Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
This study is currently recruiting participants.
Verified December 2013 by University of Kansas
Information provided by (Responsible Party):
University of Kansas
First received: September 24, 2008
Last updated: December 19, 2013
Last verified: December 2013
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.
Metastatic Breast Cancer
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial of Lapatinib in Women With Hormone Receptor Positive (ER and/or PR +) HER-2 Negative Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
Primary Outcome Measures:
- Progression free survival [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
lapatinib 1500 mg PO daily
Other Name: Tykerb
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically or cytologically confirmed invasive breast cancer, which at time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease. Histological confirmation of recurrent/metastatic disease is encouraged but not required if clinical evidence of stage IV disease recurrence is available.
- ER and/or Progesterone Receptor (PgR )positive breast cancer (10% or more of infiltrating cancer cells exhibit nuclear staining for ER and/or PgR)
- Have had progressive disease or development of new metastatic disease while on treatment or within 12 months of treatment with an aromatase inhibitor and/or Fulvestrant in adjuvant or metastatic setting
- Have measurable (defined as at least 1 lesion that can be accurately measured in at least 1 dimension [longest diameter to be recorded], with minimum lesion size ≥ 2cm on conventional measurement techniques or ≥ 1cm on spiral computed tomography [CT] scan), or evaluable disease. Patients with lytic or blastic bone disease as only site of disease will be eligible for the study. These patients will be evaluable for progression but not for response.
- Primary tumor was HER-2 negative (IHC 0 or IHC 1+/2+ and FISH negative)
- Patients could have received prior Tamoxifen either as adjuvant therapy or for stage IV disease
- Performance status of 2 or better per Eastern Cooperative Oncology Group (ECOG) criteria
- Adequate cardiac function (cardiac ejection fraction ≥ 50% as measured by echocardiogram or multigated acquisition (MUGA) scan).
- IV bisphosphonate and denosumab for bony metastatic disease will be allowed
- Palliative radiation therapy to bony metastases will be allowed
- Adequate bone marrow function per good medical practice. Results of these tests do not determine eligibility. Minor deviations are acceptable if they do not impact safety in the judgment of the treating physician. Absolute neutrophil count (ANC) ≥ 1500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 10 g/dL
- Adequate kidney function: serum creatinine of ≤ 1.5mg/dl and/or creatinine clearance of ≥ 60 mL/min
- Adequate hepatic function: transaminases < 2 x upper limit of normal and total bilirubin ≤ 1.5 mg/dL.
- Must have a serum albumin ≥ 3.0 g/dL.
- Must be informed of investigational nature of study and must sign informed consent in accordance with institutional rules.
- Pretreatment lab values must be performed within 14 days of patient registration and other baseline studies within 30 days.
- Patients will have a baseline, bone scan, CT chest,abdomen and pelvis or PET/CT.
- If previously treated brain metastasis and free of central nervous system (CNS) symptoms and > 3 months from treatment of brain metastasis are eligible
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759642
|University of Kansas Medical Center
|Kansas City, Kansas, United States, 66160 |
|Contact: Priyanka Sharma, MD 913-588-0789 firstname.lastname@example.org |
|Sub-Investigator: Qamar Khan, MD |
|Sub-Investigator: Carol Fabian, MD |
|Sub-Investigator: Bruce Kimler, PhD |
|Cotton-O-Neil Cancer Center (Stormont Vail Health Care)
|Topeka, Kansas, United States, 66606 |
|Contact: Jyothi Dodlapati, MD 785-354-5300 |
|Principal Investigator: Jyothi Dodlapati, MD |
|Truman Medical Center
|Kansas City, Missouri, United States, 64108 |
|Contact: Hitendra Patel, MD 816-404-4045 |
|Principal Investigator: Hitendra Patel, MD |
University of Kansas
||Priyanka Sharma, MD
||University of Kansas
No publications provided
||University of Kansas
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2008
||December 19, 2013
||United States: Food and Drug Administration
United States: Institutional Review Board
Keywords provided by University of Kansas:
hormone receptor positive
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Neoplasms by Site
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action