Accelerated Partial Breast Irradiation for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Men, Pregnancy, Immunocompromised, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

121 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Accelerated External Beam 3-D Conformal Radiotherapy, Intracavitary Brachytherapy, IORT, Stereotactic APBI, Whole Breast Radiotherapy for breast cancer?

Research shows that accelerated partial breast irradiation (APBI), including techniques like 3D conformal radiotherapy (3D-CRT) and intraoperative radiotherapy (IORT), is effective for early-stage breast cancer, offering a promising alternative to whole-breast irradiation with benefits like shorter treatment times and reduced radiation exposure to healthy tissue. ^{1 2 3 4 5}

Is accelerated partial breast irradiation safe for humans?

Research shows that accelerated partial breast irradiation (APBI) techniques, like 3D conformal radiotherapy and multicatheter brachytherapy, have been studied for early-stage breast cancer and are generally safe, with early side effects being manageable. ^{1 2 6 7 8}

How is Accelerated Partial Breast Irradiation different from other breast cancer treatments?

Accelerated Partial Breast Irradiation (APBI) is unique because it targets only the part of the breast where cancer was removed, rather than the whole breast, which can reduce treatment time and potentially lessen side effects. It uses techniques like 3D conformal radiotherapy to precisely deliver radiation, making it a convenient alternative for early-stage breast cancer patients. ^{1 2 4 9 10}

What is the purpose of this trial?

To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.

Research Team

Frederick M. Dirbas

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for women aged 40 or older with invasive ductal carcinoma or ductal carcinoma in situ, choosing lumpectomy over mastectomy. The tumor must be smaller than 2.5 cm with a clear margin of normal tissue around it. It's not for those who are immunocompromised, pregnant, have poorly controlled diabetes, previous malignancies with less than five years survival expectation, certain breast implants, or contraindications to radiotherapy.

Inclusion Criteria

I have chosen lumpectomy over mastectomy for my breast cancer treatment.

My tumor is smaller than 2.5 cm with a clear margin of normal tissue around it.

I am a woman over 40 with a type of breast cancer.

Exclusion Criteria

My cancer was found in lymph nodes during my lumpectomy.

It has been over 12 weeks since my last surgery or chemotherapy.

I have breast implants placed before any cancer treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated partial breast irradiation using various methods over 4 to 5 days

1 week

Follow-up

Participants are monitored for safety, effectiveness, and recurrence of breast cancer

20 years

Treatment Details

Interventions

• Accelerated External Beam 3-D Conformal Radiotherapy
• Intracavitary Brachytherapy
• IORT
• Stereotactic APBI
• Whole Breast Radiotherapy

Trial Overview The study tests if accelerated radiotherapy after lumpectomy is as safe and effective as the standard six-week course. Methods include IORT as a single dose; intracavitary brachytherapy over five days; partial breast 3-D CRT in five days; or stereotactic APBI across four days. Outcomes like treatment complications, cosmetic results, cancer recurrence rates and overall survival will be measured.

Participant Groups

Group I: Accelerated Partial Breast Irradiation Experimental Treatment 5 Interventions

lumpectomy with accelerated partial breast irradiation

Group II: Standard Therapy Active Control 2 Interventions

lumpectomy and whole breast irradiation

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

In a study of 61 early-stage breast cancer patients, three-dimensional conformal radiation therapy (3D-CRT) for accelerated partial-breast irradiation (APBI) effectively covered the planning target volume (PTV) with minimal dose to surrounding healthy tissues, achieving over 93% coverage at the prescribed dose.

The treatment resulted in low mean doses to the ipsilateral lung (1.8 Gy) and heart (0.8 Gy), indicating that 3D-CRT APBI is a safe and noninvasive option that could broaden access to effective breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial dosimetric experience using simple three-dimensional conformal external-beam accelerated partial-breast irradiation. Taghian, AG., Kozak, KR., Doppke, KP., et al.[2007]

In a study of 141 patients with early-stage breast cancer, 3D conformal radiotherapy (3D-CRT) for accelerated partial breast irradiation (APBI) showed a very low 5-year recurrence rate of only 0.9%, indicating strong local control of the disease.

The treatment also resulted in excellent cosmetic outcomes, with 95% of patients reporting good to excellent results after more than 5 years of follow-up, suggesting that 3D-CRT APBI is both effective and preserves breast appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. Horst, KC., Fasola, C., Ikeda, D., et al.[2018]

Accelerated partial breast irradiation (APBI) shows significantly better uniformity and conformity in radiation delivery compared to external beam radiation therapy (EBRT), suggesting it may be more effective in targeting the tumor bed while sparing surrounding healthy tissue.

The study, which analyzed dosimetric parameters in 24 patients with left-sided breast cancer, indicates that APBI could minimize side effects and reduce treatment duration, making it a promising option for breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Of Accelerated Partial Breast Radiation Therapy And External Beam Radiation Therapy By Treatment Planning Indices. Hejazi, P., Tirtash, MJ., Khoshnazar, AK.[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]

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]

References

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

Initial dosimetric experience using simple three-dimensional conformal external-beam accelerated partial-breast irradiation. [2007]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. [2018]

3. Poland pubmed.ncbi.nlm.nih.gov

Frequency of whole breast irradiation (WBRT) after intraoperative radiotherapy (IORT) is strongly influenced by institutional protocol qualification criteria. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison Of Accelerated Partial Breast Radiation Therapy And External Beam Radiation Therapy By Treatment Planning Indices. [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. Ireland pubmed.ncbi.nlm.nih.gov

GEC-ESTRO multicenter phase 3-trial: Accelerated partial breast irradiation with interstitial multicatheter brachytherapy versus external beam whole breast irradiation: Early toxicity and patient compliance. [2022]

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

Early side effects of three-dimensional conformal external beam accelerated partial breast irradiation to a total dose of 40 Gy in one week (a phase II trial). [2011]

8. England pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation using multicatheter brachytherapy for select early-stage breast cancer: local control and toxicity. [2021]

9. 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]

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

Breast conservation therapy utilizing partial breast brachytherapy for early-stage cancer of the breast: a retrospective review from the Saint Luke's Cancer Institute. [2015]