Breast CancerNCT04679454
Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer
A study testing Phase I and Phase II in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Phase I and Phase II
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2021to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IEO, European Institute of Oncology IRCCS
Milan, 20141
Maria Cristina Leonardi, MD
About this study
Official title: Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Phase I, Phase II
- Keywords
- preoperative radiotherapy, radiosurgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase IRadiation
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 IIRadiation
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 group | Role | What they receive |
|---|---|---|
| Preoperative Radiation Treatment | Experimental | Preoperative Radiation treatment with CyberKnife Receives: Radiation: Phase I; Radiation: Phase II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: time frame:8 weeks
Secondary outcomes (7)
Incidence of chronic toxicity
Chronic skin/soft tissue, bone, lung and heart toxicities incidence measured according to NCI CTCAE v. 4.03
Measured: time frame: 6 months - 3 years
Cosmetic outcomes
Measured according to the 4 points scale (poor, fair, good, excellent)
Measured: time frame: 1 - 3 years
Post surgery complications
Reporting of any post surgery complication (rate of infection, seroma, hematoma, necrosis, delayed wound healing)
Measured: time frame: within 30 days of surgery
Disease free survival
establish the rate of disease free survival
Measured: time frame: 1- 3 years
Local relapse
establish the rate of local relapse
Measured: time frame: 1 - 3 years
Overall survival
establish the rate of overall survival
Measured: time frame: 3 years
Breast cancer specific survival
establish the rate of breast cancer specific survival
Measured: time frame: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start31 Jul 2021
- Primary completionMar 2026 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Cristina Leonardi, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679454
- Sponsor's protocol ID
- IEO 1308 - AIRC IG-23118
- Status last verified
- Jun 2024
- First submitted
- 24 Nov 2020
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37650981Zerella 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.
PubMed 35366825
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04679454
- Acronym / sponsor ID
- IEO 1308 - AIRC IG-23118
- Conditions
- Breast Cancer
- Keywords
- preoperative radiotherapy, radiosurgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative Radiation Treatment | Experimental | Radiation: Phase I, Radiation: Phase IIPreoperative Radiation treatment with CyberKnife |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven unifocal adenocarcinoma
- T1-T2
- Tumor size up to 2.5 cm
- cN0
- Age ≥ 18 years old
Key exclusion criteria (7 listed)
- Tumor close to skin or chest wall
- Pure non-invasive tumor
- Prior RT to the chest
- Neoadjuvant chemotherapy
- Collagenopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase ITo 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. | Radiation | Preoperative Radiation Treatment |
| Phase IIThe 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. | Radiation | Preoperative Radiation Treatment |
Primary outcome
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).
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
7 secondary outcomes
Incidence of chronic toxicity
Time frame: time frame: 6 months - 3 years
Cosmetic outcomes
Time frame: time frame: 1 - 3 years
Post surgery complications
Time frame: time frame: within 30 days of surgery
Disease free survival
Time frame: time frame: 1- 3 years
Local relapse
Time frame: time frame: 1 - 3 years
Overall survival
Time frame: time frame: 3 years
Breast cancer specific survival
Time frame: time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Derived from this study: PubMed 37650981Zerella 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.
- Derived from this study: PubMed 35366825Zerella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Cristina Leonardi principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase I and Phase II in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Cristina Leonardi, MD (+39 02 57489037, cristina.leonardi@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Identify the maximum tolerated dose (MTD) (time frame: time frame:2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04679454, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.