Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy

Phase 2

Terminated

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: lapatinib

• Registration Number: NCT00759642
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

Hormone receptor positive breast cancer is the most common type of breast cancer, comprising 70-80% of all breast cancers. Endocrine therapy is the main type of initial treatment for patients with your type of breast cancer. Endocrine therapy is treatment that tries to remove, or block certain hormones from binding to the cancer cells and thus slow or stop the growth of cancer. Although most patients with your type of breast cancer respond initially to endocrine therapies, it can lose its effectiveness. New therapies for this type of cancer are needed.

Detailed Description

Endocrine therapy forms the backbone of treatment for both early stage and advanced stage hormone receptor positive breast cancer. Although most patients with advanced estrogen receptor positive metastatic disease respond initially to endocrine therapies, this response is short lived. New therapies able to provide additional benefit to patients with hormone receptor positive, endocrine-resistant, advanced metastatic breast cancer are required. This study proposes to add lapatinib to endocrine therapy to treat hormone receptor positive HER-2 negative metastatic breast cancer patients.

Study Timeline

• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Study Start: 2009-03
• Primary Completion: 2015-11
• Results First Submitted: 2017-04-17
• Results First Submitted QC: 2017-04-17
• Results First Posted: 2017-05-23
• Study Completion: 2018-08-20
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lapatinib	lapatinib	lapatinib

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	12 months	Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.

Trial Locations

Locations (3)

Truman Medical Center; 🇺🇸 Kansas City, Missouri, United States

Cotton-O-Neil Cancer Center (Stormont Vail Health Care); 🇺🇸 Topeka, Kansas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States