Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Breast Cancer |
| Intervention | Drug: docetaxel Drug: doxorubicin |
| Phase | Phase 2 |
| Sponsor | Hospital San Carlos, Madrid |
| Responsible Party | Hospital San Carlos, Madrid |
| ClinicalTrials.gov Identifier | NCT00123929 |
| First Received | July 22, 2005 |
| Last Updated | August 3, 2009 |
| Last verified | August 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 22, 2005 |
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| Last Updated Date | August 3, 2009 |
| Start Date | January 2005 |
| Estimated Primary Completion Date | May 2009 |
| Current Primary Outcome Measures | correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin [Time Frame: 2005-2009] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | response rate to doxorubicin versus docetaxel [Time Frame: 2005-2013] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer |
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| Official Title | Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer |
| 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. |
| 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 |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Breast Cancer |
| Intervention | Drug: docetaxel 100 mg/m2 every 3 weeks times 4 Other Names: taxotereDrug: doxorubicin 75 mg/m2 every 3 weeks times 4 Other Names: adriamycin |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 250 |
| Estimated Completion Date | May 2009 |
| Estimated Primary Completion Date | May 2009 |
| Eligibility 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Spain |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00123929 |
|---|---|
| Other Study ID Numbers | 05/117 |
| Has Data Monitoring Committee | No |
| Information Provided By | Hospital San Carlos, Madrid |
| Study Sponsor | Hospital San Carlos, Madrid |
| Collaborators | UNC Lineberger Comprehensive Cancer Center |
| Investigators | Study Director: Eduardo Diaz-Rubio, MD, PhD Servicio de Oncologia Medica, Hospital Universitario San Carlos, Madrid, SpainPrincipal Investigator: Martin Miguel, MD, PhD Hospital San Carlos, Madrid, Spain |
| Verification Date | August 2009 |
Locations[ + expand ][ + ]
| Servicio de Oncologia Medica, Hospital Clinico San Carlos | Madrid, Spain, 28040 |
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