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Completed

NCT Number: NCT00123929

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Servicio de Oncologia Medica, Hospital Clinico San Carlos

Madrid, 28040, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

100 mg/m2 every 3 weeks times 4

Other names: taxotere

Doxorubicin

Drug

75 mg/m2 every 3 weeks times 4

Other names: adriamycin

Primary outcomes

  1. correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin

    Time frame: 2005-2009

Secondary outcomes

  1. response rate to doxorubicin versus docetaxel

    Time frame: 2005-2013

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Collaborators

  • UNC Lineberger Comprehensive Cancer Center

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jul 26, 2005
Registry last updated
Aug 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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