Clinical trial · Interventional
Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in Breast Cancer
A Study to Assess the Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in the Treatment of Operable Breast Cancer
NCT01647672CI-TRIAL-00007556unknownPhase 2 / Phase 3ClinicalTrials.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)
Select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.
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 |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abraxane
- description
- Abraxane for neoadjuvant chemotherapy
- interventionNames
- Drug: Abraxane
Primary outcomes (1)
- measure
- therapeutic assessment
- timeFrame
- 6 months
- description
- therapeutic assessment
Secondary outcomes (1)
- measure
- Adverse reactions and disease-free survival
- timeFrame
- 2 year
- description
- Adverse reactions during the treatment and disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Karnofsky ≥ 70 2. Provision of informed consent 3. Pathological confirmation of breast cancer 4. Tumor stage (TNM):T2-4bN0-3M0 5. Measurable disease as per RECIST criteria 6. Not previously treated with radiotherapy, chemotherapy or biological therapy. 7. Laboratory criteria: * PLT ≥ 100\*109/L * WBC ≥ 4000/mm3 * HGB ≥ 10g/dl * GOT,GPT,ALP ≤ 2\*ULN * TBIL,DBIL,CCr ≤ 1.5\*ULN Exclusion Criteria: 1. Pregnant woman 2. History of organ transplantation 3. With mental disease 4. With severe infection or active gastrointestinal ulcers 5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes 6. Disease-free period of other malignant tumor is less than 5 years (except cured basal cell skin cancer and cervical carcinoma in situ) 7. With heart disease 8. Experimental drug allergy
References
Publications (0)
Data not yet available
No reference posted for this study.