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

NCT ID: NCT06946238

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2035-06-30

Brief Summary

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).

Detailed Description

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1- Single-fraction APBI

Patients in the study (randomized to arm 1) will be treated with a total dose (TD) of 15.5 Gy to the Planning Tumor Volume (PTV) with simultaneous integrated boost (SIB) to a TD of 21 Gy to the tumor bed. For each patient, a stereotactic radiotherapy treatment plan will be created to ensure adequate coverage of the treatment volumes and the tolerability of the Organs At Risk (OAR). Specific, already validated dose-volume constraints will be applied for the evaluation of OARs. The dose-volume histogram (DVH) for the Gross Tumor Volume (GTV), Clinical Target Volume (CTV), PTV, and OAR will be calculated in order to achieve the best optimization in terms of tolerability and efficacy.

Group Type: EXPERIMENTAL

Adjuvant single-fraction accelerated partial breast irradiation

Intervention Type: RADIATION

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.

Arm 2- Five-fractions APBI

Patients randomized to arm 2 will be treated according to the standard APBI protocol of our department (Florence protocol), delivering a TD of 30 Gy in 5 fractions to the tumor bed.

Group Type: ACTIVE_COMPARATOR

Adjuvant single-fraction accelerated partial breast irradiation

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

Ultrahypofractionated Radiotherapy

Eligibility Criteria

Inclusion Criteria

1. Histological diagnosis of breast cancer

2. Patients aged ≥40 years

3. Signed informed consent

4. Stage pTis-T2, up to 3 cm in the greatest diameter

5. Luminal A and Luminal B HER2-negative histological subtypes

6. Negative surgical margins (≥ 0.2 cm)

7. 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

8. 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.

9. Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) ≤2

10. No prior thoracic radiotherapy

11. Fertile women using contraception methods initiated during oncological treatment.

Exclusion Criteria

1. Patients aged < 40 years

2. Tumors > 3 cm

3. Multicentric tumors

4. Positive or close surgical margins (<0.2 cm)

5. Lobular carcinoma

6. Negative hormone receptors

7. HER2-positive

8. BReast CAncer (BRCA) genes BRCA1 and/or BRCA2 positive (only if known)

9. Severe systemic diseases

10. Psychiatric or other disorders that may prevent the patient from signing informed consent

11. 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)

12. Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome)

13. Lymph node disease (N1)

14. Evidence of distant metastasis (M1)

15. Contraindication to systemic treatment

16. Pregnant women

17. Non-compliance with the dose limits established in the treatment plan

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Andrei Fodor, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrei Fodor, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele Scientific Institute

Locations

IRCCS San Raffaele Scientific Institute

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Andrei Fodor, MD

Role: CONTACT

fodor.andrei@hsr.it

+390226437634

Nadia G Di Muzio, Prof

Role: CONTACT

dimuzio.nadia@hsr.it

+390226437643

Facility Contacts

Andrei Fodor, MD

Role: primary

fodor.andrei@hsr.it

+390226437634

Roberta G Tummineri, MD

Role: backup

tummineri.roberta@hsr.it

+390226435452

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Other Identifiers

Breast-1F

Identifier Type: -

Identifier Source: org_study_id