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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123929
• Other study ID #: 05/117
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2005
• Last updated: August 3, 2009
• Start date: January 2005
• Est. completion date: May 2009

Study information

• Verified date: August 2009
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel
100 mg/m2 every 3 weeks times 4
• doxorubicin
75 mg/m2 every 3 weeks times 4

Locations

Country	Name	City	State
Spain	Servicio de Oncologia Medica, Hospital Clinico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid	UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin		2005-2009	No
Secondary	response rate to doxorubicin versus docetaxel		2005-2013	No