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NCT Number: NCT04679454

Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IEO, European Institute of Oncology IRCCS

Milan, 20141, Italy

Location status: Recruiting

Location contact

Maria Cristina Leonardi, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phase I

Radiation

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

Radiation

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 outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. Incidence of chronic toxicity

    Time frame: time frame: 6 months - 3 years

    Chronic skin/soft tissue, bone, lung and heart toxicities incidence measured according to NCI CTCAE v. 4.03

  2. Cosmetic outcomes

    Time frame: time frame: 1 - 3 years

    Measured according to the 4 points scale (poor, fair, good, excellent)

  3. Post surgery complications

    Time frame: time frame: within 30 days of surgery

    Reporting of any post surgery complication (rate of infection, seroma, hematoma, necrosis, delayed wound healing)

  4. Disease free survival

    Time frame: time frame: 1- 3 years

    establish the rate of disease free survival

  5. Local relapse

    Time frame: time frame: 1 - 3 years

    establish the rate of local relapse

  6. Overall survival

    Time frame: time frame: 3 years

    establish the rate of overall survival

  7. Breast cancer specific survival

    Time frame: time frame: 3 years

    establish the rate of breast cancer specific survival

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Morra, MD

CONTACT

[email protected]

+39 02 57489037

Maria Cristina Leonardi, MD

CONTACT

[email protected]

+39 02 57489037

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Dec 22, 2020
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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