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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.
Sponsor:
Collaborator:
UNC Lineberger Comprehensive Cancer Center
Information provided by:
Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT00123929
First received: July 22, 2005
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate to doxorubicin versus docetaxel [ Time Frame: 2005-2013 ] [ Designated as safety issue: No ]

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
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Miguel Martin, MD, Hospital San Carlos
ClinicalTrials.gov Identifier: NCT00123929     History of Changes
Other Study ID Numbers: 05/117
Study First Received: July 22, 2005
Last Updated: August 3, 2009
Health Authority: Spain: Spanish Agency of Medicines

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
Doxorubicin
 Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2012