Clinical trial · Interventional
Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer
A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel + Anthracycline x 4 Cycles Followed by Docetaxel Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed ≥ 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®- Based Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to slow recruitment of patients
Summary
Brief summary (as posted)
Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer Secondary: * Clinical response rate * To investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer * Type of surgery (radical/conservative)
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 |
|---|---|---|---|
| Ductal Carcinoma | Breast Ductal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
Secondary outcomes (1)
- measure
- Secondary: 1. Clinical response rate 2. to investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer 3. Type of surgery (radical/conservative)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified breast cancer * Large (≥ 3 cm) breast cancer * IIb-IIIa stage * ECOG (Eastern Cooperative Oncology Group) status: 0-1-2 * Adequate bone marrow reserve: (Haemoglobin ≥ 12g/l, Absolute Neutrophil Count (ANC) ≥ 2.0x 10\^9, Platelets ≥100 000) * Laboratory results: * Bilirubin ≤ Upper Limit Normal (ULN) * Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 2.5 ULN, Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 ULN, * Alk.phosph. ≤ 5.0 ULN, * Creatinin ≤ ULN, if borderline calculated at ≤ 60ml/min * Normal cardiac function (the result of Left Ventricular Ejection Function (LVEF) must be above the lower limit of normal for the institution) * Negative pregnancy test * Hormonal receptor status assessed Exclusion Criteria: * Pregnancy or lactation * SGOT and/or SGPT \> 1.5 upper limit normal, associated with Alk.phosph \> 2.5 ULN * Serious medical condition including but not limited to: * Uncontrolled hypertension * Active ulcus pepticum * Non-stable diabetes mellitus * Other contraindication of steroid treatment * Myocardial infarction within the last 6 months prior study entry * Significant neurologic/psychiatric disorders * Active infection * Peripheral neuropathy grade ≥ 2 * Unstable angina * Severe arrhythmia * Participation in other clinical trial * Prior surgery, chemotherapy, hormonotherapy for breast cancer * Past or current history of neoplasm other than breast cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, other cancer curatively treated and with no evidence of disease for at least 7 years * History of hypersensitivity to the investigational products or to drugs with similar chemical structures * Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * Treatment with any investigational product in the last 1 month before study entry. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available