Non-surgical treatment for breast cancer after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of using radiotherapy alone for patients with breast cancer who have achieved a complete pathological response after neoadjuvant chemotherapy. It involves histological confirmation of this response through vacuum-assisted biopsy or excision guided by ultrasound. The primary goal is to demonstrate that this non-surgical approach is not inferior to traditional surgical methods. By focusing on patients with specific types of breast cancer, the study aims to explore innovative treatment options that could potentially reduce the need for surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age\> 18 years
* infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0
* single lesion
* neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice
* conservative surgery proposal
* M0
* tumour bed identified by breast markers placed in pre NACT by radiologist

Exclusion Criteria:

* Bilateral or multicentric tumour
* Presence of microcalcifications visualised on mammography
* Presence of associated DCIS
* Positive history of previous breast cancer
* Positive history of medical or psychiatric conditions preventing adherence to the protocol
* High risk patient

Where it's running

• European Institute of Oncology
  Milan, Italy Recruiting
• Istituto di Candiolo IRCCS
  Candiolo, Turin, Italy Not yet recruiting

Study contacts

• Principal investigator: Elisabetta Rossi, MD — European Institute of Oncology
• Study coordinator: Elisabetta Rossi, MD
• Email: ElisabettaMariaCristina.Rossi@ieo.it
• Phone: +39-0294372191

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.