IMRT vs. APBI for Early Stage Breast Cancer

(2009-APBI Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Charles Leonard, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Rocky Mountain Cancer Centers

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Rocky Mountain Cancer Centers - Thornton Thornton, CO

Rocky Mountain Cancer Centers - Littleton Littleton, CO

Rocky Mountain Cancer Centers - Aurora Aurora, CO

Rocky Mountain Cancer Centers - Lakewood Lakewood, CO

More Trial Locations

Who Is Running the Clinical Trial?

Rocky Mountain Cancer Centers Lead Sponsor

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] Accelerated partial breast irradiation (APBI) has been introduced as an alternative treatment method for selected patients with early stage breast cancer (BC). Intensity-modulated radiotherapy (IMRT) has the theoretical advantage of a further increase in dose conformity compared with three-dimensional techniques, with more normal tissue sparing. The aim of this randomised trial is to compare the local recurrence and survival of APBI using the IMRT technique after breast-conserving surgery to conventional whole-breast irradiation (WBI) in early stage BC.

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] Accelerated partial breast irradiation (APBI) represents a valid option for selected early breast cancer (BC). We recently published the 5-year results of the APBI-IMRT-Florence phase 3 randomised trial (NCT02104895), showing a very low rate of disease failure, with acute and early-late toxicity in favour of APBI. We present the early and 2-year follow-up health-related quality of life (HRQoL) results.

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] Accelerated partial breast irradiation (APBI) is the strategy that allows adjuvant treatment delivery in a shorter period of time in smaller volumes. This study was undertaken to assess the effectiveness and outcomes of APBI in breast cancer compared with whole-breast irradiation (WBI).

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] To explore the clinical feasibility of accelerated partial breast irradiation (APBI) by intensity-modulated radiotherapy (IMRT).

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

Five-Fraction Prone Accelerated Partial Breast Irradiation: Long-Term Oncologic, Dosimetric, and Cosmetic Outcome. [2022] Randomized data support accelerated partial breast irradiation (APBI) for early-stage breast cancer with variable techniques and cosmesis outcomes. We have treated patients with 5-fraction prone external beam APBI for over a decade and herein report acute and late outcomes.

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] To report 3-year toxicity, cosmesis, and efficacy of a multicenter study of external beam, accelerated partial breast irradiation (APBI) for early-stage breast cancer.

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

Accelerated Partial Breast Irradiation: Association of Dosimetric Parameters With Patient-Reported Outcomes. [2023] Accelerated partial breast irradiation (APBI) after breast-conserving surgery offers a well-tolerated adjuvant radiation therapy option for patients with breast cancer. We sought to describe patient-reported acute toxicity as a function of salient dosimetric parameters during and after an APBI regimen of 40 Gy in 10 once-daily fractions.

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

Accelerated partial breast irradiation with intensity-modulated radiotherapy is feasible for chinese breast cancer patients. [2021] Several accelerated partial breast irradiation (APBI) techniques are being investigated in patients with early-stage breast cancer. The present study evaluated the feasibility, early toxicity, initial efficacy, and cosmetic outcomes of accelerated partial breast intensity-modulated radiotherapy (IMRT) for Chinese female patients with early-stage breast cancer after breast-conserving surgery.

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

Accelerated Partial Breast Irradiation (APBI): Where Are We Now? [2022] Accelerated partial breast irradiation (APBI) is an alternative approach to breast conserving therapy (BCT) where radiation (RT) is delivered over a shorter period of time compared with whole breast irradiation (WBI), resulting in improved patient convenience and cost savings. APBI can be delivered using brachytherapy, intraoperative RT, or conformal external beam radiation therapy (EBRT) techniques. In this review, the authors appraise the latest modern randomized controlled trials (RCTs) of APBI and discuss the application of the data to clinical practice.