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Breast Cancer

Capecitabine + Lapatinib w/wo IMC-A12 for HER2 Positive Breast Cancer (CTSU N0733)
Randomized Phase II Trial of Capecitabine and Lapatinib With or Without IMC-A12 in Patients With HER2 Positive Breast Cancer Previously Treated With Trastuzumab and an Anthracycline and/or a Taxane
Status Conditions Phase Study ID
Closed Breast Cancer Phase II CTSU N0733

RATIONALE: Drugs used in chemotherapy, such as capecitabine, 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 cell growth. Monoclonal antibodies, such as cixutumumab, 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. It is not yet known whether capecitabine and lapatinib are more effective with or without monoclonal antibody therapy in treating locally advanced or metastatic breast cancer.

PURPOSE: This randomized phase II trial is studying capecitabine and lapatinib to see how well they work compared with capecitabine, lapatinib, and cixutumumab in treating patients with previously treated HER2-positive stage IIIB, stage IIIC, or stage IV breast cancer.

Hannah M. Linden, MD
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed breast cancer, meeting one of the following criteria:

    • Locally advanced disease (i.e., stage IIIB or IIIC [T4 primary tumor] disease)
    • Metastatic disease
  • Disease progressed after treatment with regimens that included trastuzumab (Herceptin®) in combination with an anthracycline and/or a taxane

    • Must have received 1-2 prior chemotherapy regimens in the neoadjuvant, adjuvant, or metastatic setting

      • One regimen must have included treatment with an anthracycline and/or a taxane
    • Prior treatment with trastuzumab required unless there is a contraindication for trastuzumab treatment
  • HER2-positive disease, defined by any of the following:

    • Validated IHC assay score of 3+ (defined as uniform, intense staining of > 30% of invasive tumor cells)
    • Average HER2 gene copy number > 6
    • Gene amplified (HER2:D17Z1 ratio > 2.20)
  • Measurable disease according to RECIST criteria
  • No evidence of active brain metastases, including leptomeningeal involvement

    • CNS metastasis controlled* by prior surgery and/or radiotherapy is allowed NOTE: *To be considered controlled, there must have been no symptoms for at least 2 months or no evidence of progression prior to study entry AND corticosteroid therapy must have been discontinued
  • Hormone receptor status not specified


  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin > 9.0 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (5 times ULN if elevations are due to liver metastases)
  • Serum creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 30 mL/min
  • Fasting glucose < 120 mg/dL

    • Diabetes allowed provided blood glucose level meets the above criterion
  • INR ≤ 1.5 times ULN
  • LVEF ≥ 50% by MUGA or ECHO
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to provide tissue and blood samples for research purposes
  • Able to complete questionnaires by self or with assistance
  • No other stage III or IV invasive cancer within the past 5 years
  • No other malignancy requiring active treatment, except nonmelanoma skin cancer or carcinoma in situ of the cervix

    • History of prior malignancy allowed provided patient is not receiving other specific treatment for their malignancy
  • No current, active hepatic or biliary disease, except Gilbert syndrome's or asymptomatic gallstones
  • No New York Heart Association class III or IV cardiovascular disease
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Poorly controlled diabetes
    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situation that would preclude compliance with study requirements
  • No co-morbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety of the prescribed study regimens
  • Not immunocompromised (other than that related to the use of corticosteroids), including known HIV-positivity with an AIDS-defining illness

    • HIV-positive patients with a CD4 count within normal range and who have no history of an AIDS-defining illness are eligible


  • See Disease Characteristics
  • Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting allowed
  • More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy
  • More than 4 weeks since prior radiotherapy, except a single dose of palliative radiotherapy or radiotherapy to a non-target lesion

    • Prior radiotherapy to a target lesion is allowed only if there has been clear progression of the lesion since completion of radiotherapy
    • Recovered from prior radiotherapy
  • No more than 2 prior chemotherapy regimens for metastatic disease
  • No prior treatment with any therapy targeting IGF-I, IGF-II, or its receptors (either monoclonal antibody or tyrosine kinase inhibitor) including, but not limited to, any of the following:

    • Cixutumumab
    • CP-751871
    • AMG-479
    • INSM-18
    • MK-0646 (h7C10)
    • 19D12
    • R1507
    • OSI-906
    • BMS-536924
    • PPP
    • NVP-AEW541
  • No other prior therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase inhibitor) including, but not limited to, any of the following:

    • Lapatinib ditosylate
    • Gefitinib
    • Erlotinib hydrochloride
    • Cetuximab
    • Panitumumab
  • No concurrent agents that would contraindicate study treatment, including any of the following:

    • CYP3A4 inhibitors and inducers, including grapefruit and grapefruit juice
    • Warfarin, cimetidine, allopurinol, sorivudine or brivudine, ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir
  • No concurrent treatment in another clinical study in which investigational procedures are performed or investigational therapies are administered
  • No other concurrent chemotherapeutic agents, biologic agents, or radiotherapy
Last Updated
December 17, 2012
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.