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

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
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 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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT01698918

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 52 Locations for this study

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University of Alabama Comprehensive Cancer Center SC-2
Birmingham Alabama, 35294, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Loma Linda University Loma Linda
Loma Linda California, 92354, United States
Breastlink Medical Group Dept. of BreastlinkResearchGrp
Long Beach California, 90806, United States
Oncology Specialists, SC Advocate Medical Group-Niles
Park Ridge Illinois, 60068, United States
St. Francis Health Comprehensive Cancer Center
Topeka Kansas, 66606, United States
Norton Healthcare, Inc. SC
Louisville Kentucky, 40202, United States
Baystate Medical Center SC-2
Springfield Massachusetts, 01199, 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, 27403, United States
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
Novartis Investigative Site
Santa Rosa La Pampa, 6300, Argentina
Novartis Investigative Site
Rosario Santa Fe, S2000, Argentina
Novartis Investigative Site
Porto Alegre RS, 90035, Brazil
Novartis Investigative Site
Sao Paulo SP, 01317, Brazil
Novartis Investigative Site
Sao Paulo SP, 03102, Brazil
Novartis Investigative Site
Besancon 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 , 44277, France
Novartis Investigative Site
Kecskemet Bacs Kiskun, 6000, Hungary
Novartis Investigative Site
Gyula , 5700, Hungary
Novartis Investigative Site
Szekszard , 7100, Hungary
Novartis Investigative Site
Nagoya-city Aichi, 467-8, Japan
Novartis Investigative Site
Sapporo-city Hokkaido, 003-0, Japan
Novartis Investigative Site
Shiwa-gun Iwate, 028-3, Japan
Novartis Investigative Site
Kawasaki-city Kanagawa, 216-8, Japan
Novartis Investigative Site
Kumamoto City Kumamoto, 860-8, Japan
Novartis Investigative Site
Seoul , 01812, Korea, Republic of
Novartis Investigative Site
Seoul , 06273, Korea, Republic of
Novartis Investigative Site
Seoul , 06351, Korea, Republic of
Novartis Investigative Site
Maastricht AZ, 5800, Netherlands
Novartis Investigative Site
Lisboa , 1400-, Portugal
Novartis Investigative Site
Lisboa , 1649-, Portugal
Novartis Investigative Site
Porto , 4200-, Portugal
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
Bangkok , 10330, Thailand
Novartis Investigative Site
Bangkok , 10400, Thailand
Novartis Investigative Site
Bangkok , 10700, Thailand
Novartis Investigative Site
Antalya , 07059, Turkey
Novartis Investigative Site
Istanbul , 34303, Turkey
Novartis Investigative Site
Izmir , 35040, Turkey
Novartis Investigative Site
Bath , BA1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT01698918

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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