Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

July 8, 2017 updated by: Gustavo Nader Marta, Instituto do Cancer do Estado de São Paulo
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • 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
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral breast tumor recurrence (IBTR)
Time Frame: 5 years
IBTR is defined from the date from complete response of neoadjuvant chemotherapy to the date of any ipsilateral locoregional recurrence or deth.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

July 8, 2017

First Submitted That Met QC Criteria

July 8, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 8, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT alone

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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