Clinical trial · Interventional
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
NCT00123929CI-TRIAL-00002522completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- doxorubicin
- interventionNames
- Drug: doxorubicin
- type
- OTHER
- label
- 2
- description
- docetaxel
- interventionNames
- Drug: docetaxel
Primary outcomes (1)
- measure
- correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin
- timeFrame
- 2005-2009
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRuiz-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 30334909