Inflammatory Breast CancerConSIBreCNCT06131632
Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy
A study testing Breast conserving surgery and Radical modified mastectomy in people with Inflammatory Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Breast Cancer
- What is being tested?
- Breast conserving surgery and Radical modified mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 1 Jan 2028
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with inflammatory breast cancer
- Clinical complete response after neoadjuvant chemiotherapy
- Targeted tumor
- Written informed consent
Who cannot join
- Metastasis
- Progression disease
- Recurrent disease
- Contraindications to adjuvant radiation therapy
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
Fondazione Policlinico Universitario A. Gemelli IRCCS,
Roma, 00168
GIANLUCA FRANCESCHINI, +390630155701, gianluca.franceschini@policlinicogemelli.it
Lorenzo Scardina
About this study
Official title: Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial
Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast.
Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy.
Read more
In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response.
There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.
- Conditions
- Inflammatory Breast Cancer
- Being tested
- Breast conserving surgery, Radical modified mastectomy
- Keywords
- inflammatory breast cancer, breast conserving surgery, radical mastectomy
- Medical subject headings
- Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast conserving surgeryProcedure or surgery
Remove only a small part of the breast
Radical modified mastectomyProcedure or surgery
Remove all the breast parenchyma, nipple and skin
| Study group | Role | What they receive |
|---|---|---|
| Breast conserving surgery | Experimental | Not described Receives: Procedure: Breast conserving surgery |
| Radical modified mastectomy | Active comparator | Not described Receives: Procedure: Radical modified mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrence rate
Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy
Measured: 24 months
Secondary outcomes (2)
local recurrence-free survival
Rate of disease free survival after breast conserving surgery vs radical mastectomy
Measured: 24 months
overall survival
overall survival after breast conserving surgery vs radical mastectomy
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 posted14 Nov 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131632
- Sponsor's protocol ID
- Consibrec Trial
- Acronym
- ConSIBreC
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06131632
- Acronym / sponsor ID
- ConSIBreC / Consibrec Trial
- Conditions
- Inflammatory Breast Cancer
- Keywords
- inflammatory breast cancer, breast conserving surgery, radical mastectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 Nov 2023 (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.
Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast.
Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy.
In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response.
There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast conserving surgery | Experimental | Procedure: Breast conserving surgery |
| Radical modified mastectomy | Active comparator | Procedure: Radical modified mastectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with inflammatory breast cancer
- Clinical complete response after neoadjuvant chemiotherapy
- Targeted tumor
- Written informed consent
Key exclusion criteria (4 listed)
- Metastasis
- Progression disease
- Recurrent disease
- Contraindications to adjuvant radiation therapy
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 |
|---|---|---|
| Breast conserving surgeryRemove only a small part of the breast | Procedure or surgery | Breast conserving surgery |
| Radical modified mastectomyRemove all the breast parenchyma, nipple and skin | Procedure or surgery | Radical modified mastectomy |
Primary outcome
local recurrence rate
Time frame: 24 months
Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy
2 secondary outcomes
local recurrence-free survival
Time frame: 24 months
overall survival
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 23 Jan 2024.
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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.
Fondazione Policlinico Universitario A. Gemelli IRCCS,
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast conserving surgery and Radical modified mastectomy in people with Inflammatory Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 23 Jan 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrence rate (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 23 Jan 2024.