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Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.

Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With ErbB2- (HER2/Neu-) Overexpressing Invasive Breast Cancer

NCT00524303•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Have signed an informed consent form (ICF) and a Patient Authorization Form (HIPAA).
•Have histologically or cytologically confirmed ErbB2- (HER2/neu-) overexpressing invasive breast cancer (T2-4, N0-2).
•ErbB2 overexpressing breast cancer, defined as one of the following definitions:
•3+ staining by immunohistochemistry (IHC),
•a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus
•a FISH ratio of more than 2.2.
•Have either measurable or evaluable disease.
•Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 (Refer to Section 11.4).
•Have LVEF within the institutional range of normal as measured by either echocardiogram (ECHO) or MUGA scans. The same modality must be used consistently throughout the study.
•Be deemed able to tolerate 8 cycles of preoperative chemotherapy, including 4 cycles with an anthracycline (epirubicin).
+17 more criteria

Exclusion Criteria

•Have received any prior chemotherapy.
•Had prior therapy with an ErbB1 and/or ErbB2 inhibitor.
•Are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication.
•Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded.
•Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety.
•Have an active or uncontrolled infection.
•Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
•Have active cardiac disease, defined as one or more of the following:
•History of uncontrolled or symptomatic angina History of arrhythmias requiring medications, or clinically significant Myocardial infarction \<6 months from study entry Uncontrolled or symptomatic congestive heart failure Ejection fraction below the institutional normal limit Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
•Are pregnant or breastfeeding.
+5 more criteria

Locations (23)

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Hudson, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Austin, Texas, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

October 1, 2010

Completion Date

August 1, 2015

Last Updated

November 11, 2016

Enrollment

100

ACTUAL participants

Conditions

Neoplasms, Breast

Interventions

Trastuzumab

DRUG

Paclitaxel

DRUG

FEC75

DRUG

Lapatinib

DRUG

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

NCT04915755

Neoplasms, Breast

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COMPLETEDPHASE3

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

NCT00490139

Neoplasms, Breast

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TERMINATEDPHASE3

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients