3-Day Partial Breast Radiation for Breast Cancer

Recruiting at 11 trial locations

Overseen By Simon Powell, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Metastasis, Pregnancy, Multicentric disease, 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: Unknown

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to breast cancer treatment using a faster, 3-day radiation therapy called Accelerated Partial Breast Irradiation (APBI). The goal is to determine if it is safe and can effectively treat cancer with minimal side effects. The trial targets women who have undergone a lumpectomy and have a specific type and size of breast cancer or DCIS (ductal carcinoma in situ). Suitable candidates are those who recently had a lumpectomy for a small, single-area breast cancer that hasn't spread. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not require you to stop taking hormonal therapies like tamoxifen or anti-Her2 therapies such as trastuzumab. However, other anti-cancer treatments should be completed at least 2 weeks before starting the trial.

What prior data suggests that Accelerated Partial Breast Irradiation is safe for women with breast cancer?

Research has shown that accelerated partial breast irradiation (APBI) is generally manageable for patients with early breast cancer. Studies indicate that APBI can reduce the risk of serious side effects compared to whole-breast radiation. Specifically, a review of several studies found that APBI led to fewer severe side effects, which are more harmful or uncomfortable. Additionally, patients who received APBI reported a quality of life similar to those who underwent traditional radiation treatments.

In summary, APBI is considered a safe option with mild side effects for many patients, making it a promising treatment for early-stage breast cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Accelerated Partial Breast Irradiation (APBI) is unique because it offers a shorter treatment duration compared to the traditional whole breast radiation therapy, which usually takes several weeks. This treatment is designed to target only the part of the breast affected by cancer, potentially reducing side effects that are more common with whole breast radiation. Researchers are excited about APBI because it may allow patients to complete their radiation therapy in just three days, significantly improving convenience and quality of life for those undergoing treatment for early-stage breast cancer.

What evidence suggests that Accelerated Partial Breast Irradiation is effective for breast cancer?

Studies have shown that Accelerated Partial Breast Irradiation (APBI) effectively treats breast cancer. Specifically, for patients with ductal carcinoma in situ (DCIS) who underwent a lumpectomy, APBI prevented cancer recurrence in the same area for 99.4% of patients over two years. Other research indicates that APBI supports excellent survival rates and good cosmetic outcomes. This trial will evaluate APBI, which targets radiation only at the cancer-affected part of the breast, potentially reducing side effects compared to whole-breast irradiation. ^{6 7 8 9 10}

Who Is on the Research Team?

Atif Khan, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for women aged 45 or older with early-stage breast cancer (stage I) or DCIS, who have had a lumpectomy. They must not be pregnant, breastfeeding, or at high risk of pregnancy without using contraception. Women under 70 with certain types of small tumors and no severe lymph invasion are eligible. Those with distant metastasis, prior chest radiation, active second malignancy other than non-melanoma skin cancers, or on investigational drugs are excluded.

Inclusion Criteria

I am fully active or can carry out light work.

My breast cancer surgery showed signs of cancer in the lymph vessels.

My breast cancer is of the invasive lobular type.

Exclusion Criteria

I do not have uncontrolled infections, diabetes, or connective tissue diseases that would make treatment risky.

I am not currently on any experimental treatments.

The cancer has spread beyond the edges of the main tumor and makes up at least 25% of the tumor area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive a 3-day partial breast radiation therapy

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Partial Breast Irradiation

Trial Overview The study tests if a concentrated dose of radiation therapy over three days is effective and safe for women after lumpectomy for breast cancer/DCIS. It aims to see if this shorter treatment period results in few or mild side effects compared to traditional longer treatments.

How Is the Trial Designed?

Group I: Participants with Breast Cancer Experimental Treatment 1 Intervention

Participants will have unicentric pathological stage I invasive ductal breast cancer or Grade 1 or 2 DCIS measuring \<3cm in longest diameter on pathology and/or mammogram that is histologically confirmed at MSKCC.

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

Approved in United States as APBI for:

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

Approved in European Union as APBI for:

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

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?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a pilot program of accelerated partial breast irradiation (APBI) involving seven women with early-stage breast cancer, patients were followed for an average of 42.7 months, showing promising results.

The treatment resulted in good to excellent cosmetic outcomes, with no cases of loco-regional relapse or systemic metastases reported, indicating its potential efficacy and safety for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation using interstitial high dose rate iridium brachytherapy: Early Australian experience and review of the literature. Stevens, MJ., Cooper, SG., Cross, P., et al.[2018]

Accelerated Partial Breast Irradiation (APBI) offers a promising alternative to conventional six-week radiotherapy, allowing women with early-stage breast cancer to complete treatment in just five days, which may increase access to breast conservation options.

Successful outcomes with APBI depend heavily on careful patient selection and quality assurance in brachytherapy, highlighting the importance of these factors in ensuring effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. Arthur, DW., Vicini, FA., Kuske, RR., et al.[2015]

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) offers a promising alternative to traditional six-week radiotherapy, allowing women with early-stage breast cancer to complete treatment in just five days, potentially increasing access to breast conservation options.

Successful outcomes with APBI depend heavily on careful patient selection and quality assurance in brachytherapy, highlighting the importance of these factors in ensuring effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. Arthur, DW., Vicini, FA., Kuske, RR., et al.[2015]

Accelerated partial breast irradiation (APBI) using either low-dose-rate (LDR) or high-dose-rate (HDR) techniques showed modest and acceptable toxicity rates in a study of 99 women, with only 3% of HDR patients experiencing severe toxicity compared to 9% in the LDR group.

The study indicates that while APBI is effective in reducing treatment time to 4-5 days compared to conventional methods, patients receiving chemotherapy had a higher rate of Grade 3 toxicity, highlighting the need for careful monitoring in such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: toxicity analysis of RTOG 95-17. Kuske, RR., Winter, K., Arthur, DW., et al.[2022]

In a study involving 111 patients with low-risk breast cancer, once-daily accelerated partial breast irradiation (APBI) using TomoTherapy showed no cases of ipsilateral breast recurrence after a median follow-up of 34 months, indicating effective local control.

The cosmetic outcomes were largely positive, with only 1-4% of patients rating their results as fair or poor, suggesting that this treatment approach does not compromise aesthetic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once Daily Accelerated Partial Breast Irradiation: Preliminary Results with Helical Tomotherapy®. DE Paula, U., D'Angelillo, RM., Barbara, R., et al.[2017]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820925002915

Accelerated Partial Breast Irradiation (APBI) For Ductal ... Accelerated partial breast irradiation (APBI) achieved excellent local control (2-year rate: 99.4%) in patients with DCIS following lumpectomy, ...

2. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00079-X/fulltext

Long-Term Outcomes of Multimodality Accelerated Partial ... APBI as a component of breast-conserving therapy for pure ductal carcinoma in situ is associated with excellent survival rates, local control, and cosmetic ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30474504/

long-term follow-up from a phase 3 randomized trial Conclusions: Waiting for pending studies and mature follow-up, we confirmed the efficacy and safety of APBI for low-risk DCIS. Keywords: Breast cancer; ductal ...

4. 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 ...

5. abs.amegroups.org abs.amegroups.org/article/view/6912/html

Accelerated partial breast irradiation: current status and future ... APBI has been studied in a number of clinical trials as an alternative to whole breast irradiation in women with early-stage breast cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11212331/

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.

7. 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 ...

8. 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, ...

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

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 ...

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

Resource Guide on Accelerated Partial Breast Irradiation APBI has been studied as an alternative to whole breast radiation to potentially increase the number of individuals eligible for breast conservation. APBI can ...