Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Phase I: Identify the maximum tolerated dose (MTD) — 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).
• Phase II: Evaluate efficacy measured in terms of pCR rate — time frame:8 weeks
  Rate of pCR after radioablative treatment, according to Modified Residual Cancer Burden (RCB) index

Trial sites (1)

More European Institute of Oncology trials in Italy

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