Breast Cancer Clinical Trial
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.
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.
This was an open-label, phase II, multicenter, international, single-arm study for postmenopausal women with ER+/HER2- metastatic or locally advanced breast cancer.
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.
Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
Histological or cytological confirmation of ER+/ HER2- breast cancer
No prior treatment for metastatic breast cancer
Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
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).
Other protocol-defined inclusion/exclusion criteria might apply
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There are 52 Locations for this study
Birmingham Alabama, 35294, United States
Gilbert Arizona, 85234, United States
Loma Linda California, 92354, United States
Long Beach California, 90806, United States
Park Ridge Illinois, 60068, United States
Topeka Kansas, 66606, United States
Louisville Kentucky, 40202, United States
Springfield Massachusetts, 01199, United States
Livingston New Jersey, 07039, United States
Albuquerque New Mexico, 87106, United States
Johnson City New York, 13790, United States
New York New York, 10032, United States
Greensboro North Carolina, 27403, United States
Lufkin Texas, 75904, United States
Salt Lake City Utah, 84106, United States
Santa Rosa La Pampa, 6300, Argentina
Rosario Santa Fe, S2000, Argentina
Porto Alegre RS, 90035, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 03102, Brazil
Besancon cedex , 25030, France
Bordeaux , 33076, France
HyÃ¨res , 83400, France
Le Chesnay , 78157, France
Lyon Cedex , 69373, France
Nancy , 54000, France
Nantes Cedex , 44277, France
Kecskemet Bacs Kiskun, 6000, Hungary
Gyula , 5700, Hungary
Szekszard , 7100, Hungary
Nagoya-city Aichi, 467-8, Japan
Sapporo-city Hokkaido, 003-0, Japan
Shiwa-gun Iwate, 028-3, Japan
Kawasaki-city Kanagawa, 216-8, Japan
Kumamoto City Kumamoto, 860-8, Japan
Seoul , 01812, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06351, Korea, Republic of
Maastricht AZ, 5800, Netherlands
Lisboa , 1400-, Portugal
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
Salamanca Castilla Y Leon, 37007, Spain
Valencia Comunidad Valenciana, 46010, Spain
La Coruna Galicia, 15006, Spain
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Antalya , 07059, Turkey
Istanbul , 34303, Turkey
Izmir , 35040, Turkey
Bath , BA1 3, United Kingdom
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