IMRT vs. APBI for Early Stage Breast Cancer

(2009-APBI Trial)

Recruiting at 4 trial locations

Overseen By Rachel Lei, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rocky Mountain Cancer Centers

Disqualifiers: Pregnancy, Breast-feeding, Collagen-vascular, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

660 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of radiation therapy for individuals with early-stage breast cancer. Researchers compare intensity modulated radiotherapy (IMRT) to the standard method, 3D-conformal radiotherapy (3D-CRT). The trial aims to determine if IMRT is safer for healthy breast and lung tissue and if it leads to better outcomes. Suitable candidates have early-stage breast cancer confirmed as small and localized, with no cancer spread, and have already undergone surgery to remove the tumor. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that accelerated partial breast irradiation (APBI) is generally safe for patients with early-stage breast cancer. Studies have found that over 75% of patients are satisfied with the appearance of their breast after treatment, indicating less harm to nearby tissue.

One study found that patients who received APBI had a low chance of cancer recurrence in the same area, with no cancer spreading to other parts of the body over four years. This suggests the treatment is effective and safe.

Additionally, a meta-analysis, which combines results from several studies, found that APBI has similar safety outcomes to whole-breast irradiation, a more traditional treatment, suggesting it is likely to be well-tolerated.

Overall, APBI appears to be a safe choice for early-stage breast cancer patients, with most experiencing good results and a low risk of cancer returning. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Intensity Modulated Radiotherapy (IMRT) and Three Dimensional Conformal Radiotherapy (3D-CRT) for early-stage breast cancer because these techniques could offer a more precise approach to delivering radiation. Unlike traditional whole-breast irradiation, these methods target only the part of the breast where cancer is most likely to return, potentially reducing exposure to healthy tissue and minimizing side effects. Both IMRT and 3D-CRT deliver the same dosage of radiation, 38.5 Gy, over just five days, which is much quicker than the typical weeks-long schedule. This accelerated treatment could lead to more convenient and less disruptive care for patients.

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

This trial will compare Intensity Modulated Radiotherapy (IMRT) with Accelerated Partial Breast Irradiation (APBI) for early-stage breast cancer. Research has shown that APBI can effectively treat early-stage breast cancer. The Florence trial found that APBI led to fewer short-term and long-term side effects and better cosmetic results compared to traditional methods, based on data collected over ten years. Studies also indicate that APBI offers similar long-term results as whole breast radiotherapy but with a shorter treatment time. Additionally, patients who received APBI reported a quality of life that was not worse than with other radiation therapies. These findings support the potential effectiveness of APBI in treating early-stage breast cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

Charles Leonard, MD

Principal Investigator

Rocky Mountain Cancer Centers

Are You a Good Fit for This Trial?

This trial is for early stage breast cancer patients who've had a lumpectomy with clear margins and no widespread disease. They must start radiotherapy within 10 weeks post-surgery, have localized disease confirmed by MRI, and be willing to follow the study's protocol.

Inclusion Criteria

I had an MRI before my lumpectomy for DCIS.

I am scheduled for radiotherapy within 10 weeks after my breast surgery.

My cancer is small and confined, measuring 3.0 cm or less.

Exclusion Criteria

Pregnancy or breast-feeding.

My cancer has multiple visible tumors larger than 3.0 cm.

My last surgery didn’t remove all the cancer, leaving some very close to the edge of what was taken out.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive either intensity modulated radiotherapy (IMRT) or 3D-conformal radiotherapy (3D-CRT), 38.5 Gy in 10 fractions over 5 days

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of breast pain, cosmetic outcomes, and survival

5-15 years

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Partial Breast Irradiation

Trial Overview

The trial compares two types of radiation therapy after lumpectomy: Intensity Modulated Radiotherapy (IMRT) versus standard 3D-conformal Accelerated Partial Breast Irradiation (APBI). It aims to see if IMRT better spares healthy tissue and improves outcomes.

How Is the Trial Designed?

Group I: IMRT Experimental Treatment 1 Intervention

Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days

Group II: 3D-CRT Active Control 1 Intervention

Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days

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?

Rocky Mountain Cancer Centers

Lead Sponsor

Trials

8

Recruited

1,500+

Published Research Related to This Trial

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 intensity-modulated radiotherapy (APBI-IMRT) is feasible and shows good initial efficacy for Chinese female patients with early-stage breast cancer after breast-conserving surgery, with no local recurrence or distant metastasis observed over a median follow-up of 53 months.

The treatment resulted in acceptable levels of acute and late toxicities, with 96.8% of patients achieving fine or excellent cosmetic outcomes, indicating that APBI-IMRT is a safe option with favorable cosmetic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation with intensity-modulated radiotherapy is feasible for chinese breast cancer patients. He, Z., Wu, S., Zhou, J., et al.[2021]

In a phase 3 trial involving 520 women with early breast cancer, accelerated partial breast irradiation (APBI) demonstrated significantly better health-related quality of life (HRQoL) outcomes compared to standard whole breast irradiation (WBI) at both 1 and 2 years post-treatment.

Patients receiving APBI reported improved global health status and better scores in body image perception and symptoms related to breast and arm, suggesting that APBI is a favorable treatment option for selected low-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation using intensity modulated radiotherapy versus whole breast irradiation: Health-related quality of life final analysis from the Florence phase 3 trial. Meattini, I., Saieva, C., Miccinesi, G., et al.[2022]

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) using intensity-modulated radiotherapy (IMRT) was successfully administered to 26 patients with early-stage breast cancer, with all patients completing the treatment and experiencing only mild acute skin reactions (Grade 1).

The study reported a 100% disease-free survival rate at 3 years post-treatment, with good to excellent cosmetic outcomes, indicating that IMRT is a safe and effective option for localized breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical observation of accelerated partial-breast intensity-modulated radiotherapy in patients with early-stage breast cancer after breast-conserving surgery]. Li, YH., Tie, J., Wu, H., et al.[2013]

In a study of 331 patients treated with 5-fraction prone accelerated partial breast irradiation (APBI), the 5-year local recurrence-free survival rate was an impressive 99.5%, indicating high efficacy in preventing cancer recurrence.

The treatment resulted in low rates of acute side effects, with no grade 3 toxicity reported, and high patient satisfaction regarding cosmetic outcomes, with 89.4% rating their results as good to excellent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Fraction Prone Accelerated Partial Breast Irradiation: Long-Term Oncologic, Dosimetric, and Cosmetic Outcome. Shah, BA., Xiao, J., Oh, C., et al.[2022]

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 520 women with early-stage breast cancer, accelerated partial breast irradiation (APBI) using intensity-modulated radiotherapy (IMRT) showed a similar rate of local tumor recurrence compared to conventional whole-breast irradiation (WBI), with both groups having an ipsilateral breast tumor recurrence (IBTR) rate of 1.5%.

APBI demonstrated a significantly better toxicity profile, with fewer acute and late side effects and improved cosmetic outcomes, while also showing a higher overall survival rate of 99.4% compared to 96.6% for the WBI group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Livi, L., Meattini, I., Marrazzo, L., et al.[2022]

Accelerated partial breast irradiation (APBI) has been shown to be non-inferior to whole breast irradiation (WBI) in terms of long-term outcomes, with similar rates of ipsilateral breast tumor recurrence (IBTR) at 8 years (3% for APBI vs. 2.8% for WBI), based on the OCOG-RAPID trial involving patients receiving 38.5 Gy in 10 fractions.

While APBI offers reduced acute toxicity and improved convenience, it may lead to worse late toxicity and breast cosmetic outcomes compared to WBI, indicating that patient selection is crucial for its application, particularly for those with low-risk ductal carcinoma in situ or early-stage invasive ductal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Partial Breast Irradiation (APBI): Where Are We Now? Goldberg, M., Whelan, TJ.[2022]

Citations

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However, the Barcelona trial using 3D-CRT and similar fractionation to the RAPID trial showed > 75% of patients in the APBI arm had excellent or good cosmesis ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301624035144

Accelerated Partial Breast Irradiation for Early-Stage ...

Among patients with ILC who received APBI after breast conserving surgery, we observed a 4-year LR rate of 3%. No regional or distant recurrences were observed, ...

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