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

September 11, 2014 updated by: William Read, Emory University

Phase II Trial of Lapatinib in Combination With Everolimus in Triple Negative Metastatic or Locally Advanced Breast Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
      • Atlanta, Georgia, United States, 30329
        • Emory University Winship Cancer Institute
      • Atlanta, Georgia, United States, 30308
        • Emory Midtown (Crawford Long Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Lapatinib plus Everolimus
Drug: Lapatinib and Everolimus

Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily

Other Names:
  • Tykerb
  • Everolimus
  • Lapatinib
  • Affinitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
Safety assessments will be performed every four weeks while the patient remains on study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: William Read, MD, Emory University Winship Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00031112
  • WCI1711-09 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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