Clinical trial · Interventional
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
NCT01432223CI-TRIAL-00017612completedPhase 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 evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.
Conditions
Conditions (3)
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 |
| Effects of Chemotherapy | — | UNRESOLVED | — |
| HER-2 Positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nab-paclitaxel
- description
- Nab-paclitaxel q3w 260mg/m2
- interventionNames
- Drug: Nab-paclitaxel
Primary outcomes (1)
- measure
- To evaluate the pathological complete response rate
- timeFrame
- 1 year from last patient enrolled
Secondary outcomes (5)
- measure
- Disease free survival
- timeFrame
- 5 years from the last patient enrolled
- measure
- Overall response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive breast cancer * T1c-3 N0-2a * Confirmed of hormonal receptor status * HER2 positive confirmed by IHC 3+ or FISH+ * LVEF \> 50% by echocardiogram or MUGA * Adequate EKG * No prior treatment for breast cancer * PS 0-1 * Required baseline laboratory data WBC \> 4,000/mm3 and Neut \> 2,000/mm3 PLT \> 100,000/mm3 Hb \> 9.0g/dl AST and ALT \< ULNx2.5 T-Bil \< 1.5mg/dl Serum creatinin \< 1.5mg/dl * Written informed consent Exclusion Criteria: * With history of hypersensitivity reaction for important drug in this study * With history of invasive breast cancer * Bilateral invasive breast cancer * Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus * Positive for HBs antigen and with history of HVB * With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension * With severe edema * With severe peripheral neuropathy * With severe psychiatric disorder * Pregnant or nursing women * Cases who physician judged improper to entry this trial
References
Publications (1)
- RESULTTanaka S, Iwamoto M, Kimura K, Matsunami N, Morishima H, Yoshidome K, Nomura T, Morimoto T, Yamamoto D, Tsubota Y, Kobayashi T, Uchiyama K. Phase II Study of Neoadjuvant Anthracycline-Based Regimens Combined With Nanoparticle Albumin-Bound Paclitaxel and Trastuzumab for Human Epidermal Growth Factor Receptor 2-Positive Operable Breast Cancer. Clin Breast Cancer. 2015 Jun;15(3):191-6. doi: 10.1016/j.clbc.2014.12.003. Epub 2014 Dec 24. PMID 25579459