Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer (LABC)

August 3, 2015 updated by: Barretos Cancer Hospital

Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

The purpose of this study is to analyze gene expression signature and immunohistochemical markers associated with clinical and pathological response to neoadjuvant chemotherapy in locally advanced breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Locally advanced breast cancer is a common condition in development countries. Neoadjuvant chemotherapy gives the opportunity to identify genetic signatures associated with objective clinical and pathological complete responses.

Patients will receive doxorubicin/cyclophosphamide with paclitaxel. Tumor samples collected before and after chemotherapy will be analyzed.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

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

Study Locations

  • Brazil
    • São Paulo
      • Barretos, São Paulo, Brazil, 14.784-400
        • Barretos Cancer Hospital

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women breast cancer, clinical stage III; condition to chemotherapy with doxorubicin/cyclophosphamide and paclitaxel

Description

Inclusion Criteria:

  • Women with locally advanced women breast cancer
  • Histology: ductal ou lobular invasive histology
  • Agreement to take part in the study and signature of the informed consent
  • Clinical condition to receive doxorubicin/cyclophosphamide and paclitaxel
  • ECOG 0 or I

Exclusion Criteria:

  • Not clinical stage III
  • Inflammatory breast cancer
  • Previous treatment
  • Previous diagnosis of cancer (except basal cell or squamous cell skin carcinoma and non-invasive cervical carcinoma)
  • Pregnancy
  • Absence of clinical condition to receive chemotherapy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clinical stage III
Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection)
Drug: doxorubicin
4 cycles AC: doxorubicin 60mg/m2
Other Names:
  • clinical and radiologic response
Drug: cyclophosphamide
4 cycles AC: cyclophosphamide 600mg/m2
Other Names:
  • clinical and radiologic response
Drug: paclitaxel
4 cycles T: paclitaxel 175mg/m2 after 4 AC
Other Names:
  • clinical, radiologic and pathologic response
Procedure: Surgery

The surgery will be performed 30 days after the chemotherapy. The correlation between clinical, radiologic and pathologic response will be reported.

The oncoplastic surgery rate will be reported

Other Names:
  • Mastectomy
  • Oncoplastic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical objective and pathological responses to chemotherapy
Time Frame: 8 months

Clinical and radiological examinations to be performed before chemotherapy, after the 4 cycle of AC and before surgery.

Pathologic evaluation to be performed 30 days after the last cycle of chemotherapy, i.g. after surgery.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical, radiologic and pathologic correlation
Time Frame: 3 years
tumor concordance measurement among pre-operative physical examination (PE), mammography (MG), ultrasound (US), breast MRI and post-operative pathologic measurement concordance with PE, MG, US and MRI
3 years
Surgery
Time Frame: 5 years
The use and security of oncoplastic surgery after neoadjuvant chemotherapy
5 years
Overall actuarial survival
Time Frame: 5 years
5 years
Pathologic complete response
Time Frame: 9 months
Pathologic complete response after neoadjuvant chemotherapy
9 months

Collaborators and Investigators

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

Sponsor

Barretos Cancer Hospital

Collaborators

University of Sao Paulo

Investigators

  • Study Chair: Maria Aparecida A Koike Folgueira, MD, PhD, Faculdade de Medicina - Universidade de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135/2008

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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