Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer
Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jan 2005
Typical duration for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 22, 2005
CompletedFirst Posted
Study publicly available on registry
July 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedAugust 6, 2009
August 1, 2009
4.3 years
July 22, 2005
August 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin
2005-2009
Secondary Outcomes (1)
response rate to doxorubicin versus docetaxel
2005-2013
Study Arms (2)
1
ACTIVE COMPARATORdoxorubicin
2
OTHERdocetaxel
Interventions
Eligibility Criteria
You may qualify if:
- Locally advanced, inoperable breast carcinoma or stage II not amenable to breast preserving surgery (amendment introduced on november 2006)
- Signed informed consent
You may not qualify if:
- Age \>75
- Cardiac disease; LEFT \<50%
- Hyperbilirubinemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servicio de Oncologia Medica, Hospital Clinico San Carlos
Madrid, 28040, Spain
Related Publications (1)
Ruiz-Pinto S, Martin M, Pita G, Caronia D, de la Torre-Montero JC, Moreno LT, Moreno F, Garcia-Saenz JA, Benitez J, Gonzalez-Neira A. Pharmacogenetic variants and response to neoadjuvant single-agent doxorubicin or docetaxel: a study in locally advanced breast cancer patients participating in the NCT00123929 phase 2 randomized trial. Pharmacogenet Genomics. 2018 Nov;28(11):245-250. doi: 10.1097/FPC.0000000000000354.
PMID: 30334909DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eduardo Diaz-Rubio, MD, PhD
Servicio de Oncologia Medica, Hospital Universitario San Carlos, Madrid, Spain
- PRINCIPAL INVESTIGATOR
Martin Miguel, MD, PhD
Hospital San Carlos, Madrid, Spain
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 22, 2005
First Posted
July 26, 2005
Study Start
January 1, 2005
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
August 6, 2009
Record last verified: 2009-08