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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a faster and potentially safer way to deliver radiation therapy to breast cancer patients. It examines methods that target only the area around the removed tumor (lumpectomy site) instead of the whole breast, aiming to determine if these methods are as effective as the traditional six-week radiation course. The study evaluates how these treatments impact recovery, appearance, cancer recurrence, and overall survival. Women who have chosen lumpectomy over mastectomy and have a small tumor (less than 2.5 cm) may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may improve future breast cancer treatments.

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 prior data suggests that these radiotherapy techniques are safe for breast cancer treatment?

Research shows that accelerated partial breast irradiation (APBI) is generally easy for patients to handle. In one study, 95% of patients found APBI using 3D conformal external beam radiotherapy acceptable, indicating it is quite manageable. Another study on different APBI methods suggested they could serve as alternatives to traditional whole breast radiation, which usually takes more time.

The studies did not report any major side effects, suggesting that any side effects are not severe. However, like any treatment, some mild side effects might occur, such as skin irritation or tiredness. Overall, the evidence suggests that APBI is a safe option for many patients.

Prospective trial participants should consult their healthcare provider to determine how this treatment might fit into their personal health plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Accelerated Partial Breast Irradiation (APBI) for breast cancer because it offers a more focused and faster approach than traditional treatments. Unlike standard whole breast irradiation, which targets the entire breast and requires several weeks of treatment, APBI directs radiation only to the part of the breast where the cancer was removed and can be completed in a much shorter timeframe. This precision not only reduces the treatment duration but also minimizes exposure to healthy tissues, potentially leading to fewer side effects and a better quality of life for patients.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare accelerated partial breast irradiation (APBI) with standard whole breast irradiation for early-stage breast cancer. Studies have shown that APBI is a promising treatment. Research indicates that using 3D conformal external beam radiotherapy (3D-CRT) in APBI provides good tumor control and safety, similar to traditional treatments. In a seven-year study, patients who received APBI had outcomes comparable to those who underwent whole breast radiation, but with fewer side effects. Another study found that 95% of patients were satisfied with APBI, suggesting it could be a convenient alternative. These findings suggest that APBI might be an effective and less demanding option for breast cancer patients. ^{1 4 5 6 7}

Who Is on the Research Team?

Frederick M. Dirbas

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7648201/

Accelerated partial breast irradiation with 3-dimensional ... 7-year results of APBI with 3D-CRT and IG-IMRT are encouraging. Toxicity profile and local tumor control are comparable to other series using multicatheter ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3365530/

INITIAL EFFICACY RESULTS OF RTOG 0319: THREE ... This prospective study (Radiation Therapy Oncology Group 0319) examines the use of three-dimensional conformal external beam radiotherapy (3D-CRT) to deliver ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960977616300753

Five-year results of a prospective clinical trial investigating ... This study presents the results of a prospective trial evaluating 3-dimensional conformal radiotherapy (3D-CRT) to deliver APBI for early-stage breast cancer.

4. redjournal.org redjournal.org/article/S0360-3016(11)01268-5/pdf

3D-CRT for Accelerated Partial Breast Irradiation (APBI) Conclusions: The present study shows that APBI using 3D conformal external beam radiotherapy is well accepted by most of breast cancer patients (.95% of ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6411019/

External Beam Accelerated Partial Breast Irradiation The aim of the study was to evaluate and compare four different external beam radiotherapy techniques of accelerated partial breast irradiation (APBI)

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842811000333

Accelerated partial breast irradiation using external beam ... This paper reviews external beam conformal radiation therapy (EBCRT) as a possible technique to APBI. The various EBCRT approaches such as 3D conformal ...