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

Information source: Hospital San Carlos, Madrid
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: docetaxel (Drug); doxorubicin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hospital San Carlos, Madrid

Official(s) and/or principal investigator(s):
Eduardo Diaz-Rubio, MD, PhD, Study Director, Affiliation: Servicio de Oncologia Medica, Hospital Universitario San Carlos, Madrid, Spain
Martin Miguel, MD, PhD, Principal Investigator, Affiliation: Hospital San Carlos, Madrid, Spain

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.

Clinical Details

Official title: Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin

Secondary outcome: response rate to doxorubicin versus docetaxel

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

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

Locations and Contacts

Servicio de Oncologia Medica, Hospital Clinico San Carlos, Madrid 28040, Spain
Additional Information

Starting date: January 2005
Last updated: August 3, 2009

Page last updated: August 23, 2015

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