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Doxorubicin |
Adriamycin; Rubex |
Clinical Trial: Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel Or Doxorubicin in Locally Advanced Breast Cancer
This study is currently recruiting patients.
|
Purpose
After a trucut biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to received 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 received then the opposite drug , hormones, Herceptin and radiation as indicated.
| Condition | Intervention | Phase |
|---|---|---|
| Breast Cancer | Drug: docetaxel, doxorubicin | Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
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
Further Study Details:
Primary Outcomes: correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin
Secondary Outcomes: response rate to doxorubicin vs docetaxel
Expected Total Enrollment: 150
Secondary Outcomes: response rate to doxorubicin vs docetaxel
Expected Total Enrollment: 150
Study start: January 2005
Last follow-up: July 2005
The aim of the study is to define the genetic signature which predicts the response to single drug doxorubicin versus docetaxel. 150 patients will be included. Affimetrix microarrays will be produced and the genetic pattern will be correlated with the response to doxorubicin and docetaxel.
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Locally advanced, inoperable breast carcinoma
- Signed informed consent
Exclusion Criteria:
- Age >75
- Cardiac disease, LEFT <50%
- Hyperbilirubinemia
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00123929
Miguel Martin, MD, PhD +34-913303000 Ext. 3546 mmartin@geicam.org
Spain
Servicio de Oncologia Medica, Hospital Clinico San Carlos, Madrid, 28040, Spain; Recruiting
Antonio Casado, MD +34-3303000 Ext. 3546
Miguel Martin, MD, PhD, Principal Investigator
Miguel Martin, MD, PhD, Principal Investigator
Study chairs or principal investigators
Eduardo Diaz-Rubio, MD, PhD, Study Director, Servicio de Oncologia Medica, Hospital Universitario San Carlos, Madrid, Spain
More Information
Study ID Numbers: 05/117
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 25, 2005
ClinicalTrials.gov Identifier: NCT00123929
Health Authority: Spain: Spanish Agency of Medicines
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 25, 2005
ClinicalTrials.gov Identifier: NCT00123929
Health Authority: Spain: Spanish Agency of Medicines
ClinicalTrials.gov processed this record on 2005-07-26
Resources
- Adriamycin (Drug Digest)
- Doxorubicin (Drug Digest)
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