Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
Primary Purpose
Breast Cancer, Radiation Therapy
Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
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
Sites / 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 PauloRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RT
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03213925
First Posted
July 8, 2017
Last Updated
July 8, 2017
Sponsor
Instituto do Cancer do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03213925
Brief Title
Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
Official Title
Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Radiation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Ipsilateral breast tumor recurrence (IBTR)
Description
IBTR is defined from the date from complete response of neoadjuvant chemotherapy to the date of any ipsilateral locoregional recurrence or deth.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gustavo N Marta, PhD
Phone
+55 11 38934538
Email
gustavo.marta@hc.fm.usp.br
Facility Information:
Facility Name
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
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo N Marta, PhD
Phone
+55138934538
Email
gustavo.marta@hc.fm.usp.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
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