Clinical trial · Interventional
Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer
Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer
NCT01329627CI-TRIAL-00014606TAME-01terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Toxicity
Summary
Brief summary (as posted)
The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative 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 |
|---|---|---|---|
| Locally Advanced HER2-negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel/doxorubicin/cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel/doxorubicin/cyclophosphamide
- interventionNames
- Drug: Paclitaxel/doxorubicin/cyclophosphamide
Primary outcomes (1)
- measure
- Incidence of febrile neutropenia
- timeFrame
- 18 weeks
- description
- Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%
Secondary outcomes (1)
- measure
- Efficacy
- timeFrame
- From the beginning of treatment until surgery, progression and death
- description
- Efficacy will be assessed by: 1. Tumor measurements using MRI 2. Pathologic complete response 3. Progression-free survival 4. Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced breast cancer diagnosed by guided core biopsy * T \> 2 cm (any N), or any T and node positive (needle biopsy is required) * Non-metastatic disease assessed by computed tomography and bone scintigraphy * Histological grade 2 and Ki67 \> 15% or * Histological grade 3 or * Any triple negative (TN) or * Inflammatory breast cancer (IBC) * Normal left ventricular ejection fraction (LVEF) * HER2-negative disease Exclusion Criteria: * Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast) * Clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders * LVEF value below institutional limits of normal * Predominant lobular carcinoma histology * Grade 1 tumors * Detected or suspicious distant metastasis * Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN * Male sex * HER2-positive breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.