Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
NCT ID: NCT01698918
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
202 participants
INTERVENTIONAL
2013-03-07
2021-01-13
Brief Summary
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Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.
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Detailed Description
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This study was comprised of 2 phases:
\- Core Phase: from first participant first visit to 24 months after enrollment of the last participant (and upon approval of amendment 5 dated 14-Feb-2017), up to approximately 4 years. The main purpose of the amendment 5 was to implement an Extension Phase up to 3 years.
During the core phase, all enrolled participants received everolimus in combination with letrozole in the first line setting until disease progression or any other reason for which the participant might be discontinued. Only those participants who had disease progression in the first line setting were offered second line treatment (everolimus in combination with exemestane). Participants who discontinued first line treatment due to reasons other than disease progression were not eligible for second line treatment. The participants who were treated in the second line setting continued treatment until disease progression, unacceptable toxicity or withdrawal of consent.
\- Extension Phase: Participants that were still benefiting from everolimus at the end of the Core Phase (and upon approval of amendment 5 dated 14-Feb-2017) were transitioned to the Extension phase of the study. Participants were continued on their existing line of treatment (everolimus plus letrozole or everolimus plus exemestane) in the extension, up to 3 years or until progression or any other reason for which the participant might be discontinued. Participants entering the Extension Phase on first line treatment and deemed to no longer be clinically benefiting were not offered second line treatment in the context of the study
This study included a randomized, open-label sub-study for participants in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution was commercially available who experienced a stomatitis event: at the first onset of symptoms suggestive of stomatitis, participants were to contact the study site and based on preliminary confirmation of diagnosis, participants were asked to visit the study site within 24 hours. Upon confirmation of stomatitis, participants in countries where the alcohol-free 0.5 mg/5 mL dexamethasone oral solution was commercially available (US sites only) were randomly assigned in a 1:1 ratio to take either 0.5 mg/5 mL dexamethasone mouth rinse or the standard of care used to treat stomatitis at the participant's center.
All participants who experienced stomatitis (regardless of inclusion in the sub-study) were instructed to fill out the Oral Stomatitis Daily Questionnaire (OSDQ) at home every day until the participant recovered. For subsequent episodes of stomatitis, participants were instructed to contact the physician. If part of the randomized set upon telephone confirmation, they were instructed to utilize the same treatment they were assigned to after the first episode and complete the OSDQ booklet.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Everolimus+letrozole/exemestane (first line and second line treatment)
Participants received everolimus in combination with letrozole as first-line treatment. Only participants who had disease progression in the first line setting (core phase) were offered second-line treatment (everolimus in combination with exemestane)
Everolimus
Everolimus was self-administered as a daily dose of 10mg (two 5mg tablets) taken orally continuously until progression of disease, unacceptable toxicity or withdrawal of consent.
Letrozole
1st line study treatment: Letrozole was self administered as a daily dose of 2.5mg continuously until disease progression or any other reason for which the patient might be discontinued
Exemestane
2nd Line Study Treatment: Exemestane was self administered as a daily dose of 25mg taken orally continuously until disease progression or any other reason for which the patient might be discontinued
Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study)
Alcohol-free 0.5mg/5ml dexamethasone oral solution was self-administered at a daily dose of 10ml 3 times per day (participants with confirmed stomatitis who entered the stomatitis sub-study).
Standard of care to treat stomatitis (Stomatitis sub-study)
Standard of care used to treat stomatitis at the patient's center (participants with confirmed stomatitis who entered the stomatitis sub-study).
Interventions
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Everolimus
Everolimus was self-administered as a daily dose of 10mg (two 5mg tablets) taken orally continuously until progression of disease, unacceptable toxicity or withdrawal of consent.
Letrozole
1st line study treatment: Letrozole was self administered as a daily dose of 2.5mg continuously until disease progression or any other reason for which the patient might be discontinued
Exemestane
2nd Line Study Treatment: Exemestane was self administered as a daily dose of 25mg taken orally continuously until disease progression or any other reason for which the patient might be discontinued
Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study)
Alcohol-free 0.5mg/5ml dexamethasone oral solution was self-administered at a daily dose of 10ml 3 times per day (participants with confirmed stomatitis who entered the stomatitis sub-study).
Standard of care to treat stomatitis (Stomatitis sub-study)
Standard of care used to treat stomatitis at the patient's center (participants with confirmed stomatitis who entered the stomatitis sub-study).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological or cytological confirmation of ER+/ HER2- breast cancer
* Postmenopausal women
* No prior treatment for metastatic breast cancer
Exclusion Criteria
* Patients who had received prior hormonal or any other systemic therapy for metastatic breast cancer. Patients might 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).
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Alabama Comprehensive Cancer Center SC-2
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Loma Linda University Loma Linda
Loma Linda, California, United States
Breastlink Medical Group Dept. of BreastlinkResearchGrp
Long Beach, California, United States
Oncology Specialists, SC Advocate Medical Group-Niles
Park Ridge, Illinois, United States
St. Francis Health Comprehensive Cancer Center
Topeka, Kansas, United States
Norton Healthcare Inc SC
Louisville, Kentucky, United States
Baystate Medical Center SC-2
Springfield, Massachusetts, United States
Saint Barnabas Medical Center CancerCenter of Saint Barnabas
Livingston, New Jersey, United States
University of New Mexico Hospital SC
Albuquerque, New Mexico, United States
Broome Oncology SC
Johnson City, New York, United States
Columbia University Medical Center- New York Presbyterian Columbia
New York, New York, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
East Texas Hematology Clinic SC
Lufkin, Texas, United States
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
Salt Lake City, Utah, United States
Novartis Investigative Site
Santa Rosa, La Pampa Province, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Besançon, , France
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Hyères, , France
Novartis Investigative Site
Le Chesnay, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Nancy, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Kecskemét, Bács-Kiskun county, Hungary
Novartis Investigative Site
Gyula, , Hungary
Novartis Investigative Site
Szekszárd, , Hungary
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Shiwa-gun, Iwate, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Kumamoto, Kumamoto, Japan
Novartis Investigative Site
Maastricht, AZ, Netherlands
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
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Porto, , Portugal
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Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
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Seoul, , South Korea
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
A Coruña, Galicia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Antalya, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Bath, , United Kingdom
Countries
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References
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Royce M, Bachelot T, Villanueva C, Ozguroglu M, Azevedo SJ, Cruz FM, Debled M, Hegg R, Toyama T, Falkson C, Jeong J, Srimuninnimit V, Gradishar WJ, Arce C, Ridolfi A, Lin C, Cardoso F. Everolimus Plus Endocrine Therapy for Postmenopausal Women With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: A Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):977-984. doi: 10.1001/jamaoncol.2018.0060.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-003065-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001Y24135
Identifier Type: -
Identifier Source: org_study_id
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