Back to results

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

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Arm Type

Experimental

Arm Description

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

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

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

gustavo.marta@hc.fm.usp.br

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

We'll reach out to this number within 24 hrs