Targeted Radiation Therapy for Breast Cancer

(Second Chance Trial)

Recruiting at 2 trial locations

Overseen By Charles Ekeh, M.D

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Regional recurrences, Metastatic disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it mentions that every kind of systemic therapy is allowed. This suggests you may be able to continue your current treatments.

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

Research shows that Accelerated Partial Breast Irradiation (APBI) is effective for early-stage breast cancer, offering a shorter treatment time compared to whole breast irradiation (WBI) and maintaining similar outcomes in terms of cancer control and recurrence rates. ^{1 2 3 4 5}

Is targeted radiation therapy for breast cancer safe?

Research on targeted radiation therapy, like accelerated partial breast irradiation (APBI), shows it is generally well-tolerated with manageable side effects. Studies report good results in terms of safety, with low levels of local toxicity (harm to the treated area) and satisfactory cosmetic outcomes. ^{5 6 7 8 9}

How is the treatment Partial Breast Irradiation (PBI) different from other breast cancer treatments?

Partial Breast Irradiation (PBI) is unique because it targets only the part of the breast where the cancer was removed, rather than the whole breast, and it is delivered over a shorter period of time. This approach aims to reduce unnecessary radiation exposure and treatment duration compared to conventional whole breast irradiation. ^{2 5 10 11 12}

Research Team

John Ng, M.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for adults who've had breast cancer return in the same breast after lumpectomy and radiation. They should have a small, single tumor (less than 2-3 cm) without skin involvement or distant spread, up to three positive lymph nodes, clear margins from surgery, and it must be at least a year since their first treatment.

Inclusion Criteria

I have up to 3 lymph nodes with cancer but no spread beyond their capsule.

Informed consent for clinical and research purposes signed

My cancer has not spread to distant parts of my body.

Exclusion Criteria

I have had targeted radiation therapy for breast cancer.

Positive histologic margins at resection

I am unhappy with how my previous surgery and radiation therapy look.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive partial breast irradiation with 30 Gy in 5 fractions over 1-2 weeks

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking of adverse events and quality of life assessments

60 months

Regular visits at 6, 12, 24, 36, 48, and 60 months

Treatment Details

Interventions

• Partial Breast Irradiation

Trial Overview The study tests partial breast irradiation focused on the surgical bed with some margin around it. The aim is to see if this can offer another chance at preserving the breast in patients who've had previous lumpectomy and radiotherapy but now face recurrence.

Participant Groups

Group I: Radiation Therapy Experimental Treatment 1 Intervention

Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT).

Partial Breast Irradiation is already approved in United States, European Union 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)

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

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]

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 98 patients with early-stage breast cancer treated with accelerated partial breast irradiation (APBI), the 5-year rate of ipsilateral breast tumor recurrence (IBTR) was low at 5%, indicating the treatment's efficacy, especially for estrogen receptor-positive tumors.

Patients with triple-negative breast cancer had a significantly higher IBTR rate of 33% compared to only 2% for non-triple-negative patients, suggesting that hormone receptor status is an important factor in treatment outcomes with 3D-APBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study. Pashtan, IM., Recht, A., Ancukiewicz, M., et al.[2022]

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 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) shows early results indicating comparable toxicity, cosmetic outcomes, and local control to standard whole-breast irradiation, based on phase I-II studies involving around 500 patients.

Approximately 3% of patients experience local recurrence after breast-conserving surgery, whether or not they receive standard whole-breast irradiation, highlighting the need for further research to validate APBI as a viable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation after conservative surgery for breast cancer. Kuerer, HM., Julian, TB., Strom, EA., et al.[2019]

In a study of 127 women with early-stage breast cancer treated with accelerated partial breast irradiation (APBI), the treatment showed excellent disease-free survival at 3 years, with a 97% rate and only one local recurrence.

Most treatment-related toxicities were mild (Grade 1), with acceptable cosmetic outcomes, as 82% of women reported good to excellent cosmesis at the 3-year follow-up, supporting the safety and efficacy of APBI for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year outcomes of a Canadian multicenter study of accelerated partial breast irradiation using conformal radiation therapy. Berrang, TS., Olivotto, I., Kim, DH., 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]

Accelerated partial breast irradiation (APBI) offers a promising alternative to whole breast irradiation for selected low-risk breast cancer patients, potentially reducing the volume of breast tissue exposed to radiation and shortening treatment duration.

Stereotactic partial breast radiotherapy has shown preliminary benefits in terms of reduced invasiveness, local toxicity, and improved cosmetic outcomes, supported by advanced imaging and planning techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic partial breast irradiation in primary breast cancer: A comprehensive review of the current status and future directions. Takanen, S., Pinnarò, P., Farina, I., et al.[2022]

Accelerated partial breast irradiation (APBI) is a promising adjuvant radiotherapy strategy for early breast cancer patients post-surgery, focusing on the tumor bed to reduce treatment duration and minimize late radiation side effects.

The review emphasizes the importance of careful patient selection for APBI based on tumor characteristics and recurrence patterns, supported by evidence from previous studies, to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation as part of breast conserving therapy of early breast carcinoma: a systematic review. Offersen, BV., Overgaard, M., Kroman, N., et al.[2022]

Breast conserving surgery combined with radiation therapy, particularly partial-breast irradiation (PBI) and accelerated partial-breast irradiation (APBI), is gaining acceptance as a viable alternative to mastectomy for early-stage breast cancer, focusing on treating only high-risk areas.

Despite emerging data on the effectiveness of PBI and APBI over 5 to 7 years, key issues such as patient selection, radiation dosing, and overall survival outcomes still need to be addressed through further research and standardized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Workshop on partial breast irradiation: state of the art and the science, Bethesda, MD, December 8-10, 2002. Wallner, P., Arthur, D., Bartelink, H., et al.[2019]

A case-control study comparing accelerated partial-breast irradiation (APBI) and conventional whole breast radiotherapy (WBRT) found no significant differences in overall survival or disease-free survival between the two treatments for early breast cancer.

APBI resulted in better cosmetic outcomes compared to WBRT, although it was associated with a slight increase in mild breast fibrosis and telangiectasias, indicating a trade-off between cosmetic benefits and some adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial-breast irradiation vs conventional whole-breast radiotherapy in early breast cancer: a case-control study of disease control, cosmesis, and complications. Wadasadawala, T., Sarin, R., Budrukkar, A., et al.[2022]

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

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

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

External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study. [2022]

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

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

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

Accelerated partial breast irradiation after conservative surgery for breast cancer. [2019]

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

Three-year outcomes of a Canadian multicenter study of accelerated partial breast irradiation using conformal radiation therapy. [2018]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic partial breast irradiation in primary breast cancer: A comprehensive review of the current status and future directions. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation as part of breast conserving therapy of early breast carcinoma: a systematic review. [2022]

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

Workshop on partial breast irradiation: state of the art and the science, Bethesda, MD, December 8-10, 2002. [2019]

12. India pubmed.ncbi.nlm.nih.gov

Accelerated partial-breast irradiation vs conventional whole-breast radiotherapy in early breast cancer: a case-control study of disease control, cosmesis, and complications. [2022]