Clinical trial · Observational
Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer
NCT01732939CI-TRIAL-00013787unknownClinicalTrials.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 study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- AT
- description
- Docetaxel 75 mg/m2, day 1 or paclitaxel 175mg/m2 day 1 plus Epirubicin 75 mg/m2, day 1 or doxorubicine 50mg/m2 day 1 for 6-8 cycles
- label
- AT-NP
- description
- docetaxel 75mg/m2,day 1 or paclitaxel 175mg/m2,day 1 plus doxorubicine 50mg/m2,day 1 or epirubicin 75mg/m2, day 1,for3-4 cycles then switch to vinorelbine 25mg/m2, day 1 and day 8 plus cisplatinum 75mg/m2, day 1 for 3-4 cycles
Primary outcomes (1)
- measure
- pathological complete response rate
- timeFrame
- one year
Secondary outcomes (1)
- measure
- clinical response rate, safety
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of invasive ductal or lobular breast cancer.
* Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.
* no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive)
* Performance Status ECOG \<2
* Age \> 18 years
* Tumor \> 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky \>50%
* Lab test :
* Absolute neutrophil count \> 1,500/mm3
* Total Bilirubin ≤ 2×ULN
* AST and ALT ≤ 2.5×ULN
* serum creatinine ≤ 1.5×ULN
Exclusion Criteria:
* Pregnant or breast feeding patients are excluded
* stage Ⅳ breast cancer
* History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin
* uncontrolled cardiac disease
* Active infection or chronic infection requiring chronic suppressive antibiotics
* History of hypersensitivity reaction to investigating drugsReferences
Publications (0)
Data not yet available
No reference posted for this study.