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Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hormone Receptor Positive Breast Cancer

Intervention: Everolimus (Drug); Letrozole (Drug); Exemestane (Drug); Alcohol-free dexamethasone mouth rinse (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

The purpose of this study is to find out if combining everolimus with letrozole is safe and has beneficial effects in postmenopausal women who have estrogen positive HER2 negative locally advanced or metastatic breast cancer. Additionally, this study aims to find out if everolimus plus exemestane is safe and has beneficial effects in women with estrogen positive locally advanced or metastatic breast cancer after treatment with everolimus plus letrozole. This study will also aim to find out if a mouth rinse can help reduce the severity of oral stomatitis, a common side effect of everolimus. This part of the study will be conducted only in countries where an alcohol free 0. 5mg/5ml dexamethasone oral solution is commercially available.

Clinical Details

Official title: An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive HER2 Negative Metastatic or Locally Advanced Breast Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of patients progression-free after completion of 1st line treatment (everolimus + letrozole)

Secondary outcome:

Overall response rate and clinical benefit rate in patients receiving the first line study treatment (everolimus + letrozole)

Percentage of patients progression-free after completion of 2nd line treatment (everolimus + exemestane)

Overall survival of patients receiving first line study treatment (everolimus + letrozole)

Reduction in severity and duration of oral stomatitis

Assessment of safety based on the frequency of adverse events that fall outside normal pre-specified ranges

Overall response rate and clinical benefit rate in patients receiving the second line study treatment (everolimus + exemestane)

Reduction in severity and duration of oral stomatitis

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Patients 18 years old or greater

- Patients with metastatic or locally advanced, unresectable breast cancer not amenable

to curative treatment by surgery or radiotherapy

- Histological or cytological confirmation of estrogen-receptor positive (ER+) human

epidermal growth factor receptor 2 negative (HER2-) breast cancer

- Postmenopausal women

- No prior treatment for metastatic breast cancer

Exclusion Criteria:

- Patients with only non-measurable lesions other than bone metastases (e. g., pleural

effusion, ascites, etc)

- Patients who have received prior hormonal or any other systemic therapy for

metastatic breast cancer.

- Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the

case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.

- Previous treatment with mTOR inhibitors.

- Known hypersensitivity to mTOR inhibitors, e. g., sirolimus (rapamycin).

- Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigative Site, Besançon cedex 25030, France

Novartis Investigative Site, Bordeaux 33076, France

Novartis Investigative Site, Hyères 83400, France

Novartis Investigative Site, Le Chesnay 78157, France

Novartis Investigative Site, Lyon Cedex 69373, France

Novartis Investigative Site, Nancy 54000, France

Novartis Investigative Site, Nantes cedex 2 44202, France

Novartis Investigative Site, Gyula 5700, Hungary

Novartis Investigative Site, Kaposvar 7400, Hungary

Novartis Investigative Site, Kecskemet 6000, Hungary

Novartis Investigative Site, Kistarcsa 2143, Hungary

Novartis Investigative Site, Szekszard 7100, Hungary

Novartis Investigative Site, Seoul 135-720, Korea, Republic of

Novartis Investigative Site, Seoul 139-706, Korea, Republic of

Novartis Investigative Site, Maastricht 5800, Netherlands

Novartis Investigative Site, Lisboa 1400-038, Portugal

Novartis Investigative Site, Lisboa 1649-035, Portugal

Novartis Investigative Site, Porto 4200-072, Portugal

Novartis Investigative Site, Bangkok 10330, Thailand

Novartis Investigative Site, Bangkok 10400, Thailand

Novartis Investigative Site, Bangkok 10700, Thailand

Novartis Investigative Site, Altunizade 34662, Turkey

Novartis Investigative Site, Antalya 07059, Turkey

Novartis Investigative Site, Istanbul 34303, Turkey

Novartis Investigative Site, Izmir 35040, Turkey

Novartis Investigative Site, Bath BA1 3NG, United Kingdom

Novartis Investigative Site, Nagoya-city, Aichi 467-8602, Japan

University of Alabama Comprehensive Cancer Center SC-2, Birmingham, Alabama 35294, United States

Banner MD Anderson Cancer Center, Gilbert, Arizona 85234, United States

Novartis Investigative Site, Caba, Buenos Aires C1181ACH, Argentina

Loma Linda University Loma Linda, Loma Linda, California 92354, United States

Breastlink Medical Group Dept. of BreastlinkResearchGrp, Long Beach, California 90806, United States

Novartis Investigative Site, Salamanca, Castilla y Leon 37007, Spain

Novartis Investigative Site, Valencia, Comunidad Valenciana 46010, Spain

Novartis Investigative Site, La Coruna, Galicia 15006, Spain

Novartis Investigative Site, Sapporo, Hokkaido, Japan

Oncology Specialists, SC Dept.of Oncology Specialists, Park Ridge, Illinois 60068-0736, United States

Novartis Investigative Site, Morioka-city, Iwate 020-8505, Japan

Novartis Investigative Site, Kawasaki-city, Kanagawa 216-8511, Japan

St. Francis Health Comprehensive Cancer Center, Topeka, Kansas 66606-169, United States

Norton Healthcare, Inc. SC, Louisville, Kentucky 40202, United States

Novartis Investigative Site, Seoul, Korea 135-710, Korea, Republic of

Novartis Investigative Site, Kumamoto City, Kumamoto 860-8556, Japan

Novartis Investigative Site, Santa Rosa, La Pampa 6300, Argentina

Holy Cross Hospital Holy Cross, Silver Spring, Maryland 20910, United States

Baystate Medical Center SC, Springfield, Massachusetts 00119, United States

Novartis Investigative Site, Posadas, Misiones 3300, Argentina

Mercy Medical Research Institute SC, Manchester, Missouri 63021, United States

Saint Barnabas Medical Center CancerCenter of Saint Barnabas, Livingston, New Jersey 07039, United States

University of New Mexico Hospital SC, Albuquerque, New Mexico 87106, United States

Broome Oncology SC, Johnson City, New York 13790, United States

Columbia University Medical Center- New York Presbyterian Columbia, New York, New York 10032, United States

Cone Health Cancer Center, Greensboro, North Carolina, United States

Marion L. Shepard Cancer Center SC, Washington, North Carolina 27889, United States

Novartis Investigative Site, Porto Alegre, RS 90035-903, Brazil

Novartis Investigative Site, São Paulo, SP 01317-904, Brazil

Novartis Investigative Site, São Paulo, SP 03102-002, Brazil

Novartis Investigative Site, Rosario, Santa Fe S2000KZE, Argentina

East Texas Hematology Clinic SC, Lufkin, Texas 75904, United States

Utah Cancer Specialists Dept.of Utah Cancer Spec. (3), Salt Lake City, Utah 84106, United States

Additional Information

Starting date: March 2013
Last updated: April 22, 2015

Page last updated: August 23, 2015

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