Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phase I, Phase II.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment for Early Stage Breast Cancer
Overview
This is a phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.
Detailed description
The research plan is conceived in two sections, as follows. (i)The technical study handles the set-up, motion and dosimetric issues of the radioablation technique using CyberKnife system.
(ii)The clinical section is organized in two studies: a phase I dose escalation study to identify the maximum tolerated dose (MTD) delivering 18 Gy, 21 Gy and 24 Gy in single fraction and a phase II study to evaluate the rate of pathological complete response (pCR) when a dose level is chosen according to the results of the previous phase I study.
Study population includes patients affected by cT1-T2 (up to 2.5 cm) cN0, adenocarcinoma of the breast, diagnosed with conventional workup. Surgical tumor removal will be scheduled after 4-8 weeks after radioablation. Whole breast radiation therapy without boost will be performed after surgery.
Interventions
- Radiation Phase I
To establish the recommended dose defined as the maximum tolerated dose (MTD)The dose-limiting toxicity (DLT) is defined as any G3-G4 event according to NCI CTCAE Version 4.03 scale. Dose escalation is designed as a 3+3 rule-based study. Dose escalation will be initiated from a baseline dose of 18 Gy and increased to reach 21 Gy and 24 Gy. The population size includes 18 patients. - Radiation Phase II
The recommended dose from the phase I study is delivered, using Cyberknife in order to evaluate the efficacy measured in terms of pCR rate. The population size includes 61 patients.
Primary outcome measures
- Phase I: Identify the maximum tolerated dose (MTD) [Time frame: time frame:2 weeks]
- Phase II: Evaluate efficacy measured in terms of pCR rate [Time frame: time frame:8 weeks]
Secondary outcome measures (7)
- Incidence of chronic toxicity [Time frame: time frame: 6 months - 3 years]
- Cosmetic outcomes [Time frame: time frame: 1 - 3 years]
- Post surgery complications [Time frame: time frame: within 30 days of surgery]
- Disease free survival [Time frame: time frame: 1- 3 years]
- Local relapse [Time frame: time frame: 1 - 3 years]
- Overall survival [Time frame: time frame: 3 years]
- Breast cancer specific survival [Time frame: time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Histologically proven unifocal adenocarcinoma
- T1-T2
- Tumor size up to 2.5 cm
- cN0
- Age ≥ 18 years old
- Good general condition (ECOG 0-2)
- Planned BCS
- Written informed consent
Exclusion criteria
- Tumor close to skin or chest wall
- Pure non-invasive tumor
- Prior RT to the chest
- Neoadjuvant chemotherapy
- Collagenopathies
- Coagulation or autoimmunitary disorders
- Previous malignancies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- IEO, European Institute of Oncology IRCCS — Milan
Publications
- Zerella MA, Zaffaroni M, Ronci G, Dicuonzo S, Rojas DP, Morra A, Gerardi MA, Fodor C, Rondi E, Vigorito S, Penco S, Sargenti M, Baratella P, Vicini E, Morigi C, Kahler-Ribeiro-Fontana S, Galimberti VE, Gandini S, De Camilli E, Renne G, Cattani F, Veronesi P, Orecchia R, Jereczek-Fossa BA, Leonardi MC. A narrative review for radiation oncologists to implement preoperative partial breast irradiation PMID 37650981
- Zerella MA, Zaffaroni M, Ronci G, Dicuonzo S, Rojas DP, Morra A, Fodor C, Rondi E, Vigorito S, Botta F, Cremonesi M, Garibaldi C, Penco S, Galimberti VE, Intra M, Gandini S, Barberis M, Renne G, Cattani F, Veronesi P, Orecchia R, Jereczek-Fossa BA, Leonardi MC. Single fraction ablative preoperative radiation treatment for early-stage breast cancer: the CRYSTAL study - a phase I/II clinical trial p PMID 35366825
Identifiers
NCT: NCT04679454 · IEO 1308 - AIRC IG-23118