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

Trial Summary

What is the purpose of this trial?

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.

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.

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

Research shows that Accelerated Partial Breast Irradiation (APBI) is effective for early-stage breast cancer, with studies indicating a very low rate of disease recurrence and favorable outcomes in terms of quality of life compared to whole breast irradiation. ^{1 2 3 4 5}

Is accelerated partial breast irradiation (APBI) safe for humans?

Research shows that accelerated partial breast irradiation (APBI) is generally safe for humans, with studies reporting low rates of toxicity and good cosmetic outcomes in patients with early-stage breast cancer. ^{2 4 6 7 8}

How is Accelerated Partial Breast Irradiation (APBI) different from other treatments for early-stage breast cancer?

Accelerated Partial Breast Irradiation (APBI) is unique because it targets only the part of the breast where cancer was removed, using a shorter treatment period compared to whole breast irradiation (WBI). This approach can improve patient convenience and reduce costs, while maintaining similar effectiveness and potentially causing fewer side effects. ^{1 2 4 8 9}

Research Team

Charles Leonard, MD

Principal Investigator

Rocky Mountain Cancer Centers

Eligibility Criteria

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.

I need a breast MRI to confirm my cancer is localized due to its specific type.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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 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 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]

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]

References

1. England 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. [2022]

2. England 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. [2022]

3. 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]

4. China 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]. [2013]

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

Five-Fraction Prone Accelerated Partial Breast Irradiation: Long-Term Oncologic, Dosimetric, and Cosmetic Outcome. [2022]

6. 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]

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

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

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation with intensity-modulated radiotherapy is feasible for chinese breast cancer patients. [2021]

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

Accelerated Partial Breast Irradiation (APBI): Where Are We Now? [2022]