Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer (PALINA)
2021년 9월 7일 업데이트: Georgetown University
Phase II Safety Study of Palbociclib in Combination With Letrozole or Fulvestrant in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer.
Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuation due to neutropenia according to current recommendations for management of neutropenia
연구 개요
상세 설명
The study is designed to assess the rate of completion of planned oncology therapy in the absence of a hematological event defined as episodes of febrile neutropenia and treatment discontinuation due to neutropenia. A completion rate of 80% is considered of clinical relevance as to benefit breast cancer patients who are at a higher risk of having ethnic neutropenia where as a completion rate of 60% is considered poor and to justify additional safety studies. A two stage design with a total of 35 patients is used to test if the completion rate is at least 80% versus if it is below 60% with 80% power at a significance level of 5%.
An exact confidence interval of the completion rate will be calculated. Investigators estimate there will be no more than a 10% rate of febrile neutropenia. Due to the small sample size, the analysis of secondary endpoints will be descriptive and will not include specific hypothesis testing.
연구 유형
중재적
등록 (실제)
35
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20007
- MedStar Georgetown University Hospital
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Washington, District of Columbia, 미국, 20013
- MedStar Washington Hospital Center
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago
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Maryland
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Baltimore, Maryland, 미국, 21218
- MedStar Union Memorial Hospital
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Baltimore, Maryland, 미국, 21239
- MedStar Good Samaritan Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Thomas Jefferson University
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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:
- Self-identified Black, African or African American women of ≥ 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
- ER-positive and/or PgR-positive tumor based on local laboratory results
- HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)
- Patients must be appropriate candidates for letrozole or fulvestrant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate bone marrow function:
- Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 (1.0 x 109/L);
- Platelets ≥100,000/mm3 (100 x 109/L);
- Hemoglobin ≥9 g/dL (90 g/L).
Exclusion Criteria:
- Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
- Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.
Previous CDK4/6 inhibitor
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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 |
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실험적: Palbociclib + Letrozole or Fulvestrant
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Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event
기간: 12 months
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For study purpose febrile neutropenia will be defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: "ANC less than 1000/mm3 with a single temperature of >38.3 degrees Celsius (101 degrees Fahrenheit) or a sustained temperature of 38 degrees Celsius (100.4 degrees Fahrenheit) for more than one hour." Planned oncology therapy is defined as completion of one year of therapy for advanced breast cancer in the absence of disease progression or cessation of study drug due to progressive disease or non-hematological toxicity. |
12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Dose Delays in Palbociclib Attributed to Neutropenia
기간: 12 months
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Number of patients who required dose delays in palbociclib attributed to neutropenia.
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12 months
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Dose Reductions in Palbociclib Therapy Attributed to Neutropenia
기간: 12 months
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Number of patients who required dose reductions in palbociclib therapy
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12 months
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Clinical Benefit Rate
기간: 24 weeks
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Clinical Benefit Rate (CBR), for those with evaluable disease, defined as the percentage of patients who achieved complete response, partial response and stable disease.
RECIST 1.1 was used as the standard way to measure response to treatment.
The mean (SD) of specific metabolites were calculated at each time point and graphically assess these measures over time with clinical response and hematological toxicity.
The mean change in these variables from baseline to each follow-up point was be calculated.
Generalized linear model was utilized for the correlative analysis of clinical response and hematologic events.
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24 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Claudine Isaacs, MD, MedStar Georgetown University Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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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)
2016년 9월 1일
기본 완료 (실제)
2019년 12월 16일
연구 완료 (실제)
2021년 3월 23일
연구 등록 날짜
최초 제출
2016년 2월 23일
QC 기준을 충족하는 최초 제출
2016년 2월 25일
처음 게시됨 (추정)
2016년 2월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 7일
마지막으로 확인됨
2021년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2015-1396
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .