Non-surgical treatment for breast cancer after chemotherapy
Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
This study tests if using radiotherapy alone is a safe and effective option for breast cancer patients who have responded well to chemotherapy, instead of undergoing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Candiolo, Turin and 1 other locations) |
| Trial ID | NCT06281210 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with infiltrating breast carcinoma, specifically triple negative or HER2-positive, who have undergone at least 12 weeks of neoadjuvant chemotherapy.
Not a fit: Patients with bilateral or multicentric tumors, or those with a history of previous breast cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for breast cancer patients, potentially improving their quality of life.
How similar studies have performed: While this approach is innovative, similar studies exploring non-surgical options for breast cancer have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Candiolo, Turin and 1 other locations
- Istituto di Candiolo IRCCS — Candiolo, Turin, Italy (Not_yet_recruiting)
- European Institute of Oncology — Milan, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.