Clinical trial · Interventional
Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast Cancer
Phase II, Open, Not Randomized Clinical Trial, to Evaluate the Sequential Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in her2 Negative Breast Cancer Patients
NCT00721747CI-TRIAL-00006517unknownPhase 2ClinicalTrials.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 determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel, Liposomal doxorubicine and Cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Unique arm
- description
- 4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv
- interventionNames
- Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide
Primary outcomes (1)
- measure
- Determine proportion of Pathological complete responses
- timeFrame
- At the end of the treatment, after Surgery.
Secondary outcomes (6)
- measure
- Determine proportion of clinical responses
- timeFrame
- At the end of the treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Brest adenocarcinoma stages II/III * Female * Informed consent signed * HER2 negative * Age\>18 years old * ECOG \< 1 * Proper organic function regarding the following criteria: 1. ANC \> 2,0 x 109L, platelets \> 100 x 109L and hemoglobin \> 10g/dL (transfusion is allowed) 2. Hepatic Function: i.Bilirubin \< 1,5 x UNL ii.AST ,ALT \< 2,5 x UNL iii.Alkaline phosphatase \< 5 UNL iv.Patients with AST and /or ALT \> 1.5 x UNL and alkaline phosphatase \> 2.5 x UNL will not be selected for the study c.Renal function: creatinine \< 1,25 x UNL, or creatinine clearance \> 60 mL/min d.Normal Cardiac function, confirmed with FEVI \>50% and electrocardiogram. * Patients should be available for treatment and follow up and must be treated in investigator or co-investigator site * Negative pregnancy test(performed 7 days before treatment) Exclusion Criteria: * Previous treatment for breast cancer (CT, RT, IT, HT) * Stages IIIb, IIIc or IV or invasive bilateral breast cancer * Previous neoplasias treated with Anthracyclines or Taxanes (Paclitaxel or Docetaxel) * Pregnant or breastfeeding females * Neurotoxicity Grade 2 * FEV≤50% or any cardiac disease in which anthracyclines are contraindicated * Other severe diseases regarding investigator criteria * Any neurological or psychiatric pathology * Previous neoplasia different from breast cancer except: 1. skin cancer(no melanoma) 2. In situ cervix Carcinoma 3. Ipsilateral in situ ductal carcinoma 4. In situ lobular in situ carcinoma 5. Any other carcinoma without evidence disease in last 10 years * Treatment chronic with corticoids (except patients starting 6 months before inclusion with low dosages (\* 20 mg methylprednisolone or equivalent) * Concomitant treatment with Hormone ovarian replacement therapy * Contraindication for corticoids * Concomitant treatment with another investigational drugs * Included in another clinical trial with any drug in 30 days before inclusion study * Concomitant treatment with another anticancer therapy * Male patients * Hypersensibility to any study drug or components
References
Publications (0)
Data not yet available
No reference posted for this study.