Status:
COMPLETED
Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Male Breast Carcinoma
Stage IIA Breast Cancer AJCC v6 and v7
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed...
Detailed Description
PRIMARY OBJECTIVE: I. To determine if the pathologic complete response (pCR) in the breast to neoadjuvant weekly paclitaxel with trastuzumab plus lapatinib (THL) is 20% greater than the pCR to weekly...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Pathologic confirmation of invasive breast cancer; patients with inflammatory breast cancer are not eligible
- Clinical stage II-III operable invasive breast cancer with intent to perform surgical resection after neoadjuvant therapy
- Patients with multicentric or bilateral disease are eligible as long as the target lesion meets the eligibility criteria for this study
- Staging to rule out metastatic disease is recommended for clinical stage III patients
- Tumors must be HER2 positive defined as HER2 3+ by immunohistochemical (IHC) assays or gene amplification by fluorescence in situ hybridization (FISH) with a ratio of \>= 2 on invasive tumor
- Estrogen receptor (ER) and progesterone receptor (PgR) status must be known
- The target lesion in the breast must be \>= 1 cm on physical examination or by radiographic measurement; palpable axillary adenopathy will be documented but not serve as measurable disease for the primary endpoint; patients with axillary disease only are not eligible to participate
- Patient agrees to provide pretreatment biopsies
- No prior chemotherapy, hormone therapy, biologic, or radiation therapy with therapeutic intent for this cancer
- Cardiac ejection fraction must be \>= 50% by echocardiogram or multiple gated acquisition (MUGA) scan
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
- Patients must not be pregnant or nursing
- Absolute neutrophil count (ANC) \>= 1,000/ul
- Platelet count \>= 100,000/ul
- Bilirubin =\< 1.5 times upper limit of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 times upper limit of normal (ULN)
- Serum beta-human chorionic gonadotropin (HCG) negative (in female patients unless status-post (s/p) hysterectomy or menopausal or no menses for 24 consecutive months); assay must have a sensitivity of at least 50 mIU/mL
Exclusion
Key Trial Info
Start Date :
February 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00770809
Start Date
February 24 2009
End Date
February 15 2024
Last Update
August 15 2025
Active Locations (318)
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1
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
2
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
3
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
4
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546