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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 26, 2005
Last Update Posted: August 6, 2009
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.
UNC Lineberger Comprehensive Cancer Center
Information provided by:
Hospital San Carlos, Madrid
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 Intervention Phase
Breast Cancer Drug: docetaxel Drug: doxorubicin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hospital San Carlos, Madrid:

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

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

Estimated Enrollment: 250
Study Start Date: January 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: doxorubicin
75 mg/m2 every 3 weeks times 4
Other Name: adriamycin
Drug: docetaxel
100 mg/m2 every 3 weeks times 4
Other Name: taxotere

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).

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

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
  Contacts and Locations
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

Servicio de Oncologia Medica, Hospital Clinico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Hospital San Carlos, Madrid
UNC Lineberger Comprehensive Cancer Center
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
  More Information

Responsible Party: Miguel Martin, MD, Hospital San Carlos
ClinicalTrials.gov Identifier: NCT00123929     History of Changes
Other Study ID Numbers: 05/117
First Submitted: July 22, 2005
First Posted: July 26, 2005
Last Update Posted: August 6, 2009
Last Verified: August 2009

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

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