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Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy (ConSIBreC)

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Not yet enrolling

Conditions

Inflammatory Breast Cancer

Treatments

Procedure: Radical modified mastectomy
Procedure: Breast conserving surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06131632
Consibrec Trial

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Breast conserving surgery
Experimental group
Treatment:
Procedure: Breast conserving surgery
Radical modified mastectomy
Active Comparator group
Treatment:
Procedure: Radical modified mastectomy

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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