Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

NCT03213925 | Unknown Phase 2

• 1 other identifier: RT alone
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Ipsilateral breast tumor recurrence (IBTR)

  IBTR is defined from the date from complete response of neoadjuvant chemotherapy to the date of any ipsilateral locoregional recurrence or deth.

  5 years

Study Arms (1)

RT

EXPERIMENTAL

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.

Radiation: Radiation therapy

Interventions

Radiation therapy 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)

RT

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (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, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Gustavo N Marta, PhD

CONTACT

+55 11 38934538; gustavo.marta@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist and Principal Investigator

Study Record Dates

• First Submitted: July 8, 2017
• First Posted: July 11, 2017
• Study Start: June 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2025
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)