Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
NCT ID: NCT03176238
Last Updated: 2020-04-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
235 participants
INTERVENTIONAL
2013-03-29
2019-01-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open Label Study of Postmenopausal Women With Oestrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) With Exemestane, With Exploratory Epigenetic Marker Analysis
NCT01743560
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole
NCT00863655
Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
NCT01231659
Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer
NCT00032136
Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer
NCT00003418
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
everolimus
one 10 mg tablet or two 5 mg tablets of everolimus were administered orally once daily on a continuous dosing schedule starting on Day 1
exemestane
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
everolimus
one 10 mg tablet or two 5 mg tablets of everolimus were administered orally once daily on a continuous dosing schedule starting on Day 1
exemestane
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
* Disease refractory to non-steroidal aromatase inhibitors, defined as:
* Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or
* Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
* Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.
* Patients must have had:
* At least one lesion that could have been accurately measured in at least one dimension
* 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or
* Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
* Adequate bone marrow, coagulation, liver and renal function.
* ECOG performance status ≤ 2.
Exclusion Criteria
* Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites).
* Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days.
* Previous treatment with mTOR inhibitors.
* Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
* Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required.
* Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
* History of brain or other CNS metastases, including leptomeningeal metastasis.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Garran, Australian Capital Territory, Australia
Novartis Investigative Site
Caringbah, New South Wales, Australia
Novartis Investigative Site
Liverpool, New South Wales, Australia
Novartis Investigative Site
Box Hill, Victoria, Australia
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Ringwood East, Victoria, Australia
Novartis Investigative Site
St Albans, Victoria, Australia
Novartis Investigative Site
Karamsad, Gujarat, India
Novartis Investigative Site
Nashik, Maharashtra, India
Novartis Investigative Site
Pune, Maharashtra, India
Novartis Investigative Site
Cuttack, Odisha, India
Novartis Investigative Site
Bandung, , Indonesia
Novartis Investigative Site
Jakarta, , Indonesia
Novartis Investigative Site
Semarang, , Indonesia
Novartis Investigative Site
Yogyakarta, , Indonesia
Novartis Investigative Site
Amman, , Jordan
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Novartis Investigative Site
Kuala Lumpur, MYS, Malaysia
Novartis Investigative Site
Kota Kinabalu, Sabah, Malaysia
Novartis Investigative Site
Casablanca, , Morocco
Novartis Investigative Site
Rabat, , Morocco
Novartis Investigative Site
Cape Town, Western Cape, South Africa
Novartis Investigative Site
George, Western Cape, South Africa
Novartis Investigative Site
Western Cape, Western Cape, South Africa
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Novartis Investigative Site
Jeollanam-do, Jeollanam-do, South Korea
Novartis Investigative Site
Gyeonggi-do, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Seocho Gu, South Korea
Novartis Investigative Site
Busan, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Taegu, , South Korea
Novartis Investigative Site
Kaoshiung, Taiwan, Taiwan
Novartis Investigative Site
New Taipei City, TWN, Taiwan
Novartis Investigative Site
Changhua, , Taiwan
Novartis Investigative Site
Kaohsiung City, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Chiang Mai, , Thailand
Novartis Investigative Site
Aryanah, , Tunisia
Novartis Investigative Site
Pendik / Istanbul, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Gaziantep, , Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Kartal, , Turkey (Türkiye)
Novartis Investigative Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRAD001JIC06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.