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A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01272141
Recruitment Status : Terminated (Slow accrual, Funding stopped)
First Posted : January 7, 2011
Results First Posted : September 10, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
William Read, Emory University

Tracking Information
First Submitted Date  ICMJE January 6, 2011
First Posted Date  ICMJE January 7, 2011
Results First Submitted Date  ICMJE September 3, 2014
Results First Posted Date  ICMJE September 10, 2014
Last Update Posted Date September 22, 2014
Study Start Date  ICMJE December 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2014)
  • Overall Response Rate Will Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Tumor Assessment for All Lesions Must be Performed Every Eight Weeks While on Study by CT Scan. [ Time Frame: Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study. ]
  • The Safety and Toxicity of the Combination Therapy of Lapatinib and Everolimus Will be Monitored Using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 3.0. The Incidence of Any Grade 3 or 4 Toxicities Will be Analyzed. [ Time Frame: Safety assessments will be performed every four weeks while the patient remains on study. ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2011)
  • Overall Response rate will measured using RECIST criteria. Tumor assessment for all lesions must be performed every eight weeks while on study by CT scan. [ Time Frame: Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study. ]
  • The safety and toxicity of the combination therapy of lapatinib and everolimus will be monitored using the NCI CTCAE v. 3.0. The incidence of any Grade 3 or 4 toxicities will be analyzed. [ Time Frame: Safety assessments will be performed every four weeks while the patient remains on study. ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer
Official Title  ICMJE Phase II Trial of Lapatinib in Combination With Everolimus in Triple Negative Metastatic or Locally Advanced Breast Cancer
Brief Summary The patient is being asked to join this clinical research study to find out if lapatinib, an agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface of cancer cells in combination with everolimus, an agent that targets a protein in the cancer cell, called mammalian target of rapamycin (mTOR) is effective in metastatic triple negative breast cancers that are no longer controlled by standard chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasms
  • Breast Cancer
  • Cancer of the Breast
Intervention  ICMJE Drug: Lapatinib and Everolimus

Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily

Other Names:
  • Lapatinib
  • Tykerb
  • Everolimus
  • Affinitor
Study Arms  ICMJE Experimental: Arm A: Lapatinib plus Everolimus
Intervention: Drug: Lapatinib and Everolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 25, 2013)
5
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2011)
43
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed ER(-), PR(-), HER2(-) locally advanced or metastatic breast cancer
  • Disease progression following prior first line cytotoxic chemotherapy in metastatic setting
  • At least 1 lesion measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Age >18 years old
  • Female
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Left ventricular ejection fraction (LVEF) > 50%
  • Absolute neutrophil count (ANC)>1500/mm3; platelets >100,000/mm3; hemoglobin > 9 g/dL; serum creatinine < 1.5x upper limit of normal (ULN); total bilirubin < 1.5x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x ULN
  • Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
  • Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
  • Patients of childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

  • Patients with current active hepatic or biliary disease (except for patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • Patients with an active infection or with a fever > 101.3 Fahrenheit within 3 days of the first scheduled day of protocol treatment
  • Patients with active central nervous system (CNS) metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the trial
  • History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin or cervical intra-epithelial neoplasia with two consecutive normal pap smears 6 months apart
  • Patients who received radiotherapy to more than 25% of their bone marrow; or patients who received radiotherapy to target lesions within 4 weeks of entry
  • Patients who are receiving concurrent investigational therapy
  • Peripheral neuropathy >= Grade 2
  • Patients who are pregnant or lactating
  • Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
  • History of allogeneic transplant
  • Known HIV or Hepatitis B or C (active, previously treated or both)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01272141
Other Study ID Numbers  ICMJE IRB00031112
WCI1711-09 ( Other Identifier: Other )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Read, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Read, MD Emory University Winship Cancer Institute
PRS Account Emory University
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP