Clinical trial · Interventional
Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer
Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression Profile-Based Test to Select Patients for Preoperative Taxane/Anthracycline Chemotherapy for Stage I-III Breast Cancer
- 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)
Primary Objectives: 1. To prospectively evaluate the predictive accuracy of a previously discovered gene expression profile-based test to foretell pathologic complete response (pCR) to preoperative paclitaxel/FAC (5-fluorouracil, doxorubicin, cyclophosphamide) chemotherapy for stage I-III breast cancer. 2. To evaluate if our genomic predictive test is specific to the paclitaxel/FAC regimen or it also predicts increased sensitivity to FAC only chemotherapy. Secondary Objectives: 1. To discover a molecular profile that is associated with pCR after FAC chemotherapy alone 2. To establish a prospectively collected gene expression profile data bank of breast cancer for future studies 3. To compare the pCR rates between patients who receive 6 courses FAC and those who receive sequential paclitaxel /FAC chemotherapies.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paclitaxel + Additional FAC/FEC
- description
- 12 weekly Paclitaxel treatments 80 mg/m\^2 by vein (IVPB) over 1 hour + 4 additional FAC or FEC combination chemotherapy treatments; FAC or FEC treatments given once every 3 weeks. FAC Chemotherapy: 5-Fluorouracil 500 mg/m\^2 intravenous (IV) day 1 \& 4 + Doxorubicin 50 mg/m\^2 IV day 1 over 72 hour continuous infusion or IV bolus + Cyclophosphamide 500 mg/m\^2 IV day 1. FEC Chemotherapy: 5-Fluorouracil 500 mg/m\^2 IV day 1 + Epirubicin 100 mg/m\^2 IV day 1 + Cyclophosphamide 500 mg/m\^2 IV day 1.
- interventionNames
- Drug: 5-Fluorouracil
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Paclitaxel
- Drug: Epirubicin
- type
- ACTIVE_COMPARATOR
- label
- FAC/FEC
- description
- 6 courses FAC or FEC Combination Chemotherapy FAC Chemotherapy: 5-Fluorouracil 500 mg/m\^2 intravenous (IV) day 1 \& 4 + Doxorubicin 50 mg/m\^2 IV day 1 over 72 hour continuous infusion or IV bolus + Cyclophosphamide 500 mg/m\^2 IV day 1. FEC Chemotherapy: 5-Fluorouracil 500 mg/m\^2 IV day 1 + Epirubicin 100 mg/m\^2 IV day 1 + Cyclophosphamide 500 mg/m\^2 IV day 1.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed stage I-III invasive carcinoma of the breast for whom adjuvant chemotherapy is indicated. Patients must have intact or measurable residual cancer (by mammogram, ultra sonogram or physical exam) in the breast. Women of childbearing potential must have a negative pregnancy test (serum or urine beta Human chorionic gonadotropin (HCG)) prior to initiation of chemotherapy. 2. Patients should have adequate organ function to tolerate chemotherapy. 3. Patient must be willing to undergo a one-time pretreatment research FNA biopsy Exclusion Criteria: 1. Patients who have completed lumpectomy, segmental mastectomy or modified radical mastectomy and, therefore no longer have any measurable cancer left in their breast are not eligible. 2. Patients with stage IV, metastatic breast cancers are not eligible. 3. Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, for example Patients who are pregnant or lactating are not eligible.
References
Publications (1)
- DERIVEDDesmedt C, Di Leo A, de Azambuja E, Larsimont D, Haibe-Kains B, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. Multifactorial approach to predicting resistance to anthracyclines. J Clin Oncol. 2011 Apr 20;29(12):1578-86. doi: 10.1200/JCO.2010.31.2231. Epub 2011 Mar 21. PMID 21422418