An interventional study of Phase I and Phase II in Breast Cancer, sponsored by European Institute of Oncology. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by European Institute of Oncology · Not applicable, Interventional, and Treatment
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 79 is close to the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →European Institute of Oncology is the lead sponsor of 184 studies on the registry; 117 are open to participants now.
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Exclusion Criteria:
Preoperative Radiation treatment with CyberKnife
Radiation: Phase I · Radiation: Phase II
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.
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.
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: time frame:2 weeks
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: time frame:8 weeks
Incidence of chronic toxicity
Chronic skin/soft tissue, bone, lung and heart toxicities incidence measured according to NCI CTCAE v. 4.03
Time frame: time frame: 6 months - 3 years
Cosmetic outcomes
Measured according to the 4 points scale (poor, fair, good, excellent)
Time frame: time frame: 1 - 3 years
Post surgery complications
Reporting of any post surgery complication (rate of infection, seroma, hematoma, necrosis, delayed wound healing)
Time frame: time frame: within 30 days of surgery
Disease free survival
establish the rate of disease free survival
Time frame: time frame: 1- 3 years
Local relapse
establish the rate of local relapse
Time frame: time frame: 1 - 3 years
Overall survival
establish the rate of overall survival
Time frame: time frame: 3 years
Breast cancer specific survival
establish the rate of breast cancer specific survival
Time frame: time frame: 3 years
Plan to share: No
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