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Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer (LABC)
This study is currently recruiting participants.
Verified by Hospital de Cancer de Barretos - Fundacao Pio XII, January 2009
First Received: January 9, 2009   Last Updated: January 20, 2009   History of Changes
Sponsor: Hospital de Cancer de Barretos - Fundacao Pio XII
Collaborator: University of Sao Paulo General Hospital
Information provided by: Hospital de Cancer de Barretos - Fundacao Pio XII
ClinicalTrials.gov Identifier: NCT00820690
  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: Cohort, 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:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Surgery
Drug Information available for: Cyclophosphamide Doxorubicin Doxorubicin hydrochloride Paclitaxel Myocet
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:
  • overall actuarial survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

frozen tissue; parafin tissue


Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2009 (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
Drug: cyclophosphamide
4 cycles AC: cyclophosphamide 600mg/m2
Drug: paclitaxel
4 cycles T: paclitaxel 175mg/m2 after 4 AC
Procedure: Surgery D30 after chemotherapy
Surgery D30 after chemotherapy

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, São Paulo
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:
Folgueira MA, Carraro DM, Brentani H, Patrão DF, Barbosa EM, Netto MM, Caldeira JR, Katayama ML, Soares FA, Oliveira CT, Reis LF, Kaiano JH, Camargo LP, Vêncio RZ, Snitcovsky IM, Makdissi FB, e Silva PJ, Góes JC, Brentani MM. Gene expression profile associated with response to doxorubicin-based therapy in breast cancer. Clin Cancer Res. 2005 Oct 15;11(20):7434-43.
Andre F, Mazouni C, Hortobagyi GN, Pusztai L. DNA arrays as predictors of efficacy of adjuvant/neoadjuvant chemotherapy in breast cancer patients: current data and issues on study design. Biochim Biophys Acta. 2006 Dec;1766(2):197-204. Epub 2006 Aug 9. Review.
Apple SK, Suthar F. How do we measure a residual tumor size in histopathology (the gold standard) after neoadjuvant chemotherapy? Breast. 2006 Jun;15(3):370-6. Epub 2005 Sep 26.
Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34.
Eltahir A, Heys SD, Hutcheon AW, Sarkar TK, Smith I, Walker LG, Ah-See AK, Eremin O. Treatment of large and locally advanced breast cancers using neoadjuvant chemotherapy. Am J Surg. 1998 Feb;175(2):127-32.
Fernández-Sánchez M, Gamboa-Dominguez A, Uribe N, García-Ulloa AC, Flores-Estrada D, Candelaria M, Arrieta O. Clinical and pathological predictors of the response to neoadjuvant anthracycline chemotherapy in locally advanced breast cancer. Med Oncol. 2006;23(2):171-83.
Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. Epub 2005 May 16.
Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85.
Goldstein NS, Decker D, Severson D, Schell S, Vicini F, Margolis J, Dekhne NS. Molecular classification system identifies invasive breast carcinoma patients who are most likely and those who are least likely to achieve a complete pathologic response after neoadjuvant chemotherapy. Cancer. 2007 Oct 15;110(8):1687-96.
Keam B, Im SA, Kim HJ, Oh DY, Kim JH, Lee SH, Chie EK, Han W, Kim DW, Moon WK, Kim TY, Park IA, Noh DY, Heo DS, Ha SW, Bang YJ. Prognostic impact of clinicopathologic parameters in stage II/III breast cancer treated with neoadjuvant docetaxel and doxorubicin chemotherapy: paradoxical features of the triple negative breast cancer. BMC Cancer. 2007 Nov 1;7:203.
Kuerer HM, Newman LA, Smith TL, Ames FC, Hunt KK, Dhingra K, Theriault RL, Singh G, Binkley SM, Sneige N, Buchholz TA, Ross MI, McNeese MD, Buzdar AU, Hortobagyi GN, Singletary SE. Clinical course of breast cancer patients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol. 1999 Feb;17(2):460-9.
Kurosumi M. Significance and problems in evaluations of pathological responses to neoadjuvant therapy for breast cancer. Breast Cancer. 2006;13(3):254-9. Review.
Molina R, Filella X, Zanon G, Pahisa J, Alicarte J, Munoz M, Farrus B, Ballesta AM. Prospective evaluation of tumor markers (c-erbB-2 oncoprotein, CEA and CA 15.3) in patients with locoregional breast cancer. Anticancer Res. 2003 Mar-Apr;23(2A):1043-50.
Prisack HB, Karreman C, Modlich O, Audretsch W, Danae M, Rezai M, Bojar H. Predictive biological markers for response of invasive breast cancer to anthracycline/cyclophosphamide-based primary (radio-)chemotherapy. Anticancer Res. 2005 Nov-Dec;25(6C):4615-21.
Rouzier R, Mathieu MC, Sideris L, Youmsi E, Rajan R, Garbay JR, André F, Marsiglia H, Spielmann M, Delaloge S. Breast-conserving surgery after neoadjuvant anthracycline-based chemotherapy for large breast tumors. Cancer. 2004 Sep 1;101(5):918-25.
Schott AF, Roubidoux MA, Helvie MA, Hayes DF, Kleer CG, Newman LA, Pierce LJ, Griffith KA, Murray S, Hunt KA, Paramagul C, Baker LH. Clinical and radiologic assessments to predict breast cancer pathologic complete response to neoadjuvant chemotherapy. Breast Cancer Res Treat. 2005 Aug;92(3):231-8.
Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16.
van der Hage JA, van de Velde CJ, Julien JP, Tubiana-Hulin M, Vandervelden C, Duchateau L. Preoperative chemotherapy in primary operable breast cancer: results from the European Organization for Research and Treatment of Cancer trial 10902. J Clin Oncol. 2001 Nov 15;19(22):4224-37.
van der Hage JA, van de Velde CJ, Julien JP, Floiras JL, Delozier T, Vandervelden C, Duchateau L. Improved survival after one course of perioperative chemotherapy in early breast cancer patients. long-term results from the European Organization for Research and Treatment of Cancer (EORTC) Trial 10854. Eur J Cancer. 2001 Nov;37(17):2184-93.
Faneyte IF, Schrama JG, Peterse JL, Remijnse PL, Rodenhuis S, van de Vijver MJ. Breast cancer response to neoadjuvant chemotherapy: predictive markers and relation with outcome. Br J Cancer. 2003 Feb 10;88(3):406-12.

Responsible Party: Department of Surgical Oncology ( René Aloisio da Costa Vieira )
Study ID Numbers: 135/2008
Study First Received: January 9, 2009
Last Updated: January 20, 2009
ClinicalTrials.gov Identifier: NCT00820690     History of Changes
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 30, 2009



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