Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

NCT ID: NCT06131632

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Breast conserving surgery

Group Type EXPERIMENTAL

Breast conserving surgery

Intervention Type PROCEDURE

Remove only a small part of the breast

Radical modified mastectomy

Group Type ACTIVE_COMPARATOR

Radical modified mastectomy

Intervention Type PROCEDURE

Remove all the breast parenchyma, nipple and skin

Interventions

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Breast conserving surgery

Remove only a small part of the breast

Intervention Type PROCEDURE

Radical modified mastectomy

Remove all the breast parenchyma, nipple and skin

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS,

Roma, , Italy

Site Status

Countries

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Italy

Facility Contacts

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GIANLUCA FRANCESCHINI

Role: primary

+390630155701

Lorenzo Scardina

Role: backup

Other Identifiers

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Consibrec Trial

Identifier Type: -

Identifier Source: org_study_id

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