Single-fraction APBI for Early-stage Breast Cancer With Favorable Histological Subtypes (Breast-1F)

Официальное название

Accelerated Partial Breast Irradiation in One Fraction for Patients With Early-stage Disease and Favorable Histological Subtypes (Breast-1F).

Обзор

This is a prospective, randomized, monocentric, non-inferiority interventional clinical study comparing an Accelerated Partial Breast Irradiation (APBI) for the surgical bed of early-stage breast cancer patients with favorable histological subtypes, using stereotactic radiotherapy in a single dose of 15.5 Gy with Simultaneous Integrated Boost (SIB) to 21 Gy (study treatment, delivered in a single fraction) versus multifractionated radiotherapy of 30 Gy in 5 fractions (standard treatment, delivered in 5 fractions).

Подробное описание

The project refers to a study on patients with early-stage breast cancer with pathological Tumor stage (pT) from in situ (pTis) to pT2 up to 3 cm in diameter, and pathological/clinical nodal stage p/cN0, and favorable histology (Luminal A and Luminal B human epidermal growth factor receptor 2 (HER2)-negative subtypes), comparing an APBI treatment delivered with stereotactic radiotherapy to the Planning Target Volume (PTV) of the tumor bed of the breast with a total dose (TD) of 15.5 Gy in one fraction, with simultaneous integrated boost (SIB) to a TD of 21 Gy to the Gross Tumor Volume (GTV) represented by tumor bed, versus 30 Gy in 5 consecutive fractions to the PTV of the tumor bed, according to the standard APBI protocol of the department (Florence protocol).

Вмешательства

• Лучевая терапия Adjuvant single-fraction accelerated partial breast irradiation
  Experimental arm (arm 1-single-fraction APBI) patients will be treated to a total dose (TD) of 15.5 Gy to the PTV with a simultaneous integrated boost (SIB) to a TD of 21 Gy to the tumor bed, while arm 2-five-fractions APBI patients with 30 Gy/ 5 fractions to PTV.

Первичные конечные точки

• Ipsilateral Breast Tumor Recurrence (IBTR) [Срок оценки: 5 years]

Вторичные конечные точки (12)

• Acute toxicity [Срок оценки: 1 month]
• Acute toxicity [Срок оценки: 3 months]
• Late toxicity [Срок оценки: 5 years]
• Local Control [Срок оценки: 5 years]
• Local Relapse-Free Survival (LRFS) [Срок оценки: From the date of radiotherapy end until the date of local relapse, assessed up to 5 years]
• Regional Relapse-Free Survival (RRFS) [Срок оценки: From the date of radiotherapy end until the date of regional relapse, assessed up to 5 years]
• Distant Metastasis-Free Survival (DMFS) [Срок оценки: From the date of radiotherapy end until the date of distant metasis diagnosis, assessed up to 5 years]
• Disease-Free Survival (DFS) [Срок оценки: From the date of radiotherapy end until the date of first, any ( local, regional, distant) relapse, assessed up to 5 years]
• Breast Cancer Specific Survival (BCSS) [Срок оценки: From the date of radiotherapy end until the date of death from breast cancer, assessed up to 5 years]
• Overall Survival (OS) [Срок оценки: From the date of radiotherapy end until the date of death from any cause, assessed up to 5 years]
• Cosmesis [Срок оценки: 5 years]
• Acute toxicity interim analysis [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Histological diagnosis of breast cancer
• Patients aged ≥40 years
• Signed informed consent
• Stage pTis-T2, up to 3 cm in the greatest diameter
• Luminal A and Luminal B HER2-negative histological subtypes
• Negative surgical margins (≥ 0.2 cm)
• Negative lymph nodes at sentinel lymph node biopsy, or alternatively with imaging tests (Positron Emission Tomography (PET)/Computed Tomography (CT) and/or axillary ultrasound, and/or breast Magnetic Resonance Imaging (MRI) with and without contrast), or, in rare cases, where still performed, with axillary dissection
• Clinical M0 (PET/CT and/or bone scintigraphy and/or abdomen-pelvis CT with and without contrast in suspected patients), within the previous 3 months.
• Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) ≤2
• No prior thoracic radiotherapy
• Fertile women using contraception methods initiated during oncological treatment.

Критерии исключения

• Patients aged < 40 years
• Tumors > 3 cm
• Multicentric tumors
• Positive or close surgical margins (<0.2 cm)
• Lobular carcinoma
• Negative hormone receptors
• HER2-positive
• BReast CAncer (BRCA) genes BRCA1 and/or BRCA2 positive (only if known)
• Severe systemic diseases
• Psychiatric or other disorders that may prevent the patient from signing informed consent
• Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder)
• Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome)
• Lymph node disease (N1)
• Evidence of distant metastasis (M1)
• Contraindication to systemic treatment
• Pregnant women
• Non-compliance with the dose limits established in the treatment plan

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS San Raffaele Scientific Institute — Milan

Публикации

• Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989. PMID 12393819
• Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152. PMID 12393820
• Litiere S, Werutsky G, Fentiman IS, Rutgers E, Christiaens MR, Van Limbergen E, Baaijens MH, Bogaerts J, Bartelink H. Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial. Lancet Oncol. 2012 Apr;13(4):412-9. doi: 10.1016/S1470-2045(12)70042-6. Epub 2012 Feb 27. PMID 22373563
• Romestaing P, Lehingue Y, Carrie C, Coquard R, Montbarbon X, Ardiet JM, Mamelle N, Gerard JP. Role of a 10-Gy boost in the conservative treatment of early breast cancer: results of a randomized clinical trial in Lyon, France. J Clin Oncol. 1997 Mar;15(3):963-8. doi: 10.1200/JCO.1997.15.3.963. PMID 9060534
• Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. d PMID 17577015
• Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. PMID 22019144
• START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early brea PMID 18355913
• Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143. PMID 12165639

Идентификаторы

NCT: NCT06946238 · Breast-1F

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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