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

This study has been terminated.
(Slow accrual, Funding stopped)
Sponsor:
Information provided by (Responsible Party):
William Read, Emory University
ClinicalTrials.gov Identifier:
NCT01272141
First received: January 6, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Breast Cancer
Cancer of the Breast
Drug: Lapatinib and Everolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Lapatinib in Combination With Everolimus in Triple Negative Metastatic or Locally Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: December 2010
Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Lapatinib plus Everolimus Drug: Lapatinib and Everolimus

Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily

Other Names:
  • Lapatinib
  • Tykerb
  • Everolimus
  • Affinitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 RECIST criteria
  • Age >18 years old
  • Female
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Left ventricular ejection fraction (LVEF) > 50%
  • ANC>1500/mm3; platelets >100,000/mm3; hemoglobin > 9 g/dL; serum creatinine < 1.5X ULN; total bilirubin < 1.5X ULN, AST and 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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272141

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30329
Emory Midtown (Crawford Long Hospital)
Atlanta, Georgia, United States, 30308
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: William I Read, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: William Read, MD, Emory University
ClinicalTrials.gov Identifier: NCT01272141     History of Changes
Other Study ID Numbers: IRB00031112, WCI1711-09
Study First Received: January 6, 2011
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Emory University:
Metastatic breast cancer
Triple negative breast cancer
ER/PR/HER2-negative breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Everolimus
Sirolimus
Lapatinib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014