Clinical trial · Interventional
Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer
Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer
NCT01180335CI-TRIAL-00122328REMAGUS04completedPhase 3ClinicalTrials.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)
This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Genomic driven chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- 4 cycles FEC followed by 4 cycles docetaxel
- interventionNames
- Drug: Chemotherapy
- type
- EXPERIMENTAL
- label
- Genomic driven chemotherapy
- description
- High DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.
- interventionNames
- Drug: Genomic driven chemotherapy
Primary outcomes (1)
- measure
- Complete response rate based on the histology
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Invasive breast cancer not eligible for conservative surgery * Her2 negative * Amount of tumor cells \>30% on HES slides * RIN\>6 and amount of RNA\>1 ug * No metastases * Subject, age \> 18 years and \<65 years old * Signed written informed consent * PS 0-1 * No previous treatment for breast cancer * Adequate organ function * FEVG \>50% Exclusion Criteria: * In situ carcinoma * Multifocal cancers * Her2+ * Presence of metastasis * Genomic testing not feasible because of tumor cells \<30%, RIN\<6, insufficient amount of RNA * Organ dysfunction that contraindicates chemotherapy
References
Publications (1)
- RESULTHamy AS, Derosa L, Valdelievre C, Yonekura S, Opolon P, Priour M, Guerin J, Pierga JY, Asselain B, De Croze D, Pinheiro A, Lae M, Talagrand LS, Laas E, Darrigues L, Grandal B, Marangoni E, Montaudon E, Kroemer G, Zitvogel L, Reyal F. Comedications influence immune infiltration and pathological response to neoadjuvant chemotherapy in breast cancer. Oncoimmunology. 2019 Nov 14;9(1):1677427. doi: 10.1080/2162402X.2019.1677427. eCollection 2020. PMID 32002287