ConSIBreC: Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06131632

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Breast Cancer	Procedure: Breast conserving surgery Procedure: Radical modified mastectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breast conserving surgery	Procedure: Breast conserving surgery Remove only a small part of the breast
Active Comparator: Radical modified mastectomy	Procedure: Radical modified mastectomy Remove all the breast parenchyma, nipple and skin

Arm

Intervention/Treatment

Experimental: Breast conserving surgery

Procedure: Breast conserving surgery

Remove only a small part of the breast

Active Comparator: Radical modified mastectomy

Procedure: Radical modified mastectomy

Remove all the breast parenchyma, nipple and skin

Outcome Measures

Primary Outcome Measures

local recurrence rate [24 months]
Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy

Secondary Outcome Measures

local recurrence-free survival [24 months]
Rate of disease free survival after breast conserving surgery vs radical mastectomy
overall survival [24 months]
overall survival after breast conserving surgery vs radical mastectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with inflammatory breast cancer
Clinical complete response after neoadjuvant chemiotherapy
Targeted tumor
Written informed consent

Exclusion Criteria:

Metastasis
Progression disease
Recurrent disease
Contraindications to adjuvant radiation therapy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT06131632

Other Study ID Numbers:

Consibrec Trial

First Posted:

Nov 14, 2023

Last Update Posted:

Nov 15, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS

inflammatory breast cancer

breast conserving surgery

radical mastectomy

Additional relevant MeSH terms:

Breast Neoplasms

Inflammatory Breast Neoplasms

Study Results

No Results Posted as of Nov 15, 2023