Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer (LABC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT00820690
First received: January 9, 2009
Last updated: March 30, 2014
Last verified: March 2014
  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

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:


Further study details as provided by Barretos Cancer Hospital:

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

    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.



Secondary Outcome Measures:
  • Clinical, radiologic and pathologic correlation [ 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

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

  • Overall actuarial survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Pathologic complete response [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Pathologic complete response after neoadjuvant chemotherapy


Biospecimen Retention:   Samples With DNA

frozen tissue; parafin tissue


Enrollment: 80
Study Start Date: July 2008
Estimated Study Completion Date: September 2017
Primary Completion Date: April 2012 (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 followed by surgery (mastectomy and axillary lymph node dissection)
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

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:
  • Oncoplastic surgery
  • Mastectomy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14.784-400
Sponsors and Collaborators
Barretos Cancer Hospital
University of Sao Paulo
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: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT00820690     History of Changes
Other Study ID Numbers: 135/2008
Study First Received: January 9, 2009
Last Updated: March 30, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Barretos Cancer Hospital:
neoadjuvant chemotherapy
advanced breast cancer
microarray
correlation analysis
oncoplastic surgery

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

ClinicalTrials.gov processed this record on October 20, 2014