved in United States as Partial Breast Irradiation for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in European Union as Partial Breast Irradiation for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in Canada as Partial Breast Irradiation for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Accelerated partial breast irradiation (APBI) is linked to a higher local recurrence rate of breast cancer compared to whole-breast irradiation (WBI), with a significant hazard ratio of 4.54 based on a meta-analysis of 1407 participants.

Despite the increased local recurrence with APBI, there were no significant differences in nodal recurrence, systemic recurrence, overall survival, or mortality rates between the two treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial irradiation for breast cancer: systematic review and meta-analysis of 8653 women in eight randomized trials. Marta, GN., Macedo, CR., Carvalho, Hde A., et al.[2022]

In a study of 290 patients receiving accelerated partial breast irradiation (APBI) with a median follow-up of 8 years, the rate of ipsilateral breast tumor recurrence (IBTR) was significantly higher (6.2%) compared to 1.0% in 290 patients receiving whole breast irradiation (WBI), indicating a greater risk of recurrence with APBI.

Despite the higher recurrence rates, APBI was associated with significantly fewer toxicities, such as fatigue and skin reactions, suggesting that while APBI may pose a higher risk of cancer recurrence, it offers a more tolerable treatment experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single Institution Retrospective Comparison Study of Locoregional Recurrence After Accelerated Partial Breast Irradiation Using External Beam Fractionation Compared with Whole Breast Irradiation with 8 Years of Follow-Up. Shah, S., Kyrillos, A., Kuchta, K., et al.[2018]

Accelerated partial breast irradiation (APBI) is a promising new radiotherapy method for breast cancer patients, showing local control rates comparable to traditional whole breast radiotherapy in recent studies.

Ongoing phase III trials are investigating the safety and efficacy of various APBI techniques to determine if they can effectively replace whole breast radiotherapy for women opting for breast conservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: where do we stand? Dirbas, FM.[2019]

Accelerated partial breast irradiation (APBI) is a highly effective and well-tolerated treatment for early-stage breast cancer, particularly for women who meet specific criteria such as being over 40 years old and having tumors smaller than 3 cm.

APBI offers a convenient treatment option post-lumpectomy, making it important for patients and caregivers to consider this approach for managing early-stage breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Partial Breast Irradiation: A Safe, Effective, and Convenient Early Breast Cancer Treatment Option. Thomas, MA., Ochoa, LL., Zygmunt, TM., et al.[2018]

In a study of 55 patients undergoing accelerated partial breast irradiation (APBI), common acute toxicities included moderate breast enlargement (22% of patients) and severe skin toxicity (27%), with symptoms typically resolving by 8 weeks post-treatment.

Despite the reported toxicities, the study found no significant correlation between dosimetric parameters and the severity of symptoms, indicating that further research is needed to better understand how treatment planning may influence patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Partial Breast Irradiation: Association of Dosimetric Parameters With Patient-Reported Outcomes. Lapen, K., Fiasconaro, M., Zhang, Z., et al.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Accelerated partial irradiation for breast cancer: systematic review and meta-analysis of 8653 women in eight randomized trials. [2022]

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

A Single Institution Retrospective Comparison Study of Locoregional Recurrence After Accelerated Partial Breast Irradiation Using External Beam Fractionation Compared with Whole Breast Irradiation with 8 Years of Follow-Up. [2018]

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

Breast conservation therapy utilizing partial breast brachytherapy for early-stage cancer of the breast: a retrospective review from the Saint Luke's Cancer Institute. [2015]

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

Accelerated partial breast irradiation: where do we stand? [2019]

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

Accelerated Partial Breast Irradiation: A Safe, Effective, and Convenient Early Breast Cancer Treatment Option. [2018]

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

Accelerated Partial Breast Irradiation: Association of Dosimetric Parameters With Patient-Reported Outcomes. [2023]