Breast CancerPaRTy-BNCT07881341
Anatomy Impact on RT Breast Cancer
An observational study of Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
Prospective observational study. The purpose of this project is to identify a parameter system that will allow to identify a priori the most appropriate radiotherapy technique for each patient undergoing breast radiotherapy at our center. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2023to Dec 2026
- Phase
- Observational
- 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
Study population: Consecutive patients treated for breast cancer (on the left breast) at Radiotherapy Facility of IRCCS IRST in Meldola (FC, Italy).
Who may be able to join
- Female
- Target volume: left breast
- Tumor type: any diagnosis of breast cancer
- Dose prescription: 40.05 Gray/15 fractions
- Patients aged ≥ 18 years old
- Patients willing and able to give informed consent to participate
Who cannot join
- Other concomitant tumor lesions
- Sovraclavear lymph node involvement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oriana Nanni contact
Bernadette Vertogen contact
Italy1 site, 1 recruiting
- Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS
Meldola, FC, 47014
Elisabetta Parisi, MD
Maria Luisa Belli, MP
About this study
Official title: Analysis of Anatomical Parameters in the Radiotherapy of Breast Cancer
Prospective observational study. The purpose of this project is to identify a parameter system that will allow to identify a priori the most appropriate radiotherapy technique for each patient undergoing breast radiotherapy at our center.
All patients will be treated and monitored according to the local clinical practice. A total of at least 30 patients will be included in the study. Dose prescription will be 40.05 Gy (Gray) in 15 fractions.
For each patient, 3 RT treatment plans will be simulated: Three-Dimensional Conformal Radiation Therapy (3D-CRT), Step-and-shoot intensity-modulated radiotherapy (IMRT S\&S), and hybrid technique (3D-CRT+IMRT). A total of 90 plans will be available. The best treatment technique will be chosen based on scoring provided by at least 3 expert clinicians. The primal plan choice will be the one with higher total rate, evaluated as a sum of 3 single rates.
Read the detailed description
To date, at IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST) there is no system of objective criteria that allows the planner to determine the optimal planning and treatment technique based on the patient's characteristics.
This is a prospective observational study (non interventional study). Therefore no changes will be performed on clinical practice already in use.
Any decision about drug administration is made by the physician based on his clinical judgment in the context of clinical practice, independently from the decision to include the patient in this study.
Patients participating in the trial will not be subjected to any procedure that falls outside the clinical practice; in the same way, clinical variables that will be collected for the study are those that are commonly collected by physician in daily clinical practice. A total of at least 30 patients will be included in the study. Dose prescription will be 40.05 Gy (Gray) in 15 fractions. For each patient, 3 RT treatment plans will be simulated: 3D-CRT, IMRT (S\&S), and hybrid technique (3D-CRT+IMRT). A total of 90 plans will be available. The best treatment technique will be chosen based on scoring provided by at least 3 expert clinicians. The primal plan choice will be the one with higher total rate, evaluated as a sum of 3 single rates. The study duration will be approximately 30 months.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for breast cancer at IRST IRCCS Radiotherapy Facility | Consecutive patients treated for breast cancer (on the left breast) at Radiotherapy Facility of IRCCS IRST in Meldola (FC, Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a parameter system for most appropriate radiotherapy technique choice
The purpose of this project is to identify a parameter system that will allow to identify a priori the most appropriate radiotherapy technique for each patient undergoing breast radiotherapy at our center.
Measured: 24 months
Secondary outcomes (1)
Evaluation of the clinician concordance
Assess the concordance within clinician scoring of best treatment choice for each case
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start16 Jun 2023
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881341
- Sponsor's protocol ID
- IRST174.27
- Acronym
- PaRTy-B
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Anatomical Parameters in the Radiotherapy of Breast Cancer
- ClinicalTrials.gov ID
- NCT07881341
- Acronym / sponsor ID
- PaRTy-B / IRST174.27
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Oct 2026 (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.
Prospective observational study. The purpose of this project is to identify a parameter system that will allow to identify a priori the most appropriate radiotherapy technique for each patient undergoing breast radiotherapy at our center.
All patients will be treated and monitored according to the local clinical practice. A total of at least 30 patients will be included in the study. Dose prescription will be 40.05 Gy (Gray) in 15 fractions.
For each patient, 3 RT treatment plans will be simulated: Three-Dimensional Conformal Radiation Therapy (3D-CRT), Step-and-shoot intensity-modulated radiotherapy (IMRT S\&S), and hybrid technique (3D-CRT+IMRT). A total of 90 plans will be available. The best treatment technique will be chosen based on scoring provided by at least 3 expert clinicians. The primal plan choice will be the one with higher total rate, evaluated as a sum of 3 single rates.
Detailed description
To date, at IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST) there is no system of objective criteria that allows the planner to determine the optimal planning and treatment technique based on the patient's characteristics.
This is a prospective observational study (non interventional study). Therefore no changes will be performed on clinical practice already in use.
Any decision about drug administration is made by the physician based on his clinical judgment in the context of clinical practice, independently from the decision to include the patient in this study.
Patients participating in the trial will not be subjected to any procedure that falls outside the clinical practice; in the same way, clinical variables that will be collected for the study are those that are commonly collected by physician in daily clinical practice. A total of at least 30 patients will be included in the study. Dose prescription will be 40.05 Gy (Gray) in 15 fractions. For each patient, 3 RT treatment plans will be simulated: 3D-CRT, IMRT (S\&S), and hybrid technique (3D-CRT+IMRT). A total of 90 plans will be available. The best treatment technique will be chosen based on scoring provided by at least 3 expert clinicians. The primal plan choice will be the one with higher total rate, evaluated as a sum of 3 single rates. The study duration will be approximately 30 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for breast cancer at IRST IRCCS Radiotherapy Facility | – | –Consecutive patients treated for breast cancer (on the left breast) at Radiotherapy Facility of IRCCS IRST in Meldola (FC, Italy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients treated for breast cancer (on the left breast) at Radiotherapy Facility of IRCCS IRST in Meldola (FC, Italy).
Key inclusion criteria (6 listed)
- Female
- Target volume: left breast
- Tumor type: any diagnosis of breast cancer
- Dose prescription: 40.05 Gray/15 fractions
- Patients aged ≥ 18 years old
Key exclusion criteria (2 listed)
- Other concomitant tumor lesions
- Sovraclavear lymph node involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of a parameter system for most appropriate radiotherapy technique choice
Time frame: 24 months
The purpose of this project is to identify a parameter system that will allow to identify a priori the most appropriate radiotherapy technique for each patient undergoing breast radiotherapy at our center.
1 secondary outcome
Evaluation of the clinician concordance
Time frame: 24 months
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 19 Oct 2026.
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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.
Oriana Nanni contact
Bernadette Vertogen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS 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 6 inclusion and 2 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 19 Oct 2026. 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 Oriana Nanni (oriana.nanni@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a parameter system for most appropriate radiotherapy technique choice (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.