Single-fraction APBI for Early-stage Breast Cancer With Favorable Histological Subtypes (Breast-1F)
Recruiting
N/A
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 40 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 311 (estimated)
- Sponsor
- IRCCS San Raffaele · Other
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About This Trial
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 …
Trial Locations
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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 a…
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