Status:
TERMINATED
Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Novartis Pharmaceuticals
GlaxoSmithKline
Conditions:
Breast Neoplasms
Endocrine Breast Diseases
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
About a third of patients with breast cancer are usually treated by hormone pills called tamoxifen and aromatase inhibitors. Aromatase inhibitors are drugs that stop female hormone production. Female ...
Detailed Description
This is a single-institution clinical trial. Patients will be stratified according to the HER2 status: Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue In the fi...
Eligibility Criteria
Inclusion
- Female greater than or equal to 18 years.
- Histologically confirmed breast adenocarcinoma with incurable progressing local-regional or metastatic.
- ER and/or PR positivity of primary and/or secondary tumor.
- Patients must have measurable or evaluable disease.
- Evidence of disease progression or relapse while on or less than 6 months off aromatase inhibitors or tamoxifen either in adjuvant or first line metastatic setting.
- Postmenopausal
- Patients may have received up to one prior chemotherapy regimen for stage IV breast cancer. Prior chemotherapy in the adjuvant and/or neoadjuvant setting is permitted. Chemotherapy must be finished at least 2 weeks prior to enrollment.
- ECOG performance status \<2
- Fasting cholesterol ≤300 mg/dL OR ≤7.75 mmol/LAND fasting triglycerides ≤ 2.5 x ULN despite appropriate treatment.
- Patients must have adequate organ function as defined by the protocol.
- Stratification 1:
- HER2 positive in the primary or secondary tumor tissue
- Prior trastuzumab therapy is allowed but NOT required. However, trastuzumab should be discontinued at least 3 weeks prior to enrollment.
- Stratification 2:
- HER2 negative in the primary or secondary tumor tissue
Exclusion
- Patients receiving any other investigational agents.
- Prior exposure to lapatinib, everolimus, or other mTOR inhibitors.
- History of allergic reactions or hypersensitivity to compounds similar to everolimus, lapatinib, or letrozole.
- Patients who have any severe and/or uncontrolled medical conditions that could affect their participation such as:
- Left ventricular ejection fraction (LVEF) \< 50%
- Unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.
- Severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is ≤ 88% at rest on room air.
- Uncontrolled diabetes
- Active or uncontrolled severe infection
- Patients with QTc interval \> 0.47 seconds.
- Significant chronic or acute gastrointestinal disorder with diarrhea as a major symptom.
- Prior exposure to more than 360 mg/m2 doxorubicin, more than 120 mg/m2mitoxantrone, or more than 90 mg/m2idarubicin, or elevated baseline cardiac troponin I.
- Patients with active CNS metastasis and/or carcinomatous meningtitis. However, patients with CNS metastasis who have completed a therapy and are clinically stable for 3 weeks as defined as: (1) no evidence of new or enlarging CNS metastasis and (2) off steroids and/or anticonvulsants.
- Patient is known to be HIV, Hepatitis B, or Hepatitis C-positive (these tests are not required).
- Patients with current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease).
- Patients with INR ≥ 2 or PTT ≥ 2 x upper normal limit.
- Previous or current systemic malignancy other than breast cancer within the past 3 years other than carcinoma in situ of the cervix or basal/squamous carcinoma of the skin.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01499160
Start Date
May 1 2012
End Date
December 1 2016
Last Update
February 11 2022
Active Locations (1)
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1
University of Maryland Marlene & Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201