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Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (EVEREXES)

2020년 4월 6일 업데이트: Novartis Pharmaceuticals

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

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

235

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 남아프리카
      • Western Cape, 남아프리카, 7925
        • Novartis Investigative Site
    • Western Cape
      • Cape Town, Western Cape, 남아프리카, 7925
        • Novartis Investigative Site
      • George, Western Cape, 남아프리카, 6530
        • Novartis Investigative Site
  • 대만
      • Changhua, 대만, 50006
        • Novartis Investigative Site
      • Kaohsiung City, 대만, 83301
        • Novartis Investigative Site
      • Kaoshiung, 대만, 80756
        • Novartis Investigative Site
      • Taipei, 대만, 10048
        • Novartis Investigative Site
      • Taipei, 대만, 10449
        • Novartis Investigative Site
    • TWN
      • New Taipei City, TWN, 대만, 23561
        • Novartis Investigative Site
  • 대한민국
      • Busan, 대한민국, 602739
        • Novartis Investigative Site
      • Jeollanam-do, 대한민국, 519763
        • Novartis Investigative Site
      • Seoul, 대한민국, 03080
        • Novartis Investigative Site
      • Seoul, 대한민국, 06351
        • Novartis Investigative Site
      • Seoul, 대한민국, 03722
        • Novartis Investigative Site
      • Seoul, 대한민국, 02841
        • Novartis Investigative Site
      • Seoul, 대한민국, 06273
        • Novartis Investigative Site
      • Seoul, 대한민국, 01812
        • Novartis Investigative Site
      • Taegu, 대한민국, 41944
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, 대한민국, 443380
        • Novartis Investigative Site
    • Korea
      • Gyeonggi do, Korea, 대한민국, 10408
        • Novartis Investigative Site
      • Seoul, Korea, 대한민국, 05505
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul, Seocho Gu, 대한민국, 06591
        • Novartis Investigative Site
  • 말레이시아
    • MYS
      • Kuala Lumpur, MYS, 말레이시아, 56000
        • Novartis Investigative Site
    • Sabah
      • Kota Kinabalu, Sabah, 말레이시아, 88586
        • Novartis Investigative Site
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, 말레이시아, 50586
        • Novartis Investigative Site
  • 모로코
      • Casablanca, 모로코
        • Novartis Investigative Site
      • Rabat, 모로코, 6527
        • Novartis Investigative Site
  • 베트남
      • Ho Chi Minh, 베트남, 700000
        • Novartis Investigative Site
  • 요르단
      • Amman, 요르단, 11941
        • Novartis Investigative Site
  • 인도
    • Gujarat
      • Karamsad, Gujarat, 인도, 388325
        • Novartis Investigative Site
    • Maharashtra
      • Nashik, Maharashtra, 인도, 422 004
        • Novartis Investigative Site
      • Pune, Maharashtra, 인도, 411013
        • Novartis Investigative Site
    • Orissa
      • Cuttack, Orissa, 인도, 753 007
        • Novartis Investigative Site
  • 인도네시아
      • Bandung, 인도네시아, 40161
        • Novartis Investigative Site
      • Jakarta, 인도네시아, 11420
        • Novartis Investigative Site
      • Jogyakarta, 인도네시아, 55284
        • Novartis Investigative Site
      • Semarang, 인도네시아, 50212
        • Novartis Investigative Site
  • 칠면조
      • Ankara, 칠면조, 06100
        • Novartis Investigative Site
      • Ankara, 칠면조, 06500
        • Novartis Investigative Site
      • Ankara, 칠면조, 06460
        • Novartis Investigative Site
      • Gaziantep, 칠면조, 27310
        • Novartis Investigative Site
      • Izmir, 칠면조, 35040
        • Novartis Investigative Site
      • Kartal, 칠면조, 34890
        • Novartis Investigative Site
      • Pendik / Istanbul, 칠면조, 34899
        • Novartis Investigative Site
  • 태국
      • Bangkok, 태국, 10400
        • Novartis Investigative Site
      • Bangkok, 태국, 10300
        • Novartis Investigative Site
      • Chiang Mai, 태국, 50200
        • Novartis Investigative Site
  • 튀니지
      • Ariana, 튀니지, 2080
        • Novartis Investigative Site
  • 호주
    • Australian Capital Territory
      • Garran, Australian Capital Territory, 호주, 2605
        • Novartis Investigative Site
    • New South Wales
      • Caringbah, New South Wales, 호주, 2229
        • Novartis Investigative Site
      • Liverpool, New South Wales, 호주, 2170
        • Novartis Investigative Site
    • Victoria
      • Box Hill, Victoria, 호주, 3128
        • Novartis Investigative Site
      • Heidelberg, Victoria, 호주, 3084
        • Novartis Investigative Site
      • Ringwood East, Victoria, 호주, 3135
        • Novartis Investigative Site
      • St Albans, Victoria, 호주, 3021
        • Novartis Investigative Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
  • 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 overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test.
  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
의약품: 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
다른 이름들:
  • RAD001
의약품: exemestane
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
기간: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period
Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Response Rates (Best Overall and Overall)
기간: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
The best overall response for each patient is determined from the sequence of investigator overall lesion responses according to RECIST 1.1: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. To be assigned a best overall response of CR at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best overall response of PR at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Percentage of Participants Clinical Benefit Rate
기간: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Clinical benefit rate: Patients with best overall response rate of CR (any duration), PR (any duration) and SD with duration of 24 weeks or longer according to RECIST 1.1 criteria: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. Best overall response of CR = at least two determinations of CR at least 4 weeks apart before progression are required. Best overall response of PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method.
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Progression Free Survival (PFS)
기간: Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries

PFS is time from date of start of treatment to date of disease progression or death due to any cause, whichever occurs first.

b Percentiles with 95% CIs are calculated from PROC LIFETEST output using method of Brookmeyer and Crowley (1982)
Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries
Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
기간: Baseline up to approximately 50 weeks
Time to deterioration of ECOG performance status, from baseline will be assessed using the ECOG Performance Status Scale (Oken, 1982). Time to deterioration is the time from date of start of treatment to the date of the event defined as deterioration. Deterioration is defined as an increase in performance status from 0 to 2 or greater, an increase in performance status from 1-2 to 3 or greater, or death due to any cause. Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Event-free probability estimates were are obtained from the Kaplan-Meier survival estimates.
Baseline up to approximately 50 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2013년 3월 29일

기본 완료 (실제)

2019년 1월 29일

연구 완료 (실제)

2019년 1월 29일

연구 등록 날짜

최초 제출

2017년 6월 1일

QC 기준을 충족하는 최초 제출

2017년 6월 1일

처음 게시됨 (실제)

2017년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 4월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 4월 6일

마지막으로 확인됨

2020년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CRAD001JIC06

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

everolimus에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Finland

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다