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Randomized Phase III Trial of Paclitaxel +Trastuzumab + Lapatinib Versus Paclitaxel + Trastuzumab as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer

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Trial Conditions
  • Breast Cancer
  • HER2-positive Breast Cancer
  • HER2/Neu Positive
  • Male Breast Carcinoma
  • Male Breast Cancer
  • Stage II Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
What is the purpose of this trial?

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 by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.

Date & Status

Active, not recruiting

Who can Participate?


18 and older



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

- 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

Gender: Both
Steward Physician(s)
  • Lisa Carey
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
  • Trastuzumab
  • Lapatinib Ditosylate
  • Paclitaxel
  • Laboratory Biomarker Analysis
For more information about this trial, contact

Dorcas Chi

Phone: 617-789-3000

Physician Researcher

Investigator Name:

  • Lisa Carey

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00770809
Volunteers:  Not Accepting Healthy Volunteers

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