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

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

ClinicalTrials.gov Identifier: NCT01698918

Novartis Reference Number: CRAD001Y24135

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Hormone Receptor Positive Breast Cancer
Phase 
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
202 participants
Start date 
Mar 07, 2013
Completion date 
Sep 30, 2020
Gender 
Female
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Everolimus
Everolimus will be self-administered as a daily dose of 10mg (two 5mg tablets) taken orally continuously from study day 1 until progression of disease, unacceptable toxicity or withdrawal of consent. Everolimus should be taken at the same time every day. Everolimus tablets should be swallowed whole with a glass of water once daily, either consistently with food or consistently without food. Tablets should not be chewed or crushed.
Drug
Letrozole
1st line study treatment: Letrozole will be self administered as a daily dose of 2.5mg continuously from study day 1 until disease progression, unacceptable toxicity or withdrawal of consent and should be taken at the same time every day, consistently with or without food. Everolimus and letrozole tablets should be taken together.
Drug
Exemestane
2nd Line Study Treatment: If patients progress on everolimus + letrozole, patients will be offered everolimus + exemestane. Exemestane will be self administered as a daily dose of 25mg taken orally continuously until disease progression, unacceptable toxicity or withdrawal of consent and should be taken at the same time every day after a meal. Everolimus and exemestane tablets should be taken together.
Drug
Alcohol-free dexamethasone mouth rinse
At the onset of symptoms suggestive of stomatitis patients must contact the study site. Upon confirmation of stomatitis at the site, patients in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution is commercially available will be randomly assigned to take either dexamethasone 0.5 mg/5ml mouth rinse or the standard of care used to treat stomatitis at the patient's center. The mouth rinse will be self administered at a daily dose of 10ml 3 times per day. Patients will be instructed to swish and expectorate the mouth rinse. Patients will also be instructed to fill out the Oral Stomatitis Daily Questionnaire (OSDQ) at home every day until the patient recovers. The mouth rinse will be self administered at a daily dose of 10ml 3 times per day.Patients will be instructed to swish and expectorate the mouth rinse.

Eligibility 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

Study Locations

United States
University of Alabama Comprehensive Cancer Center SC-2
-
Birmingham, 35294
Alabama
United States
Banner MD Anderson Cancer Center
-
Gilbert, 85234
Arizona
United States
Loma Linda University Loma Linda
-
Loma Linda, 92354
California
United States
Breastlink Medical Group Dept. of BreastlinkResearchGrp
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Long Beach, 90806
California
United States
Oncology Specialists, SC Advocate Medical Group-Niles
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Park Ridge, 60068-0736
Illinois
United States
St. Francis Health Comprehensive Cancer Center
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Topeka, 66606-169
Kansas
United States
Norton Healthcare, Inc. SC
-
Louisville, 40202
Kentucky
United States
Baystate Medical Center SC
-
Springfield, 00119
Massachusetts
United States
Saint Barnabas Medical Center CancerCenter of Saint Barnabas
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Livingston, 07039
New Jersey
United States
University of New Mexico Hospital SC
-
Albuquerque, 87106
New Mexico
United States
Broome Oncology SC
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Johnson City, 13790
New York
United States
Columbia University Medical Center- New York Presbyterian Columbia
-
New York, 10032
New York
United States
Cone Health Cancer Center
-
Greensboro, 27403
North Carolina
United States
East Texas Hematology Clinic SC
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Lufkin, 75904
Texas
United States
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
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Salt Lake City, 84106
Utah
United States
Argentina
Novartis Investigative Site
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Santa Rosa, 6300
La Pampa
Argentina
Novartis Investigative Site
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Rosario, S2000KZE
Santa Fe
Argentina
Brazil
Novartis Investigative Site
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Porto Alegre, 90035-003
RS
Brazil
Novartis Investigative Site
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Sao Paulo, 01317-002
SP
Brazil
Novartis Investigative Site
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Sao Paulo, 03102-002
SP
Brazil
France
Novartis Investigative Site
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Besancon cedex, 25030
-
France
Novartis Investigative Site
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Bordeaux, 33076
-
France
Novartis Investigative Site
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Hyères, 83400
-
France
Novartis Investigative Site
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Le Chesnay, 78157
-
France
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Lyon Cedex, 69373
-
France
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Nancy, 54000
-
France
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Nantes Cedex, 44277
-
France
Hungary
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Kecskemet, 6000
Bacs Kiskun
Hungary
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Gyula, 5700
-
Hungary
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Szekszard, 7100
-
Hungary
Japan
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Nagoya-city, 467-8602
Aichi
Japan
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Sapporo-city, 003-0804
Hokkaido
Japan
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Shiwa-gun, 028-3695
Iwate
Japan
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Kawasaki-city, 216-8511
Kanagawa
Japan
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Kumamoto City, 860-8556
Kumamoto
Japan
Korea, Republic of
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Seoul, 01812
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Korea, Republic of
Novartis Investigative Site
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Seoul, 06273
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Korea, Republic of
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Seoul, 06351
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Korea, Republic of
Netherlands
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Maastricht, 5800
AZ
Netherlands
Portugal
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Lisboa, 1400-038
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Portugal
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Lisboa, 1649-035
-
Portugal
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Porto, 4200-072
-
Portugal
Spain
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Salamanca, 37007
Castilla Y Leon
Spain
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Valencia, 46010
Comunidad Valenciana
Spain
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La Coruna, 15006
Galicia
Spain
Thailand
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Bangkok, 10330
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Thailand
Novartis Investigative Site
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Bangkok, 10400
-
Thailand
Novartis Investigative Site
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Bangkok, 10700
-
Thailand
Turkey
Novartis Investigative Site
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Antalya, 07059
-
Turkey
Novartis Investigative Site
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Istanbul, 34303
-
Turkey
Novartis Investigative Site
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Izmir, 35040
-
Turkey
United Kingdom
Novartis Investigative Site
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Bath, BA1 3NG
-
United Kingdom

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