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

Trial Summary

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 data supports the effectiveness of the treatment Accelerated Partial Breast Irradiation (APBI) for breast cancer?

Research shows that Accelerated Partial Breast Irradiation (APBI) can be an effective treatment for early-stage breast cancer, allowing treatment to be completed in a shorter time compared to traditional methods. Studies have found that APBI can provide good cosmetic results and low rates of cancer recurrence, making it a viable option for many women. ^{1 2 3 4 5}

Is 3-Day Partial Breast Radiation safe for humans?

Accelerated Partial Breast Irradiation (APBI), which includes 3-Day Partial Breast Radiation, has been studied for over 12 years and is generally considered safe for women with early-stage breast cancer. Studies have shown good cosmetic outcomes and no significant increase in local recurrence or spread of cancer, suggesting it is a safe option for many patients. ^{1 2 3 4 5}

How is the 3-Day Partial Breast Radiation treatment different from other breast cancer treatments?

The 3-Day Partial Breast Radiation treatment, known as Accelerated Partial Breast Irradiation (APBI), is unique because it targets only the part of the breast affected by cancer and can be completed in just a few days, unlike traditional radiation therapy which usually takes several weeks. This shorter treatment time can make it more convenient for patients and may help more women choose breast-conserving surgery. ^{1 2 3 6 7}

What is the purpose of this trial?

The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.

Research Team

Atif Khan, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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) 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]

References

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

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. [2015]

2. Australia pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation using interstitial high dose rate iridium brachytherapy: Early Australian experience and review of the literature. [2018]

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

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. [2015]

4. 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]

5. 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]

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

Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: toxicity analysis of RTOG 95-17. [2022]

7. Greece pubmed.ncbi.nlm.nih.gov

Once Daily Accelerated Partial Breast Irradiation: Preliminary Results with Helical Tomotherapy®. [2017]