Clinical trial · Interventional
Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The Decision to Terminate Early Due to Difficulties in Recruiting Participants and Conducting the Study.
Summary
Brief summary (as posted)
Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Nanoxel M | Drug | — | UNRESOLVED |
| Taxotere | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nanoxel M
- description
- AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
- interventionNames
- Drug: Nanoxel M
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- Taxotere
- description
- AC(Doxorubicin, Cyclophosphamide) followed by Taxotere
- interventionNames
- Drug: Taxotere
- Drug: Doxorubicin
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who were diagnosed with primary breast cancer by core biopsy 2. Patients who have been identified as HER2 negative in the tissue obtained through core needle biopsy and have confirmed the positive / negative status of ER (Estrogen receptor) and Progesterone receptor (PR) * HER2 positive is defined as IHC 3+ or FISH + 3. Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0) Exclusion criteria: 1. Patients who have distant metastasis 2. Patients who have cystitis or urinary obstruction 3. Patients who have history of thromboembolism or coagulation disorder 4. Patients who have Interstitial lung disease ans liver cirrhosis ( \> Child-Pugh class B) 5. Patients who have Insulin-Dependent Type II diabete mellitus
References
Publications (0)
Data not yet available