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Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Nancy Lin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00470704
First received: May 7, 2007
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Lapatinib
Drug: Herceptin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate the rate of objective response by RECIST to combination therapy with lapatinib and trastuzumab, in the first-line and second/third line settings. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate further the safety and toxicity of combined lapatinib plus trastuzumab [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To describe time to progression, site(s) of first progression, clinical benefit rate, and overall survival in patients treated with combined lapatinib plus trastuzumab. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lapatinib
    Oral dose taken daily
    Drug: Herceptin
    Given intravenously once a week or once every 3 weeks
    Other Name: trastuzumab
Detailed Description:
  • Participants will be asked to undergo a biopsy of an area of the body where the cancer has spread.
  • Participants will be given a study medication-dosing calendar for each treatment cycle. Each treatment cycle lasts four weeks during which time you will be taking lapatinib, once per day.
  • Participants will receive Herceptin once every week or once every 3 weeks through a vein.
  • During all treatment cycles a physical exam will be performed and questions about the participants general health will be asked. Blood tests including chemistry and hematology will be performed to measure additional effect of the study drug and disease status. Photographs may be taken of the tumor to assess the response of the tumor to treatment.
  • CT scans will be repeated every 8 weeks to assess the effect of the study treatment on the cancer. Either a MUGA scan or echocardiogram will be performed 8 weeks and 16 weeks after the participant starts the study treatment.
  • Participants will remain on this research study for as long as they are benefiting from the study treatment.
  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed invasive breast cancer, with stage IV disease
  • HER2-positive breast cancer, defined as 3+ staining by IHC or gene amplification by FISH
  • Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
  • Willingness to undergo a research biopsy of recurrent or metastatic disease
  • Prior chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry.
  • Completed radiation therapy at least 7 days prior to beginning protocol treatment
  • Cohort 1: No prior chemotherapy for advanced breast cancer; no prior trastuzumab in the advanced breast cancer setting; nor prior treatment with lapatinib or other HER2-directed therapy other than trastuzumab
  • Cohort 2: Up to two prior chemotherapy regimens for the treatment of advanced breast cancer; no prior treatment with lapatinib or other HER2-directed therapy except for trastuzumab
  • 18 years of age or older
  • Life expectancy of greater than 12 weeks
  • ECOG Performance Status 0-2
  • Normal organ and marrow function as outlined in protocol
  • Cardiac ejection fraction, as assessed by either MUGA scan or echocardiogram greater than or equal to 50%
  • Able to take oral medications

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents or concurrent chemotherapy or hormonal therapy for treatment of metastatic disease
  • Active brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in this study
  • Clinically significant malabsorption syndrome
  • Uncontrolled intercurrent illness
  • Pregnant or breastfeeding women
  • Concurrent use of the medications listed in the protocol because of possible interaction with lapatinib
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470704

Locations
United States, Alabama
University fo Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60452
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana-Farber at Faulkner Hospital
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nancy Lin, MD
GlaxoSmithKline
Investigators
Principal Investigator: Nancy Lin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Nancy Lin, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00470704     History of Changes
Other Study ID Numbers: 06-213
Study First Received: May 7, 2007
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
HER2-positive breast cancer
Herceptin
trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Lapatinib
Trastuzumab
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014