Clinical trial · Interventional
Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer
A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Operable Breast Cancer
- 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)
Some studies have demonstrated the efficacy of Abraxane in treating breast cancer in both adjuvant and metastatic settings. Few data is available on Abraxane in neoadjuvant treatment for breast cancer. The aim of this project is to evaluate tailored primary systemic therapy with weekly Abraxane (125mg/m2) Combined With Q3week Xeloda (1250mg/m2) in early operable (stage of T2-4N0-3M0) breast cancer. This study will be an open label non randomized, single arm, single center study.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
| Xeloda | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abraxane Combined With Xeloda
- description
- Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
- interventionNames
- Drug: Abraxane
- Drug: Xeloda
Primary outcomes (1)
- measure
- ORR(CR+PR)
- timeFrame
- Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment
- description
- To evaluate the efficacy of concurrent Abraxane and Xeloda as neoadjuvant regimen in terms of: ORR(CR+PR), downstaging rates in tumor size and axillary lymph node. Pathological Complete Response(pCR) defined by: defined as ypT0, ypN0 (the absence of residual invasive and in situ cancer on evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of informed consent 2. Women and men at least 18 years of age or older. 3. Pathological confirmation of breast cancer 4. Tumor stage(TNM):T2-4N0-3M0 5. No evidence of distant metastasis 6. Adequate bone marrow, hepatic, and renal function 7. Measurable disease as per RECIST criteria 8. Karnofsky≥70 9. Laboratory criteria: PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST\<2\*ULN Exclusion Criteria: 1. Presence of metastatic disease. 2. Inflammatory breast cancer. 3. Bilateral breast cancer. 4. previous chemotherapy or hormonal therapy for current breast neoplasm. 5. other malignant tumors (concurrent or previous). 6. Pregnant woman. 7. Hypersensitive to any drug in Abraxane or Xeloda regimen or any ingredient of Abraxane or Xeloda. 8. Any severe systemic disease contraindicating chemotherapy
References
Publications (0)
Data not yet available