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A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT01272141•Emory University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+1 more criteria

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
+1 more criteria

Locations (3)

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory Midtown (Crawford Long Hospital)

Atlanta, Georgia, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Key Dates

Start Date

December 1, 2010

Primary Completion Date

January 1, 2013

Completion Date

January 1, 2014

Last Updated

September 22, 2014

Enrollment

ACTUAL participants

Conditions

Breast NeoplasmsBreast CancerCancer of the Breast

Interventions

Lapatinib and Everolimus

DRUG

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RECRUITINGPHASE1

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer