Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment for Early Stage Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04679454
• Other study ID #: AIRC IG-23118
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 31, 2021
• Est. completion date: March 2029

Study information

• Verified date: August 2021
• Source: European Institute of Oncology
• Contact: Maria Cristina Leonardi, MD
• Phone: +39 02 57489037
• Email: cristina.leonardi[@]ieo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: March 2029
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	IEO, European Institute of Oncology IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Identify the maximum tolerated dose (MTD)	Dose escalation is designed as a 3+3 rule-based study. Acute skin/soft tissue toxicity, measured according to NCI CTCAE v. 4.03. Any Grade 3-4 toxicity related to radioablation is considered dose limiting (DLT).	time frame:2 weeks
Primary	Phase II: Evaluate efficacy measured in terms of pCR rate	Rate of pCR after radioablative treatment, according to Modified Residual Cancer Burden (RCB) index	time frame:8 weeks
Secondary	Incidence of chronic toxicity	Chronic skin/soft tissue, bone, lung and heart toxicities incidence measured according to NCI CTCAE v. 4.03	time frame: 6 months - 3 years
Secondary	Cosmetic outcomes	Measured according to the 4 points scale (poor, fair, good, excellent)	time frame: 1 - 3 years
Secondary	Post surgery complications	Reporting of any post surgery complication (rate of infection, seroma, hematoma, necrosis, delayed wound healing)	time frame: within 30 days of surgery
Secondary	Disease free survival	establish the rate of disease free survival	time frame: 1- 3 years
Secondary	Local relapse	establish the rate of local relapse	time frame: 1 - 3 years
Secondary	Overall survival	establish the rate of overall survival	time frame: 3 years
Secondary	Breast cancer specific survival	establish the rate of breast cancer specific survival	time frame: 3 years