Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy
This study has been withdrawn prior to enrollment.
Information provided by:
University of Pennsylvania
First received: June 21, 2006
Last updated: November 19, 2008
Last verified: November 2008
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.
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|Abramson Cancer Center of University of Pennsylvania
|Philadelphia, Pennsylvania, United States, 19104 |
University of Pennsylvania
||Angela DeMichele, M.D.
||University of Pennsylvania
No publications provided
||Angela DeMichele, M.D., University of Pennsylvania Abramson Cancer Center
History of Changes
|Other Study ID Numbers:
||803893, UPCC 12104
|Study First Received:
||June 21, 2006
||November 19, 2008
||United States: Food and Drug Administration
Keywords provided by University of Pennsylvania:
Tyrosine kinase inhibitors
Biologic response modifiers
Magnetic resonance imaging
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Neoplasms by Site
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action