Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer
Information source: Hospital San Carlos, Madrid
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: docetaxel (Drug); doxorubicin (Drug)
Phase: Phase 2
Status: Recruiting
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
Overall contact:
Miguel Martin, MD, PhD, Phone: +34-913303000, Ext: 3546, Email: mmartin@geicam.org
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Miguel Martin, MD, PhD, Phone: +34-913303000, Ext: 3546, Email: mmartin@geicam.org
Servicio de Oncologia Medica, Hospital Clinico San Carlos, Madrid 28040, Spain; Recruiting
Antonio Casado, MD, Phone: +34-3303000, Ext: 3546
Miguel Martin, MD, PhD, Principal Investigator
José Antonio Vidart, MD, PhD, Sub-Investigator
Additional Information
Starting date: January 2005
Ending date: June 2013
Last updated: May 14, 2008
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