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NCT Number: NCT06131632

Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS,

Roma, 00168, Italy

Location contact

GIANLUCA FRANCESCHINI

CONTACT

[email protected]

+390630155701

GIANLUCA FRANCESCHINI

PRINCIPAL_INVESTIGATOR

Lorenzo Scardina

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breast conserving surgery

Procedure

Remove only a small part of the breast

Radical modified mastectomy

Procedure

Remove all the breast parenchyma, nipple and skin

Primary outcomes

  1. local recurrence rate

    Time frame: 24 months

    Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy

Secondary outcomes

  1. local recurrence-free survival

    Time frame: 24 months

    Rate of disease free survival after breast conserving surgery vs radical mastectomy

  2. overall survival

    Time frame: 24 months

    overall survival after breast conserving surgery vs radical mastectomy

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: ConSIBreC

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Nov 14, 2023
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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