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

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: NCT00470704
Recruitment Status : Active, not recruiting
First Posted : May 8, 2007
Last Update Posted : September 9, 2020
Information provided by (Responsible Party):
Nancy Lin, MD, Dana-Farber Cancer Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Lapatinib Drug: Herceptin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : May 14, 2007
Actual Primary Completion Date : April 27, 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Lapatinib and Herceptin
1000 mg daily Lapatinib and 2 mg/kg weekly or the 6 mg/kg every 3 week dose of trastuzumab
Drug: Lapatinib
Oral dose taken daily
Other Name: Tykerb

Drug: Herceptin
Given intravenously once a week or once every 3 weeks
Other Name: trastuzumab

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate further the safety and toxicity of combined lapatinib plus trastuzumab [ Time Frame: 3 years ]
  2. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00470704

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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 at Faulkner Hospital
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
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
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Principal Investigator: Nancy Lin, MD Dana-Farber Cancer Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nancy Lin, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute Identifier: NCT00470704    
Other Study ID Numbers: 06-213
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nancy Lin, MD, Dana-Farber Cancer Institute:
HER2-positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action