Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted 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: NCT00343759
Recruitment Status : Withdrawn
First Posted : June 23, 2006
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The purpose of this study is to see what kinds of breast tumors will respond to lapatinib. Lapatinib is an experimental medicine which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Lapatinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2006
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Lapatinib
    Patients will take 14 days of Lapatinib prior to definitive surgery.

Primary Outcome Measures :
  1. Change in downstream effector levels in biologic responders to lapatinib as determined by degree of change in proliferation and apoptosis compared to biologic non-responders. [ Time Frame: Study completion ]

Secondary Outcome Measures :
  1. To describe the biologic response rate, defined by induction of apoptosis, to Lapatinib in a pre-surgical, treatment-naïve breast cancer population. [ Time Frame: Study completion ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically or cytologically-confirmed by either core or fine needle biopsy primary invasive carcinoma of the breast;
  • AJCC T2-T3 disease (>2.0 cm without chest wall or skin invasion) by at least one imaging modality (either mammogram, ultrasound, or MRI) - entry criteria is based on radiologic staging and not final pathologic staging;
  • ECOG performance status 0-1 (Karnofsky ≥ 70%
  • Any lymph node status, hormone receptor status, and level of erbB2 expression
  • No prior chemotherapy, hormonal therapy or radiation therapy to the affected breast for current or previous malignancy;
  • Cardiac ejection fraction >50% or within the institutional range of normal;
  • Patients must have normal organ and marrow function defined as: Leukocyte count >3000/uL; Absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets > 100,000/mm3, and hemoglobin ≥ 8 gm/dl; Serum creatinine ≤ 1.5 times ULN, or 24-hour creatinine clearance ≥ 75 cc/min; Serum bilirubin ≤ 1.5 times ULN; SGOT ≤ 2.5 times ULN; alkaline phosphatase ≤ 2.5 ULN times ULN.
  • The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Ability to understand and the willingness to sign written informed consent document.

Exclusion Criteria:

  • AJCC T1, T4, or stage 4 disease;
  • Patients may not have undergone incisional or excisional biopsy of their tumor;
  • Patients may not be receiving any other investigational agents;
  • Absolute contraindication to MRI imaging (cardiac pacemaker or any non-removable metallic foreign object in the body);
  • On chronic therapy with any known inducer or inhibitor of CYP3A4
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or lactating women are excluded from this study because lapatinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects.

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): NCT00343759

United States, Pennsylvania
Abramson Cancer Center of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: Angela DeMichele, M.D. University of Pennsylvania

Responsible Party: University of Pennsylvania Identifier: NCT00343759     History of Changes
Other Study ID Numbers: 803893
UPCC 12104
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Keywords provided by University of Pennsylvania:
Breast cancer
Tyrosine kinase inhibitors
Biologic response modifiers
Magnetic resonance imaging
Treatment-naive, operable

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action