Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00343759
First received: June 21, 2006
Last updated: November 19, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Lapatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lapatinib
    Patients will take 14 days of Lapatinib prior to definitive surgery.
  Eligibility

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

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.
  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: NCT00343759

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

No publications provided

Responsible Party: Angela DeMichele, M.D., University of Pennsylvania Abramson Cancer Center
ClinicalTrials.gov Identifier: NCT00343759     History of Changes
Other Study ID Numbers: 803893, UPCC 12104
Study First Received: June 21, 2006
Last Updated: November 19, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014