Clinical trial · Interventional
APBI: 27Gy in 5 Fractions for Early Breast Cancer
Accelerated Partial Breast Irradiation Using Five Daily Fractions: A Single Arm, Phase II, Prospective Cohort Study to Examine Cosmetic Outcomes and Toxicity (The ACCEL Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will test the safety of partial breast RT using 27Gy in 5 daily fractions which is expected to be equally tolerated as standard whole breast irradiation (WBI) based on radiobiologic modeling of the fibrosis response of normal tissues but be more convenient and less costly than 3-6 weeks of standard WBI. 274 women will be treated. Rates of fibrosis and cosmesis at 2 years will be compared to data already collected using standard WBI in the Canadian RAPID trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APBI 27Gy in 5 fractions | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Single cohort to receive Accelerated Partial Breast Irradiation (APBI) 27Gy in 5 fractions
- interventionNames
- Radiation: APBI 27Gy in 5 fractions
Primary outcomes (1)
- measure
- Rate of Excellent or Good Global cosmetic score
- timeFrame
- 2 years
- description
- Global cosmetic score assessed by trained observers and patients themselves using the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer rating system for cosmetic assessment; rate of deterioration from Excellent/Good to Fair Poor. This will be augmented by assessment of clinical photographs prior to and at 1 and 2 years after radiation therapy (RT).
Secondary outcomes (3)
- measure
- Breast induration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Female, with new invasive or in-situ ductal carcinoma of the breast * Treated with Breast conserving surgery (BCS) with negative margins * pN0 on sentinel node biopsy or axillary dissection; cN0 if DCIS alone * Maximum pathologic tumor diameter is 3.0 cm (invasive or DCIS) * No clinical or imaging evidence of distant metastases * Age 50 years or older at diagnosis * No contraindications to breast irradiation * Excellent or Good overall cosmetic score at baseline following BCS * Able and willing to provide written informed consent * Available for 2 year follow up at the treating RT centre Exclusion Criteria: * Age \< 50 years at diagnosis * BRCA 1 or 2 pathogenic mutation * Pathologic tumor diameter \>3cm (including DCIS+invasive disease) * Lobular histology alone * Triple negative (ER-, PR-, HER2-) or HER2 overexpressing disease * Margin (other than deep) \<2 mm * Presence of both Grade 3 and lymphatic or vascular invasion * Fair or Poor overall cosmetic score at baseline following BCS * Presence of ipsilateral breast implants * Inability to develop an APBI plan meeting all dosimetry constraints * Unable to start RT within 16 weeks of BCS or 8 weeks of last iv chemotherapy * Unable or unwilling to sign informed consent document or attend for 2-year cosmetic assessment at the treating RT centre * Potential contraindications for breast RT including a confirmed diagnosis of lupus, scleroderma, or pregnancy
References
Publications (1)
- BACKGROUNDOlivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8. PMID 23835717