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Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer (LABC)

This study is currently recruiting participants.
Verified May 2010 by Hospital de Cancer de Barretos - Fundacao Pio XII
Sponsor:
Collaborator:
University of Sao Paulo General Hospital
Information provided by:
Hospital de Cancer de Barretos - Fundacao Pio XII
ClinicalTrials.gov Identifier:
NCT00820690
First received: January 9, 2009
Last updated: June 21, 2011
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Drug: doxorubicin
Drug: cyclophosphamide
Drug: paclitaxel
Procedure: Surgery D30 after chemotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Cancer de Barretos - Fundacao Pio XII:

Primary Outcome Measures:
  • Clinical objective and pathological responses to chemotherapy [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • tumor concordance measurement among physical, radiologic and pathologic exams [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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

  • security of oncoplastic surgery after neoadjuvant chemotherapy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    use and security of oncoplastic surgery after neoadjuvant chemotherapy

  • overall actuarial survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

frozen tissue; parafin tissue


Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
clinical stage III
Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel
 Drug: doxorubicin
4 cycles AC: doxorubicin 60mg/m2
Other Name: clinical and radiologic response
Drug: cyclophosphamide
4 cycles AC: cyclophosphamide 600mg/m2
Other Name: clinical and radiologic response
Drug: paclitaxel
4 cycles T: paclitaxel 175mg/m2 after 4 AC
Other Name: clinical, radiologic and pathologic response
Procedure: Surgery D30 after chemotherapy
Surgery D30 after chemotherapy
Other Names:
  • clinical, radiologic and pathologic response
  • neoadjuvant chemotherapy
  • conservative breast surgery
  • oncoplastic surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820690

Contacts
Contact: René Aloisio C Vieira, MD; PhD 55-17-3321.6600 ext 7009 nucleopesquisador@hcancerbarretos.com.br
Contact: Maria Aparecida A Koike Folgueira, MD; PhD 55-17-3082.6580 makoike@lim24.fm.usp.br

Locations
Brazil
Hospital de Câncer de Barretos - Fundação Pio XII Recruiting
Barretos, São Paulo, Brazil, 14.784-400
Contact: René Aloisio C Vieira, MD, PhD     55-17-3321.6600 ext 7009     nucleopesquisador@hcancerbarretos.com.br    
Contact: Cristiane M Fregnani, Nurse     55-17-3321.6600 ext 7009     nucleopesquisador@hcancerbarretos.com.br    
Principal Investigator: René Aloisio C Vieira, MD, PhD            
Sponsors and Collaborators
Hospital de Cancer de Barretos - Fundacao Pio XII
University of Sao Paulo General Hospital
Investigators
Study Chair: Maria Aparecida A Koike Folgueira, MD, PhD Faculdade de Medicina - Universidade de São Paulo
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: René Aloisio da Costa Vieira, Department of Surgical Oncology
ClinicalTrials.gov Identifier: NCT00820690     History of Changes
Other Study ID Numbers: 135/2008
Study First Received: January 9, 2009
Last Updated: June 21, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital de Cancer de Barretos - Fundacao Pio XII:
neoadjuvant chemotherapy
advanced breast cancer
microarray
correlation analysis
oncoplastic surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013