Clinical trial · Observational
Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
NCT00820690CI-TRIAL-00018766LABCunknownClinicalTrials.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)
The purpose of this study is to analyze gene expression signature and immunohistochemical markers associated with clinical and pathological response to neoadjuvant chemotherapy in locally advanced breast cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Clinical stage III
- description
- Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection)
- interventionNames
- Drug: doxorubicin
- Drug: cyclophosphamide
- Drug: paclitaxel
- Procedure: Surgery
Primary outcomes (1)
- measure
- Clinical objective and pathological responses to chemotherapy
- timeFrame
- 8 months
- description
- Clinical and radiological examinations to be performed before chemotherapy, after the 4 cycle of AC and before surgery. Pathologic evaluation to be performed 30 days after the last cycle of chemotherapy, i.g. after surgery.
Secondary outcomes (4)
- measure
- Clinical, radiologic and pathologic correlation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women with locally advanced women breast cancer * Histology: ductal ou lobular invasive histology * Agreement to take part in the study and signature of the informed consent * Clinical condition to receive doxorubicin/cyclophosphamide and paclitaxel * ECOG 0 or I Exclusion Criteria: * Not clinical stage III * Inflammatory breast cancer * Previous treatment * Previous diagnosis of cancer (except basal cell or squamous cell skin carcinoma and non-invasive cervical carcinoma) * Pregnancy * Absence of clinical condition to receive chemotherapy
References
Publications (21)
- BACKGROUNDFolgueira MA, Carraro DM, Brentani H, Patrao DF, Barbosa EM, Netto MM, Caldeira JR, Katayama ML, Soares FA, Oliveira CT, Reis LF, Kaiano JH, Camargo LP, Vencio RZ, Snitcovsky IM, Makdissi FB, e Silva PJ, Goes JC, Brentani MM. Gene expression profile associated with response to doxorubicin-based therapy in breast cancer. Clin Cancer Res. 2005 Oct 15;11(20):7434-43. doi: 10.1158/1078-0432.CCR-04-0548. PMID 16243817
- BACKGROUNDAndre F, Mazouni C, Hortobagyi GN, Pusztai L. DNA arrays as predictors of efficacy of adjuvant/neoadjuvant chemotherapy in breast cancer patients: current data and issues on study design. Biochim Biophys Acta. 2006 Dec;1766(2):197-204. doi: 10.1016/j.bbcan.2006.08.002. Epub 2006 Aug 9. PMID 16962247
- BACKGROUNDApple SK, Suthar F. How do we measure a residual tumor size in histopathology (the gold standard) after neoadjuvant chemotherapy? Breast. 2006 Jun;15(3):370-6. doi: 10.1016/j.breast.2005.08.002. Epub 2005 Sep 26. PMID 16185870
- BACKGROUNDCarey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34. doi: 10.1158/1078-0432.CCR-06-1109. PMID 17438091
- BACKGROUNDEltahir A, Heys SD, Hutcheon AW, Sarkar TK, Smith I, Walker LG, Ah-See AK, Eremin O. Treatment of large and locally advanced breast cancers using neoadjuvant chemotherapy. Am J Surg. 1998 Feb;175(2):127-32. doi: 10.1016/s0002-9610(97)00279-1. PMID 9515529
- BACKGROUNDFernandez-Sanchez M, Gamboa-Dominguez A, Uribe N, Garcia-Ulloa AC, Flores-Estrada D, Candelaria M, Arrieta O. Clinical and pathological predictors of the response to neoadjuvant anthracycline chemotherapy in locally advanced breast cancer. Med Oncol. 2006;23(2):171-83. doi: 10.1385/MO:23:2:171. PMID 16720917