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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
  • Male Breast Cancer
  • Stage II 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 is studying paclitaxel to see how well it works when given together with trastuzumab and/or lapatinib 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 or by stopping them from dividing. 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 together 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?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Pathologically confirmed invasive breast cancer by core needle or incisional biopsy

- Clinical stage II or III disease

- Resectable disease

- HER2- positive tumor, defined as 3+ over expression by immunohistochemistry (IHC) or
gene amplification by fluorescence in situ hybridization (FISH) with a ratio of >= 2
on invasive tumor

- Measurable disease, defined as target lesion in the breast >= 1 cm by physical
examination or radiographic measurement

- No axillary disease only

- Multicentric or bilateral disease allowed provided the target lesion meets
eligibility criteria

- Planning to undergo surgical resection after neoadjuvant therapy

- No inflammatory breast cancer

- No metastatic disease

- Concurrent enrollment in CALGB-150702 required

- Hormone receptor status known

- Menopausal status not specified

- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

- Absolute neutrophil count (ANC) >= 1,000/mm^3

- Platelet count >= 100,000/mm^3

- Bilirubin =< 1.5 times upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective non-hormonal contraception during and for >= 2
months after completion of study treatment

- Cardiac ejection fraction >= 50% by echocardiogram or multiple gated acquisition
(MUGA) scan

- Willing to undergo pretreatment biopsies and submit archival tissue obtained at the
time of surgery

- No concurrent pegfilgrastim

- No prior chemotherapy, hormonal therapy, biologic therapy, or radiotherapy for the
treatment of breast cancer

- No other concurrent chemotherapy or hormonal therapy, except for the following:

- Steroids for adrenal failure

- Hormones for non-disease-related conditions (e.g., insulin for diabetes)

- Intermittent use of dexamethasone as an antiemetic

Gender: Both
Steward Physician(s)
  • Lisa Carey
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Biological
  • trastuzumab
Drug
  • lapatinib ditosylate
  • paclitaxel
Other
  • 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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