Clinical trial · Interventional
Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, 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)
RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II/III trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage II or stage III 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathological complete response rate
Secondary outcomes (2)
- measure
- Safety
- measure
- Overall clinical response rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer * Stage II-IIIB disease (T1-4, N1-2, M0) * Previously untreated disease * Previously unresected disease * High-risk disease that is not resectable by lumpectomy alone * Any HER2/neu status (positive, negative, or unknown) allowed * Hormone receptor status: * Any estrogen/progesterone status (positive, negative, or unknown) allowed PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * ECOG performance status 0-2 * Life expectancy \> 3 months * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin \> 9.0 g/dL * Creatinine \< 1.5 mg/dL * Bilirubin \< 1.5 times upper limit of normal (ULN) * ALT and AST \< 2.5 times ULN (5 times ULN if due to Gilbert's disease) * Alkaline phosphatase \< 2.5 times ULN (5 times ULN if due to Gilbert's disease) PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available