Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this 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.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with inflammatory breast cancer

Clinical complete response after neoadjuvant chemiotherapy

Targeted tumor

Written informed consent

Disqualifiers

Metastasis

Progression disease

Recurrent disease

Contraindications to adjuvant radiation therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Breast conserving surgery

    Procedure/Surgery

    Remove only a small part of the breast

  • Radical modified mastectomy

    Procedure/Surgery

    Remove all the breast parenchyma, nipple and skin

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Breast conserving surgeryExperimental treatment 1 intervention
Group B: Radical modified mastectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

local recurrence rate

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

Time frame
24 months

Secondary outcomes

1

local recurrence-free survival

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

Time frame
24 months
2

overall survival

overall survival after breast conserving surgery vs radical mastectomy

Time frame
24 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: