Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03213925
• Other study ID #: RT alone
• Status: Recruiting
• Phase: Phase 2
• First received: July 8, 2017
• Last updated: July 8, 2017
• Start date: June 1, 2017
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2017
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Gustavo N Marta, PhD
• Phone: +55 11 38934538
• Email: gustavo.marta[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiation Therapy

Intervention

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)

Locations

Country	Name	City	State
Brazil	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

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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