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Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00759642
Recruitment Status : Terminated (IRB decision)
First Posted : September 25, 2008
Results First Posted : May 23, 2017
Last Update Posted : July 1, 2019
Information provided by (Responsible Party):
University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE September 24, 2008
First Posted Date  ICMJE September 25, 2008
Results First Submitted Date  ICMJE April 17, 2017
Results First Posted Date  ICMJE May 23, 2017
Last Update Posted Date July 1, 2019
Study Start Date  ICMJE March 2009
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
Progression Free Survival [ Time Frame: 12 months ]
Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
Progression Free Survival [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
Official Title  ICMJE Phase II Trial of Lapatinib in Women With Hormone Receptor Positive (Estrogen Receptor [ER] and/or Progesterone Receptor [PR] +) Human Epidermal Growth Factor Receptor 2 (HER-2) Negative Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
Brief Summary Hormone receptor positive breast cancer is the most common type of breast cancer, comprising 70-80% of all breast cancers. Endocrine therapy is the main type of initial treatment for patients with your type of breast cancer. Endocrine therapy is treatment that tries to remove, or block certain hormones from binding to the cancer cells and thus slow or stop the growth of cancer. Although most patients with your type of breast cancer respond initially to endocrine therapies, it can lose its effectiveness. New therapies for this type of cancer are needed.
Detailed Description Endocrine therapy forms the backbone of treatment for both early stage and advanced stage hormone receptor positive breast cancer. Although most patients with advanced estrogen receptor positive metastatic disease respond initially to endocrine therapies, this response is short lived. New therapies able to provide additional benefit to patients with hormone receptor positive, endocrine-resistant, advanced metastatic breast cancer are required. This study proposes to add lapatinib to endocrine therapy to treat hormone receptor positive HER-2 negative metastatic breast cancer patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE Drug: lapatinib
lapatinib 1500 mg PO daily
Other Name: Tykerb
Study Arms  ICMJE Experimental: Lapatinib
Intervention: Drug: lapatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 17, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2008)
Actual Study Completion Date  ICMJE August 20, 2018
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Histologically or cytologically confirmed invasive breast cancer, which at time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease. Histological confirmation of recurrent/metastatic disease is encouraged but not required if clinical evidence of stage IV disease recurrence is available.
  • ER and/or Progesterone Receptor (PgR )positive breast cancer (10% or more of infiltrating cancer cells exhibit nuclear staining for ER and/or PgR)
  • Have had progressive disease or development of new metastatic disease while on treatment or within 12 months of treatment with an aromatase inhibitor and/or Fulvestrant in adjuvant or metastatic setting
  • Have measurable (defined as at least 1 lesion that can be accurately measured in at least 1 dimension [longest diameter to be recorded], with minimum lesion size ≥ 2cm on conventional measurement techniques or ≥ 1cm on spiral computed tomography [CT] scan), or evaluable disease. Patients with lytic or blastic bone disease as only site of disease will be eligible for the study. These patients will be evaluable for progression but not for response.
  • Primary tumor was HER-2 negative (IHC 0 or IHC 1+/2+ and Fluorescence in situ hybridization [FISH] ≤ 1.9)
  • Patients could have received prior Tamoxifen either as adjuvant therapy or for stage IV disease
  • Performance status of 2 or better per Eastern Cooperative Oncology Group (ECOG) criteria
  • Adequate cardiac function (cardiac ejection fraction ≥ 50% as measured by echocardiogram or multigated acquisition (MUGA) scan).
  • IV bisphosphonate and denosumab for bony metastatic disease will be allowed
  • Palliative radiation therapy to bony metastases will be allowed
  • Adequate bone marrow function per good medical practice. Results of these tests do not determine eligibility. Minor deviations are acceptable if they do not impact safety in the judgment of the treating physician. Absolute neutrophil count (ANC) ≥ 1500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 10 g/dL
  • Adequate kidney function: serum creatinine of ≤ 1.5mg/dl and/or creatinine clearance of ≥ 60 mL/min
  • Adequate hepatic function: transaminases < 2 x upper limit of normal and total bilirubin ≤ 1.5 mg/dL.
  • Must have a serum albumin ≥ 3.0 g/dL.
  • Must be informed of investigational nature of study and must sign informed consent in accordance with institutional rules.
  • Pretreatment lab values must be performed within 14 days of patient registration and other baseline studies within 30 days.
  • Patients will have a baseline bone scan, Computerized Tomography (CT) chest, abdomen and pelvis or Positron Emission Tomography (PET)/CT.
  • If previously treated brain metastasis and free of central nervous system (CNS) symptoms and > 3 months from treatment of brain metastasis are eligible

Exclusion Criteria

  • Prior HER-2 targeted therapy for metastatic disease
  • Has uncontrolled brain metastasis or leptomeningeal disease
  • Has rapidly progressing and/or bulky disease which in the opinion of the investigator may be more appropriately treated with a chemotherapy-based strategy.
  • Has an uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements.
  • Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
  • Patients with 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 (eg, Crohn's, ulcerative colitis).
  • Current active hepatic or biliary disease (exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • Renal function as measured by creatinine clearance <3 0ml/min (ratio to norm < 0.1)
  • HIV-positive patients receiving combination antiretroviral therapy
  • Pregnant women
  • Active cardiac disease defined as:

    • History of uncontrolled or symptomatic angina
    • History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
    • Myocardial infarction < 6 months from study entry
    • Uncontrolled or symptomatic congestive heart failure
    • Ejection fraction below institutional normal limit
    • Any other cardiac condition, which in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient
  • History of another primary cancer, with exception of:

    • curatively resected nonmelanomatous skin cancer
    • curatively treated cervical carcinoma in-situ
    • other primary solid tumor curatively resected treated with no known active disease present and no treatment administered for the last 3 years.
  • Life expectancy of < 2 months
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00759642
Other Study ID Numbers  ICMJE 11495
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Priyanka Sharma, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP