Clinical trial · Interventional
Phase II NCT (Neoadjuvant Chemotherapy) w/ Weekly Abraxane in Combination With Carboplatin & Bevacizumab in Breast Cancer
Phase II Trial of Neoadjuvant Chemotherapy [NCT] With Weekly Nanoparticle Albumin-bound Paclitaxel [Nab-paclitaxel; Abraxane®] in Combination With Carboplatin and Bevacizumab in Women With Clinical Stages I-III 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 paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel albumin-stabilized nanoparticle formulation and carboplatin together with bevacizumab 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| bevacizumab | Drug | Bevacizumab | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant, Surgery, Adjuvant
- description
- Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
- interventionNames
- Drug: bevacizumab
- Drug: carboplatin
- Drug: nab-paclitaxel
- Procedure: Surgery
- Drug: Adjuvant chemotherapy
Primary outcomes (2)
- measure
- Number of Patients With Pathologic Complete Response (pCR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion: * Histologically confirmed breast cancer * Clinically or radiographically measurable residual tumor after core biopsy * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Age ≥18 yrs * Absolute neutrophil count ≥ 1,500/mm³ * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 100,000/ mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Urine protein:creatinine ratio \< 1.0 * AST (aspartate aminotransferase) and ALT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin normal * Women of childbearing potential must use effective contraception * Left ventricular ejection fraction (LVEF) normal by echocardiogram or MUGA Exclusion: * No residual tumor after initial biopsy * Peripheral neuropathy of grade 2 or higher * HER-2 neu overexpression either by IHC 3+ or FISH+ * No history of any prior treatment of breast cancer. * No history of unstable angina or myocardial infarction within the past 12 months * Pregnant or nursing women * Anticoagulation therapy within the last 6 months * History of gastrointestinal bleeding * Recent hemoptysis * No known hepatitis B or HIV seropositivity * No inadequately controlled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg and/or diastolic BP \> 100 mm Hg despite antihypertensive medications * History of hypertensive crisis or hypertensive encephalopathy * New York Heart Association class II-IV congestive heart failure * History of stroke or transient ischemic attack at any time * Significant vascular disease (e.g., aortic aneurysm or aortic dissection) * No symptomatic peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Significant traumatic injury within the past 28 days * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * Serious, non-healing wound, ulcer, or bone fracture * Known hypersensitivity to any component of bevacizumab
References
Publications (1)
- RESULTMrozek E, Layman R, Ramaswamy B, Lustberg M, Vecchione A, Knopp MV, Shapiro CL. Phase II trial of neoadjuvant weekly nanoparticle albumin-bound paclitaxel, carboplatin, and biweekly bevacizumab therapy in women with clinical stage II or III HER2-negative breast cancer. Clin Breast Cancer. 2014 Aug;14(4):228-34. doi: 10.1016/j.clbc.2014.02.005. Epub 2014 Feb 20. PMID 24703985