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Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00123929
Recruitment Status : Completed
First Posted : July 26, 2005
Last Update Posted : August 6, 2009
Sponsor:
Collaborator:
UNC Lineberger Comprehensive Cancer Center
Information provided by:
Hospital San Carlos, Madrid

Brief Summary:
After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain pathological response. They then receive the opposite drug, hormones, Herceptin, and radiation as indicated.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Drug: doxorubicin Phase 2

Detailed Description:
The aim of the study is to define the genetic signature which predicts the response to single drug doxorubicin versus docetaxel. 250 patients will be included. cDNA microarrays will be produced and the genetic pattern will be correlated with the response to doxorubicin and docetaxel. Secondary aim is the prediction of response by means of IHC determinations (her2, ER, PgR, Ki67, protein TAU), FISH (topoisomerase II alpha, her2) and PCR (topoisomerase II alpha).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
Study Start Date : January 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
doxorubicin
Drug: doxorubicin
75 mg/m2 every 3 weeks times 4
Other Name: adriamycin
2
docetaxel
Drug: docetaxel
100 mg/m2 every 3 weeks times 4
Other Name: taxotere



Primary Outcome Measures :
  1. correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin [ Time Frame: 2005-2009 ]

Secondary Outcome Measures :
  1. response rate to doxorubicin versus docetaxel [ Time Frame: 2005-2013 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced, inoperable breast carcinoma or stage II not amenable to breast preserving surgery (amendment introduced on november 2006)
  • Signed informed consent

Exclusion Criteria:

  • Age >75
  • Cardiac disease; LEFT <50%
  • Hyperbilirubinemia

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 ClinicalTrials.gov identifier (NCT number): NCT00123929


Locations
Spain
Servicio de Oncologia Medica, Hospital Clinico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Hospital San Carlos, Madrid
UNC Lineberger Comprehensive Cancer Center
Investigators
Study Director: Eduardo Diaz-Rubio, MD, PhD Servicio de Oncologia Medica, Hospital Universitario San Carlos, Madrid, Spain
Principal Investigator: Martin Miguel, MD, PhD Hospital San Carlos, Madrid, Spain

Responsible Party: Miguel Martin, MD, Hospital San Carlos
ClinicalTrials.gov Identifier: NCT00123929     History of Changes
Other Study ID Numbers: 05/117
First Posted: July 26, 2005    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by Hospital San Carlos, Madrid:
breast cancer
neoadjuvant chemotherapy
genetic signature
doxorubicin
docetaxel

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Liposomal doxorubicin
Doxorubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors