Clinical trial NCT04679454: Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer
Official title: Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment for Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: preoperative radiotherapy
radiosurgery
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Phase I: Identify the maximum tolerated dose (MTD)
timeFrame: time frame:2 weeks
measure: Phase II: Evaluate efficacy measured in terms of pCR rate
timeFrame: time frame:8 weeks
Secondary outcomes:
measure: Incidence of chronic toxicity
timeFrame: time frame: 6 months - 3 years
measure: Cosmetic outcomes
timeFrame: time frame: 1 - 3 years
measure: Post surgery complications
timeFrame: time frame: within 30 days of surgery
measure: Disease free survival
timeFrame: time frame: 1- 3 years
measure: Local relapse
timeFrame: time frame: 1 - 3 years
measure: Overall survival
timeFrame: time frame: 3 years
measure: Breast cancer specific survival
timeFrame: time frame: 3 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IEO, European Institute of Oncology IRCCS
Study officials:
affiliation: European Institute of Oncology
name: Maria Cristina Leonardi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 protocol. BMC Cancer. 2022 Apr 2;22(1):358. doi: 10.1186/s12885-022-09305-w.