Clinical trial · Interventional
Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
Pilot Neoadjuvant Trial in Breast Cancer With Combination of ABI-007 (Abraxane) and GW572016 (Lapatinib)
- 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 Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving Abraxane together with lapatinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving Abraxane together with lapatinib works in treating patients with stage I, 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lapatinib ditosylate | Drug | Lapatinib | ALIAS |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- 30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: lapatinib ditosylate
- Drug: paclitaxel albumin-stabilized nanoparticle formulation
Primary outcomes (1)
- measure
- Clinical Response Rate (cRR)
- timeFrame
- At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)
- description
- cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)\>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease-neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study. Progressive Disease \<=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Clinical stage I-III disease
* Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm with spiral CT scan
* HER2/neu 3+ by immunohistochemistry or positive by fluorescent in situ hybridization
* No known brain metastases
* Hormone receptor status unspecified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Male or female
* Life expectancy \> 12 weeks
* ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500 mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* LVEF ≥ 50% as measured by echocardiogram or MUGA scan
* No other malignancy within the past year
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to swallow and retain oral medication
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
* No ongoing or active infection
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No gastrointestinal (GI) tract disease that would preclude ability to take oral medication
* No malabsorption syndrome
* No requirement for IV alimentation
* No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy, immunotherapy, radiotherapy, or hormonal therapy for breast cancer
* No prior treatment with epidermal growth factor receptor targeting therapies
* No prior surgical procedures affecting absorption
* No prior surgery for breast cancer
* At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
* Dexamethasone or dexamethasone equivalent dose ≥ 1.5 mg/day, including any of the following:
* Cortisone (≥ 50 mg/day)
* Hydrocortisone (≥ 40 mg/day)
* Prednisone (≥ 10 mg/day)
* Methylprednisolone (≥ 8 mg/day)
* Phenytoin
* Carbamazepine
* Phenobarbital
* Efavirenz
* Nevirapine
* Rifampin
* Rifabutin
* Rifapentine
* Hypericum perforatum (St. John's wort)
* Modafinil
* At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
* Clarithromycin
* Erythromycin
* Troleandomycin
* Delavirdine
* Ritonavir
* Indinavir
* Saquinavir
* Nelfinavir
* Amprenavir
* Lopinavir
* Itraconazole
* Ketoconazole
* Voriconazole
* Fluconazole (doses up to 150 mg/day are permitted)
* Nefazodone
* Fluvoxamine
* Verapamil
* Diltiazem
* Cimetidine
* Aprepitant
* Grapefruit or its juice
* At least 6 months since prior and no concurrent amiodarone
* At least 2 days since prior and no concurrent gastric pH modifiers\*, including any of the following:
* Cimetidine
* Ranitidine
* Nizatidine
* Famotidine
* Omeprazole
* Esomeprazole
* Rabeprazole
* Pantoprazole
* Lansoprazole
* NOTE: \*Antacids are allowed within 1 hour before and after administration of study drug
* No other concurrent investigational agents
* No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or antitumor hormonal therapy
* No concurrent herbal (alternative) medicines
* No concurrent combination antiretroviral therapy for HIV-positive patients
* Concurrent bisphosphonates allowedReferences
Publications (1)
- RESULTKaklamani VG, Siziopikou K, Scholtens D, Lacouture M, Gordon J, Uthe R, Meservey C, Hansen N, Khan SA, Jeruss JS, Bethke K, Cianfrocca M, Rosen S, Von Roenn J, Wayne J, Parimi V, Jovanovic B, Gradishar W. Pilot neoadjuvant trial in HER2 positive breast cancer with combination of nab-paclitaxel and lapatinib. Breast Cancer Res Treat. 2012 Apr;132(3):833-42. doi: 10.1007/s10549-011-1411-8. Epub 2011 Feb 27. PMID 21359953