Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

Phase 2

Recruiting

• Conditions: Breast Cancer; Radiation Therapy
• Interventions: Radiation: Radiation therapy

• Registration Number: NCT03213925
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-08
• Last Update Submitted: 2017-07-08
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2020-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Age 40 years or older
• Pathologically confirmed unicentric invasive breast cancer
• Clinical stage T1-3 / N0 or N2 / M0
• Clinical conditions to receive neoadjuvant chemotherapy

Exclusion Criteria

• Prior diagnosis of cancer (exception: in situ cervical tumor and non-melanoma skin)
• Patient is known to be pregnant
• Prior history of radiation therapy in the thoracic region
• Impossibility to perform magnetic resonance imaging

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RT	Radiation therapy	After clinical response, breast magnetic resonance imaging (MRI) is performed and analyzed by two independent radiologists. Complete image response is defined by no enhanced tumor visible on any serial images. 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.

Primary Outcome Measures

Name	Time	Method
Ipsilateral breast tumor recurrence (IBTR)	5 years	IBTR is defined from the date from complete response of neoadjuvant chemotherapy to the date of any ipsilateral locoregional recurrence or deth.

Trial Locations

Locations (1)

Department of Radiology and Oncology of University of São Paulo - Radiation Oncology Unit, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, Brazil