Partial Breast Irradiation for Breast Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether focusing radiation only on the area where breast cancer was removed is as effective as treating the whole breast. Traditional treatment covers the entire breast, but this study examines if a more targeted approach, known as partial breast irradiation, can reduce side effects while still preventing cancer recurrence. The treatment duration is shorter, lasting only two weeks instead of several weeks. Women with early-stage breast cancer who have had surgery to remove the tumor might be suitable candidates, especially if they haven't undergone breast reconstruction or radiation therapy before. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that partial breast irradiation is safe for breast cancer treatment?

Studies have shown that partial breast irradiation (PBI) safely treats early-stage breast cancer. Research indicates that PBI often causes fewer serious side effects than traditional whole breast irradiation (WBI), resulting in fewer severe reactions for patients.

A review of different PBI schedules demonstrated its effectiveness and similar long-term results to WBI. Patients generally tolerate PBI well, experiencing less noticeable changes in breast appearance and feel. This suggests that PBI is not only effective but also gentler on the body regarding side effects.

Overall, PBI appears to be a promising and safer alternative to full breast radiation, making it an attractive option for eligible patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Partial Breast Irradiation (PBI) is unique because it targets only the part of the breast affected by cancer, unlike traditional whole-breast radiation therapy which treats the entire breast. This approach aims to minimize exposure to healthy tissue and potentially reduce side effects, making the treatment experience better for patients. Researchers are excited about PBI because it could offer a quicker treatment option, potentially completing radiation therapy in a shorter time frame, which is a significant advantage for patients balancing cancer treatment with daily life.

What evidence suggests that Partial Breast Irradiation might be an effective treatment for breast cancer?

Research has shown that partial breast irradiation (PBI) can be as effective as whole breast irradiation (WBI) for treating early-stage breast cancer. Several studies have demonstrated that PBI achieves similar long-term success in preventing cancer recurrence in the same breast. By targeting only the area where the tumor was removed, PBI can shorten treatment time and may reduce side effects. Some research suggests that PBI might also improve the breast's appearance after treatment compared to WBI. Clinical guidelines, such as those from the American Society for Radiation Oncology, endorse PBI as a suitable option for certain patients with early-stage breast cancer. Participants in this trial will receive PBI with external-beam radiation therapy as part of a Phase II single-arm study. ^{2 6 7 8 9}

Who Is on the Research Team?

Simon Powell, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6378667/

Effectiveness of different accelerated partial breast ... This systematic review was conducted to compare the effectiveness of different accelerated partial breast irradiation (APBI) techniques for the treatment of ...

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.1049704/full

Accelerated partial breast irradiation in early stage ... Accelerated partial breast irradiation (APBI) is increasingly used to treat select patients with early stage breast cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S096097762500476X

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. Shorter schedule (<5 fractions ...

4. breastsurgeons.org breastsurgeons.org/docs/statements/Consensus-Statement-for-Accelerated-Partial-Breast-Irradiation.pdf

Resource Guide on Accelerated Partial Breast Irradiation The APBI-IMRT Florence Trial was a single-center phase III trial comparing WBI to ABPI using intensity-modulated radiation therapy (IMRT) in early-stage breast ...

5. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2023/astro-issues-patient-centered-clinical-guideline-on-partial-breast-irradiation-for-early-stage-invas

ASTRO issues patient-centered clinical guideline on partial ... The American Society for Radiation Oncology (ASTRO) issued today a clinical guideline on partial breast irradiation for patients with early-stage invasive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7856797/

A meta-analysis of the efficacy and safety of accelerated ... Compared to whole breast irradiation, accelerated partial breast irradiation significantly reduced serious (≥ grade 2) early toxicities, ...

7. nature.com nature.com/articles/s41598-025-85342-2

Quality of life in early breast cancer patients after adjuvant ... Accelerated partial breast irradiation (APBI) represents a valid option for adjuvant therapy of selected early breast cancer (BC).

8. practicalradonc.org practicalradonc.org/article/S1879-8500(23)00296-5/fulltext

Partial Breast Irradiation for Patients With Early-Stage ... This guideline provides evidence-based recommendations on appropriate indications and techniques for partial breast irradiation (PBI) for ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6323254/

Accelerated partial breast radiotherapy: a review of the ... Partial breast irradiation demonstrated lower rates of changes in breast appearance and firmness when compared to the control group. Lastly, the awaited NSABP ...