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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

Phase 2
18 Years
Open (Enrolling)
HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

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


I. To compare progression-free survival of HER2+ breast cancer patients randomized to
receive lapatinib and capecitabine +/- IMC-A12.


I. To assess the safety and tolerability of lapatinib and capecitabine +/- IMC-A12 in HER2+
breast cancer patients.

II. To compare the overall survival time, time to treatment failure, confirmed tumor
response rate, and duration of response of lapatinib and capecitabine +/- IMC-A12 in HER2+
breast cancer patients.

III. To assess patient compliance per treatment arm and to compare overall quality of life
and treatment side effects via patient-reported outcomes between treatment arms.


I. To determine the role of the following in predicting response to lapatinib and
capecitabine +/- IMC-A12:

II. Expression patterns and/or activation IGF- and ErbB family of receptors and signaling
molecules in formalin-fixed, paraffin-embedded breast tumor tissue.

III. Expression patterns and/or activation IGF- and ErbB receptors and signaling molecules
in circulating tumor cells from breast cancer patients.

IV. Changes in expression patterns and/or activation IGF- and ErbB receptors and signaling
molecules following treatment with lapatinib and capecitabine +/- IMC-A12 in circulating
tumor cells from breast cancer patients.

V. Expression patterns of IGF-1, IGF-II, insulin, growth hormone, and the IGF binding
proteins in the serum of breast cancer patients.

VI. Changes in expression patterns of IGF-1, IGF-II, insulin, growth hormone, and the IGF
binding proteins in the serum of breast cancer patients.

VII. As part of ongoing research for NCCTG breast studies, we are banking paraffin-embedded
tissue blocks/slides and blood products (i.e., serum, plasma, and buffy coat) for future

VIII. To assess the proportion of patients whose pathologic specimens were correctly
diagnosed as HER2 positive (according to 2007 ASCO CAP guidelines) metastatic breast cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor
status (estrogen receptor- or progesterone receptor-positive vs other) and number of prior
chemotherapy regimens in the metastatic setting (2 vs 1 vs none). The first 10 patients
enrolled on this study are assigned to cohort 1 (safety analysis). All other patients are
assigned to cohort 2 (randomized treatment).

COHORT 1 (SAFETY ANALYSIS): Patients receive cixutumumab IV over 1-1½ hours on days 1, 8,
and 15. Patients also receive oral capecitabine twice daily on days 1-14 and oral lapatinib
ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.

COHORT 2 (RANDOMIZED TREATMENT): Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib
ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also
receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and on day 8 of courses 1 and 2 for biomarker
laboratory studies. Serum and circulating tumor cell biomarkers are analyzed by
immunohistochemistry or immunofluorescence for changes in protein expression (total and
phosphorylated). Tumor tissue samples obtained at the time of original diagnosis are
analyzed by immunohistochemistry for protein biomarkers.

Patients complete quality of life questionnaires periodically. After completion of study
treatment, patients are followed every 3 months until disease progression and then every 6
months for up to 5 years.

Inclusion Criteria:

- 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 anthracyclineand/or a

- 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, intensestaining 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

- CNSmetastasis controlled* by prior surgery and/or radiotherapy is allowed

- 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 canceror
carcinoma in situ of the cervix

- History of prior malignancy allowed providedpatient is not receiving other
specific treatment for their malignancy

- No current, active hepatic or biliary disease, except Gilbert syndrome's
orasymptomatic gallstones

- No New York Heart Association class III or IV cardiovascular disease

- No concurrent uncontrolled illness including, but not limited to, any of the

- 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

- 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

- No other concurrent chemotherapeutic agents, biologic agents, or radiotherapy

- 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
(eithermonoclonal antibody or tyrosine kinase inhibitor) including, but not limited
to, anyof the following:

- Cixutumumab

- CP-751871

- AMG-479

- INSM-18

- MK-0646 (h7C10)

- 19D12

- R1507

- OSI-906

- BMS-536924


- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate. The distribution of PFS time will be estimated by the Kaplan-Meier (1958) method for each treatment group. Median PFS times will be estimated using Kaplan-Meier estimates with 95% confidence intervals. Supplementary analyses of PFS include a Cox regression with treatment group and the stratification factors as covariates; as well as estimation of the 6-month PFS rate within each treatment group and comparison between the treatment groups using χ² testing.

Outcome Time Frame:

From randomization to the earliest date of documentation of disease progression, up to 5 years

Safety Issue:


Principal Investigator

Paul Haluska

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

Related Keywords:

  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • IGF-1R
  • IMC-A12
  • Breast Neoplasms
  • Breast Neoplasms, Male



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Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee  37662
Guardian Oncology and Center for Wellness Missoula, Montana  59804
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Bay Area Tumor Institute Oakland, California  94609
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
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Toledo Community Hospital Oncology Program CCOP Toledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy Hospital Toledo, Ohio  43623
University of Toledo Toledo, Ohio  43614
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Upper Valley Medical Center Troy, Ohio  45373
Saint Ann's Hospital Westerville, Ohio  43081
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Conklin Regional Cancer Center Aberdeen, South Dakota  57401
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Southwest VA Regional Cancer Center Norton, Virginia  24273
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Saint Francis Hospital Federal Way, Washington  98003
Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Providence - Saint Peter Hospital Olympia, Washington  98506-5166
Good Samaritan Community Hospital Puyallup, Washington  98372
Minor and James Medical PLLC Seattle, Washington  98104
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
Northwest CCOP Tacoma, Washington  98405
Multicare Health System Tacoma, Washington  98415
Saint Clare Hospital Tacoma, Washington  98499
Saint Joseph Medical Center Tacoma, Washington  98405
Edwards Comprehensive Cancer Center Huntington, West Virginia  25701
Saint Vincent Hospital Green Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's Hospital Green Bay, Wisconsin  54303
Saint Mary's Hospital Green Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent Hospital Green Bay, Wisconsin  54301-3526
Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
University of Maryland Greenebaum Cancer Center Baltimore, Maryland  21201
Jupiter Medical Center Jupiter, Florida  33458
Elkhart Clinic Elkhart, Indiana  46515
Memorial Healthcare System - Joe DiMaggio Children's Hospital Hollywood, Florida  33021
Mount Sinai Medical Center CCOP Miami Beach, Florida  33140
Michiana Hematology Oncology PC-Elkhart Elkhart, Indiana  46514
Michiana Hematology Oncology PC-Plymouth Plymouth, Indiana  46563
Michiana Hematology Oncology PC-South Bend South Bend, Indiana  46601
Michiana Hematology Oncology-PC Westville Westville, Indiana  46391
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
Michiana Hematology Oncology PC-Niles Niles, Michigan  49120
Central Care Cancer Center-Carrie J Babb Cancer Center Bolivar, Missouri  65613
Skaggs Cancer Center Branson, Missouri  65616
North Coast Cancer Care-Clyde Clyde, Ohio  43410
Community Health Partners Regional Medical Center Elyria, Ohio  44035
University of Tennessee - Knoxville Knoxville, Tennessee  37920
Skagit Valley Hospital Mt. Vernon, Washington  98273
Evergreen Hematology and Oncology PS Spokane, Washington  99218
Holy Family Memorial Hospital Manitowoc, Wisconsin  54221
Salinas Valley Memorial Salinas, California  93901
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Cancer Care Center at Island Hospital Anacortes, Washington  98221
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Highline Medical Center-Main Campus Burien, Washington  98166
Providence Regional Cancer Partnership Everett, Washington  98201
United General Hospital Sedro-Woolley, Washington  98284
Gundersen Lutheran La Crosse, Wisconsin  54601
Saint Nicholas Hospital Madison, Wisconsin  53715
Kaiser Permanente-Franklin Denver, Colorado  80205
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California  94704
Carle Foundation - Carle Cancer Center Urbana, Illinois  61801
Michiana Hematology Oncology PC-Mishawaka Mishawaka, Indiana  46545-1470
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa  52403
Marie Yeager Cancer Center Saint Joseph, Michigan  49085
Hematology Oncology Associates of Central New York PC East Syracuse, New York  13057
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Sanford Bismarck Medical Center Bismarck, North Dakota  58501
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin  53226
Springfield Regional Medical Center Springfield, Ohio  45505
Toledo Clinic Cancer Centers-Bowling Green Bowling Green, Ohio  43402
Toledo Clinic Cancer Centers-Maumee Maumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio  43623
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370
PeaceHealth Southwest Medical Center Vancouver, Washington  98664
Providence Willamette Falls Medical Center Oregon City, Oregon  97045