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Spots Global Cancer Trial Database for Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

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Trial Identification

Brief Title: Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Official Title: A Phase IIIb, Multi-center, Open-label Study of RAD001 in Combination With EXemestane in Post-menopausal Women With EStrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer

Study ID: NCT03176238

Study Description

Brief Summary: This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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, Orissa, India

Novartis Investigative Site, Bandung, , Indonesia

Novartis Investigative Site, Jakarta, , Indonesia

Novartis Investigative Site, Jogyakarta, , Indonesia

Novartis Investigative Site, Semarang, , Indonesia

Novartis Investigative Site, Amman, , Jordan

Novartis Investigative Site, Suwon, Gyeonggi-do, Korea, Republic of

Novartis Investigative Site, Gyeonggi do, Korea, Korea, Republic of

Novartis Investigative Site, Seoul, Korea, Korea, Republic of

Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of

Novartis Investigative Site, Busan, , Korea, Republic of

Novartis Investigative Site, Jeollanam-do, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Taegu, , Korea, Republic of

Novartis Investigative Site, Kuala Lumpur, MYS, Malaysia

Novartis Investigative Site, Kota Kinabalu, Sabah, Malaysia

Novartis Investigative Site, Kuala Lumpur, Wilayah Persekutuan, 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, , South Africa

Novartis Investigative Site, New Taipei City, TWN, Taiwan

Novartis Investigative Site, Changhua, , Taiwan

Novartis Investigative Site, Kaohsiung City, , Taiwan

Novartis Investigative Site, Kaoshiung, , 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, Ariana, , Tunisia

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Gaziantep, , Turkey

Novartis Investigative Site, Izmir, , Turkey

Novartis Investigative Site, Kartal, , Turkey

Novartis Investigative Site, Pendik / Istanbul, , Turkey

Novartis Investigative Site, Ho Chi Minh, , Vietnam

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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