Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer

Not Recruiting

Trial ID: NCT00404066


This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC) followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates.

Official Title

Phase II Neoadjuvant Chemotherapy Trial in Clinical Stage II/III Her2Neu Positive Breast Cancer With Sequential AC -> Docetaxel With Concurrent Dual EGFR Kinase Blockade by GW572016 (Lapatinib) Followed by 1 Year Adjuvant Trastuzumab

Stanford Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine



   - Female

   - Histologically-confirmed Her2neu positive breast cancer, by either
   Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+

   - Stage II/III breast cancer including any large primary tumor (> 2 cm), tumors of any
   size associated with skin or chest wall involvement, tumors of any size with axillary
   lymph node involvement, (T2-T4, N0-N2) and those with ipsilateral subclavicular or
   supraclavicular lymph nodes).

   - At least one bi-dimensional, measurable indicator lesion.

   - Between 18 and 70 years of age

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 / Karnofsky ≥ 60% at
   screening and on the first day of treatment.

   - Informed consent must be obtained prior to registration.

   - Cardiac ejection fraction within the institutional range of normal as measured by
   multigated acquisition (MUGA) or echocardiography (ECHO) scan.

   - Absolute neutrophil count > 1,500/mm³

   - Hemoglobin > 8.0 g/dL

   - Platelet count > 100,000/mm³

   - Creatinine within normal institutional limits

   - Total Bilirubin equal to or less than institutional upper limit of normal (ULN)

   - Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline
   phosphatase must be within the range allowing for eligibility. In determining
   eligibility the more abnormal of the two values (AST or ALT) should be used.

   - Eligibility of patients receiving medications or substances known to affect, or with
   the potential to affect the activity or pharmacokinetics of GW572016 will be
   determined following review of their use by the Principal Investigator

      - Antacid use is prohibited 1 hour before and 1 hour after GW572016 dosing.

      - All herbal (alternative) medicines are prohibited.

      - Medications prohibited during the administration of lapatinib .

   - Women of child-bearing potential must have negative pregnancy test and must agree to
   use adequate contraception (hormonal or barrier method of birth control or abstinence)
   prior to study entry and for the duration of study participation.

   - Peripheral neuropathy: must be < grade 1

   - Able to swallow and retain oral medication


   - Evidence of disease outside the breast or chest wall, except for ipsilateral axillary
   , supraclavicular, or infraclavicular lymph nodes.

   - Prior chemotherapy, immunotherapy, or hormonal therapy for breast cancer.

   - More than 3 months between histologic diagnosis and registration on this study.

   - History of other malignancy within the last 5years, except curatively treated basal
   cell carcinoma of the skin or carcinoma in situ of the cervix.

   - Psychological, familial, sociological or geographical conditions which do not permit
   weekly medical follow-up and compliance with the study protocol. Those who are
   medically-unstable, including but not limited to active infection, acute hepatitis,
   deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding,
   uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena
   cava syndrome, and those whose circumstances do not permit completion of the study or
   the required follow-up.

   - Congestive heart failure, abnormal left ventricular ejection fraction (LVEF), angina
   pectoris, uncontrolled cardiac arrhythmias, or other significant heart disease, or who
   have had a myocardial infarction within the past year.

   - Pregnant or lactating

   - Of childbearing potential and not employing adequate contraception

   - History of allergic reactions attributed to compounds of similar chemical or biologic
   composition to GW572016.

   - HIV-positive and receiving combination anti-retroviral therapy are excluded from the
   study because of possible pharmacokinetic interactions with lapatinib. Appropriate
   studies will be undertaken in patients receiving combination anti-retroviral therapy
   when indicated.

   - GI tract disease resulting in an inability to take oral medication, malabsorption
   syndrome, a requirement for IV alimentation, prior surgical procedures affecting
   absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).

   - History of severe hypersensitivity reaction to taxotere or other drugs formulated with
   polysorbate 80.

   - Current active hepatic or biliary disease (with exception of patients with Gilberts
   syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator
   assessment ).


drug: pegfilgrastim

drug: Lapatinib

drug: Doxorubicin

drug: Cyclophosphamide

drug: Docetaxel

drug: filgrastim

drug: dexamethasone

drug: trastuzumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mary Chen

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