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Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer

NCT00426556•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer. Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female or male patients ≥ 18 years old with WHO performance status ≤ 1
•HER-2 over-expressing metastatic breast cancer cells confirmed by histology
•Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy (phase l)
•Patient resistance to trastuzumab and taxanes (Phase ll)
•Measurable disease according to RECIST (Phase ll)
•Patients neurologically stable with adequate bone marrow, liver and renal function

Exclusion Criteria

•Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start
•Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start
•Patients who have previously received mTOR inhibitors

Locations (20)

Wilshire Oncology Medical Group La Verne

*see Various Departments*, California, United States

Compassionate Cancer Care Medical Group Dept.ofCCCMG

Fountain Valley, California, United States

Loma Linda University Dept.ofLomaLindaCancerCent(3)

Loma Linda, California, United States

University of California at Los Angeles Dept.of UCLA Dept.ofMed.

Los Angeles, California, United States

Florida Cancer Research Institute

Davie, Florida, United States

Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

Atlanta, Georgia, United States

North Shore University Health System

Evanston, Illinois, United States

Peninsula Regional Medical Center Deptof Oncology and Hematology

Salisbury, Maryland, United States

Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CRAD001J2101

St Louis, Missouri, United States

Cancer Centers of the Carolinas CC of C -Eastside

Greenville, South Carolina, United States

Key Dates

Start Date

July 1, 2007

Primary Completion Date

March 1, 2014

Completion Date

March 1, 2014

Last Updated

December 28, 2015

Enrollment

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

Everolimus

DRUG

Trastuzumab

DRUG

Paclitaxel

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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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: December 28, 2015Data 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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Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer

A Study of Surgery and Radiotherapy in People With Breast Cancer