NCT03213925

Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

After neoadjuvant chemotherapy, patients normally receive either conservative breast surgery or mastectomy followed by radiation therapy. Some patients achieve a complete response after neoadjuvant chemotherapy. Considering that radiation therapy is an effective treatment for subclinical microscopic disease, the question arises whether breast surgery before radiation therapy can be avoided in the subgroup of patients with complete response after neoadjuvant chemotherapy.

Conditions

• Breast Cancer
• Radiation Therapy

Interventions

Type	Name	Description
RADIATION	Radiation therapy	Radiation therapy to the breast with or without regional nodal area is performed within 12 weeks after completion of chemotherapy with conventional dose (25x200cGy). Additional boost of 16 Gy in the primary involved tumor region. Techniques: 3D conformal radiation therapy or intensity modulated radiation therapy (IMRT). Standard systemic treatment for patients with hormonal positive receptor (hormone therapy for at least 5 years) and HER2 positive (trastuzumab for 1 year)

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-07-01
• Completion: 2025-07-01
• First posted: 2017-07-11
• Last updated: 2017-07-11

Locations

1 site across 1 country: Brazil