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Sponsors and Collaborators: |
Hospital San Carlos, Madrid UNC Lineberger Comprehensive Cancer Center |
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Information provided by: | Hospital San Carlos, Madrid |
ClinicalTrials.gov Identifier: | NCT00123929 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer |
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 |
---|---|
1: Active Comparator
doxorubicin
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Drug: doxorubicin
75 mg/m2 every 3 weeks times 4
|
2
docetaxel
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Drug: docetaxel
100 mg/m2 every 3 weeks times 4
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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).
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Servicio de Oncologia Medica, Hospital Clinico San Carlos | |
Madrid, Spain, 28040 |
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: | Hospital San Carlos ( Miguel Martin, MD ) |
Study ID Numbers: | 05/117 |
Study First Received: | July 22, 2005 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00123929 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
breast cancer neoadjuvant chemotherapy genetic signature doxorubicin docetaxel |
Docetaxel Anti-Bacterial Agents Skin Diseases |
Breast Neoplasms Doxorubicin Breast Diseases |
Docetaxel Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Breast Diseases |