Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

NCT04679454 | Recruiting

• 1 other identifier: IEO 1308 - AIRC IG-23118
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

preoperative radiotherapy; radiosurgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Incidence of chronic toxicity

  time frame: 6 months - 3 years

• Cosmetic outcomes

  time frame: 1 - 3 years

• Post surgery complications

  time frame: within 30 days of surgery

• Disease free survival

  time frame: 1- 3 years

• Local relapse

  time frame: 1 - 3 years

Study Arms (1)

Preoperative Radiation Treatment

EXPERIMENTAL

Preoperative Radiation treatment with CyberKnife

Radiation: Phase I; Radiation: Phase II

Interventions

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.

Preoperative Radiation Treatment

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.

Preoperative Radiation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

IEO, European Institute of Oncology IRCCS

Milan, 20141, Italy

RECRUITING

Related Publications (2)

• Zerella MA, Zaffaroni M, Ronci G, Dicuonzo S, Rojas DP, Morra A, Gerardi MA, Fodor C, Rondi E, Vigorito S, Penco S, Sargenti M, Baratella P, Vicini E, Morigi C, Kahler-Ribeiro-Fontana S, Galimberti VE, Gandini S, De Camilli E, Renne G, Cattani F, Veronesi P, Orecchia R, Jereczek-Fossa BA, Leonardi MC. A narrative review for radiation oncologists to implement preoperative partial breast irradiation. Radiol Med. 2023 Dec;128(12):1553-1570. doi: 10.1007/s11547-023-01706-6. Epub 2023 Aug 31.

  PMID: 37650981 DERIVED

• Zerella MA, Zaffaroni M, Ronci G, Dicuonzo S, Rojas DP, Morra A, Fodor C, Rondi E, Vigorito S, Botta F, Cremonesi M, Garibaldi C, Penco S, Galimberti VE, Intra M, Gandini S, Barberis M, Renne G, Cattani F, Veronesi P, Orecchia R, Jereczek-Fossa BA, Leonardi MC. Single fraction ablative preoperative radiation treatment for early-stage breast cancer: the CRYSTAL study - a phase I/II clinical trial protocol. BMC Cancer. 2022 Apr 2;22(1):358. doi: 10.1186/s12885-022-09305-w.

  PMID: 35366825 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Maria Cristina Leonardi

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cristina Leonardi, MD

CONTACT

+39 02 57489037; cristina.leonardi@ieo.it

Anna Morra, MD

CONTACT

+39 02 57489037; anna.morra@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 22, 2020
• Study Start: July 31, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)