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Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer (LABC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00820690
Recruitment Status : Unknown
Verified August 2015 by Barretos Cancer Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2009
Last Update Posted : August 5, 2015
University of Sao Paulo
Information provided by (Responsible Party):
Barretos Cancer Hospital

Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Drug: doxorubicin Drug: cyclophosphamide Drug: paclitaxel Procedure: 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.

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Study Type : Observational
Actual Enrollment : 80 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. Surgery [ Time Frame: 5 years ]
    The use and security of oncoplastic surgery after neoadjuvant chemotherapy

  3. Overall actuarial survival [ Time Frame: 5 years ]
  4. Pathologic complete response [ Time Frame: 9 months ]
    Pathologic complete response after neoadjuvant chemotherapy

Biospecimen Retention:   Samples With DNA
frozen tissue; parafin tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00820690

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Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14.784-400
Sponsors and Collaborators
Barretos Cancer Hospital
University of Sao Paulo
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Study Chair: Maria Aparecida A Koike Folgueira, MD, PhD Faculdade de Medicina - Universidade de São Paulo

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Barretos Cancer Hospital Identifier: NCT00820690    
Other Study ID Numbers: 135/2008
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Keywords provided by Barretos Cancer Hospital:
neoadjuvant chemotherapy
advanced breast cancer
correlation analysis
oncoplastic surgery
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors