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Clinical Trials/NCT04679454
NCT04679454RecruitingNot Applicable

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

European Institute of Oncology2 sites in 1 country79 target enrollmentStarted: July 31, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
79
Locations
2
Primary Endpoint
Phase II: Evaluate efficacy measured in terms of pCR rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically proven unifocal adenocarcinoma
  • Tumor size up to 2.5 cm
  • 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

Outcomes

Primary Outcomes

Phase II: Evaluate efficacy measured in terms of pCR rate

Time Frame: time frame:8 weeks

Rate of pCR after radioablative treatment, according to Modified Residual Cancer Burden (RCB) index

Phase I: Identify the maximum tolerated dose (MTD)

Time Frame: time frame:2 weeks

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).

Secondary Outcomes

  • Cosmetic outcomes(time frame: 1 - 3 years)
  • Local relapse(time frame: 1 - 3 years)
  • Incidence of chronic toxicity(time frame: 6 months - 3 years)
  • Disease free survival(time frame: 1- 3 years)
  • Post surgery complications(time frame: within 30 days of surgery)
  • Overall survival(time frame: 3 years)
  • Breast cancer specific survival(time frame: 3 years)

Investigators

Sponsor
European Institute of Oncology
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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