Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

NCT ID: NCT03213925

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2025-07-01

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.

Conditions

Breast Cancer; Radiation Therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT

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.

Group Type: EXPERIMENTAL

Radiation therapy

Intervention Type: RADIATION

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)

Interventions

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)

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Nader Marta

Radiation Oncologist and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Gustavo N Marta, PhD

Role: CONTACT

gustavo.marta@hc.fm.usp.br

+55 11 38934538

Facility Contacts

Gustavo N Marta, PhD

Role: primary

gustavo.marta@hc.fm.usp.br

+55138934538

Other Identifiers

RT alone

Identifier Type: -

Identifier Source: org_study_id