3-Day Partial Breast Radiation for Breast Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen by Atif Khan, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Metastasis, Pregnancy, Multicentric disease, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

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.

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}

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.

Trial 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 (Radiation Therapy)

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 Canada for the following indications:

Approved in Canada as APBI for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memoral Sloan Kettering Monmouth Middletown, NJ

Memoral Sloan Kettering Basking Ridge Basking Ridge, NJ

Memoral Sloan Kettering Westchester Harrison, NY

Memorial Sloan Kettering Westchester Harrison, NY

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1998

Patients Recruited

602,000+

Findings from Research

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]

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]

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]

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]

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]

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]