Clinical trial · Interventional
Predictors for Response to Dose-dense Docetaxel and Epirubicin Breast Cancer
Molecular Markers Predictive Response to Dose Dense Chemotherapy With Epirubicin and Docetaxel in Sequences for Locally Advanced 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)
Molecular markers predicting response to dose dense chemotherapy with epirubicin and docetaxel in sequence for locally advanced breast cancer Protocol summary. Principal Investigator Hans P. Eikesdal, Professor, Dept. of Oncology, Haukeland University Hospital \& Dept. of Clinical Science, University of Bergen Project leader: Professor Per Eystein Lønning, Dept. of Oncology, Haukeland University Hospital \& Dept. of Clinical Science, University of Bergen Collaborators. Dept of Surgery - Responsible: Turid Aas, Consultant Surgeon Participants. Dept of Oncology Stephanie Geisler, Consultant Oncologist Jurgen Geisler, Consultant Oncologist Type of Study Phase II, Translational research Scientific aims: Addressing factors predicting response to dose intensive epirubicin followed by docetaxel sequential therapy Treatment regimen: epirubicin 60 mg/m2 on a 2 weekly basis x 4 followed by docetaxel 100 mg/m2 2-weekly x 4. Patients: Breast cancer patients below 65 years of age suffering from large (\>4 cm largest diameter, non-inflammatory and / or N2-N3) primary breast cancer. . Clinical aim: Assessing responsiveness to this dose intensive regimen. Number of patients to be enrolled: 60 - 100
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 |
|---|---|---|---|
| Stage III Breast Cancer AJCC V7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epirubicin/docetaxel sequential | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- epirubicin/docetaxel sequential
- description
- Epirubicin/docetaxel sequential, i.e. one arm study with Epirubicin 4 cycles 60 mg/m2 q2w, followed by docetaxel 4 cycles, 100 mg/m2 q2w. Each course with pegfilgrastim.
- interventionNames
- Other: epirubicin/docetaxel sequential
Primary outcomes (1)
- measure
- To correlate molecular parameters to objective response to each of the 2 regimens applied.
- timeFrame
- 10 years
- description
- To correlate molecular parameters to objective response to sequential dose-dense therapy with epirubicin followed by docetaxel in primary locally advanced breast cancer.
Secondary outcomes (2)
- measure
- To correlate molecular parameters to relapse-free and overall survival.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Primary breast cancer \>4cm in diameter and / or lymph node status N2-3. * Age 65 years or younger * "Limited" distant metastases allowed, but patients with massive distant metastases should be excluded * Willing to participate in the study Exclusion Criteria: * Known allergy toward any of the cytotoxic compounds to be administered (epirubicin and doxorubicin) * Liver enzymes \> 2 times upper normal limit or bilirubin \> 3 times upper normal limit * Other medical conditions making them unfit for dose-dense therapy * Cardiac insufficiency; for patients not to receive trastuzumab, decision whether to exclude such patients will be at the physicians discretion. Considering patients with HER-2 positive tumors who should have trastuzumab, exclusion criteria will be according to the NBCG (Norwegian Breast Cancer Group) general guidelines (www.NBCG.net).
References
Publications (2)
- DERIVEDHatletvedt ND, Engebrethsen C, Geisler J, Geisler S, Aas T, Lonning PE, Gansmo LB, Knappskog S. The impact of functional MDM2-polymorphisms on neutrophil counts in breast cancer patients during neoadjuvant chemotherapy. BMC Cancer. 2025 Feb 20;25(1):308. doi: 10.1186/s12885-025-13675-2. PMID 39979836
- DERIVEDVenizelos A, Engebrethsen C, Deng W, Geisler J, Geisler S, Iversen GT, Aas T, Aase HS, Seyedzadeh M, Steinskog ES, Myklebost O, Nakken S, Vodak D, Hovig E, Meza-Zepeda LA, Lonning PE, Knappskog S, Eikesdal HP. Clonal evolution in primary breast cancers under sequential epirubicin and docetaxel monotherapy. Genome Med. 2022 Aug 11;14(1):86. doi: 10.1186/s13073-022-01090-2. PMID 35948919