- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03329937
Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer
An Open-Label, Single-arm Pilot Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Localized, HER2-negative, BRCA-mutant Breast Cancer Patients
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Fort Myers, Florida, 미국, 33908
- GSK Investigational Site
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Tampa, Florida, 미국, 33612
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, 미국, 21231
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- GSK Investigational Site
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Minnesota
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Rochester, Minnesota, 미국, 55905
- GSK Investigational Site
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New York
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New York, New York, 미국, 10029
- GSK Investigational Site
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Tennessee
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Nashville, Tennessee, 미국, 37203
- GSK Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants age >= 18 years old.
- Participants with a deleterious or suspected deleterious breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutation (germline or somatic) may be enrolled into the study based on either local or central laboratory testing of BRCA status.
- Histologically-confirmed HER2-negative localized breast cancer by core biopsy.
- Primary operable, non-metastatic invasive carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is not allowed. In participants with multifocal and/or multicentric, the largest lesion should be measured. Both unilateral and bilateral breast cancer are allowed.
- Primary tumor size >=1cm.
- Measurable disease by breast ultrasound and MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function defined as:
- Absolute neutrophil count (ANC) >=1500 per microliters (/μL).
- Platelets >=100,000/μL.
- Hemoglobin >=9 grams per deciliter (g/dL).
- Serum creatinine <=1.5*upper limit of normal (ULN) or calculated creatinine clearance >=50 milliliters per minute (mL/min) using Cockcroft-Gault equation.
- Total bilirubin <=1.5*ULN except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin <=1.5*ULN of the direct bilirubin.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5*ULN.
- Participants must have recovered to Grade 1 toxicity from prior cancer therapy (a participant with Grade 2 neuropathy or Grade 2 alopecia is an exception to this criterion and may qualify for this study).
- Participant able to take oral medications.
Participant meets the following criteria:
- Female participant (of childbearing potential) is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug, or is of non-childbearing potential.
- Female participant is of non-childbearing potential (other than medical reasons) as defined:
i) >=45 years of age and has not had menses for >1 year. ii) Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon the screening evaluation.
iii) Has undergone post hysterectomy, bilateral oophorectomy, or tubal ligation. Documented hysterectomy, oophorectomy or tubal ligation must be confirmed in the medical records, otherwise the participant must be willing to use 2 adequate barrier methods throughout the study starting from the screening visit through 180 days after the last dose of study drug. Information must be captured appropriately within the site's source documents.
c) Male participant agrees to use an effective method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- Able to understand the study procedures and agree to participate in the study by providing written informed consent.
Exclusion Criteria:
- Prior anti-cancer therapies for current malignancy.
- Known evidence of distant metastasis. Staging studies are not required. The decision to pursue staging studies is at the discretion of the treating clinician, based on the participant's clinical and pathological findings consistent with standard guidelines.
- Known hypersensitivity to the components of niraparib components or their formulation excipients.
- Major surgery within 3 weeks of starting the study or participant has not recovered from any effects of any major surgery.
- Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, uncontrolled hypertension, active uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits obtaining informed consent.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study drug, or is not in the best interest of the participant to participate.
- Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study drug or within the 180-day period after the last dose of study drug.
- Immunocompromised participants.
- Known active hepatic disease (Hepatitis B or C).
- Prior treatment with a known PARP inhibitor.
- Other active malignancy that warrants systemic therapy.
- Known history of myelodysplastic syndromes (MDS) or Acute myeloid leukemia (AML).
공부 계획
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: Participants with HER2-negative and BRCAmut breast cancer
Participants with HER2-negative and BRCAmut localized breast cancer (primary tumor >=1 cm) will receive niraparib (200 mg PO).
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Niraparib is a potent, orally active, highly selective poly adenosine diphosphate ([ADP]-ribose) polymerase 1 (PARP1) and PARP2 inhibitor.
It will be supplied as 100 mg capsules and will be administered at starting dose of 200 mg PO daily throughout 28 days for 2 cycles (each cycle is 28 days), with the potential for an additional 4 cycles (maximum total of 6 cycles) at the assigned dose and schedule.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Tumor Response Measured by Breast MRI
기간: At 2 months
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Tumor response measured by breast MRI is defined as >=30 percent (%) reduction of tumor volume from Baseline based on primary lesion after niraparib treatment without any new lesion development.
Tumor volume was calculated as (length × width × height × pi [π])/6.
Responses were assessed as Clinical complete response (CR): A complete disappearance of all tumor signs in the breast as assessed by imaging test.
Clinical partial response (PR): A reduction in the tumor volume of the primary tumor size by >=30% assessed by palpation or imaging test.
Clinical stable disease (SD): No significant change in tumor volume during treatment.
Clinical progressive disease (cPD): The development of new, previously undetected lesions, or an estimated increase in the size of the primary lesion by greater than 20%.
Percentage of participants with tumor response and its 95 percent confidence interval (CI) has been presented.
The 95% CI was the binomial exact CI based on Clopper-Pearson method.
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At 2 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Pathological Complete Response (pCR)
기간: Up to 1 year
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pCR is defined as ypT0/Tis ypN0 by receipt of pre-operative chemotherapy (Yes versus No).
Following neoadjuvant therapy, pathological staging is recorded using the 'yp' designation.
ypT0/Tis ypN0 is the absence of invasive cancer in the breast and axillary nodes.
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current American Joint Committee on Cancer [AJCC] staging system).
Percentage of participants with pCR rate its 95 percent CI has been presented.
CI was based on binomial exact CI.
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Up to 1 year
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Percentage of Participants With Tumor Response as Measured by Breast Ultrasound
기간: Up to 6 months
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Tumor response rate was based on the change in tumor volume as measured by breast ultrasound; a response was considered >=30 percent reduction of tumor volume from Baseline without any new lesion development.
Tumor volume was calculated as (length × width × height × π)/6.
Percentage of participants with tumor response and its 95 percent CI has been presented.
CI was based on binomial exact CI.
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Up to 6 months
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Percent Change From Baseline in Tumor Volume Measured by Ultrasound
기간: Baseline and up to 6 months
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Percentage change in tumor volume from Baseline was measured using ultrasound.
Baseline was defined as the most recent measurement prior to the first administration of niraparib.
Tumor volume was calculated as (length × width × height × π)/6.
The percentage reduction in tumor volume was set as 99% if the tumor becomes too small to measure at the post-baseline visit.
Percent change from Baseline was defined as greatest change in volume, derived from all available cycles of niraparib (range from cycle 2 to 6) and multiplied by 100.
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Baseline and up to 6 months
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Percent Change From Baseline in Tumor Volume Measured by MRI
기간: Baseline and at 2 months
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Percentage change in tumor volume from Baseline after 2 months of niraparib treatment was measured using MRI.
Baseline was defined as the most recent measurement prior to the first administration of niraparib.
Tumor volume was calculated as (length × width × height × π)/6.
The percentage reduction in tumor volume was set as 99% if the tumor becomes too small to measure at the post-baseline visit.
Percent change from Baseline was defined as value of post Baseline minus Baseline value and multiplied by 100.
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Baseline and at 2 months
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Discontinuations and Dose Reductions Due to Adverse Events (AEs)
기간: Up to 1 year
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or an important medical event.
A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
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Up to 1 year
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 213355
- 3000-01-005 (기타 식별자: Tesaro)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
신생물, 유방에 대한 임상 시험
Niraparib에 대한 임상 시험
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Sir Mortimer B. Davis - Jewish General Hospital아직 모집하지 않음자궁내막암 | 자궁 신생물 | 장액 선암종
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Institut Paoli-CalmettesGlaxoSmithKline아직 모집하지 않음
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Tesaro, Inc.European Network of Gynaecological Oncological Trial Groups (ENGOT); US Oncology Research; Sarah Cannon 그리고 다른 협력자들완전한난소 신생물 | 백금 민감성 난소암미국, 벨기에, 스웨덴, 독일, 이스라엘, 오스트리아, 캐나다, 덴마크, 스페인, 이탈리아, 영국, 폴란드, 프랑스, 헝가리, 노르웨이
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University Hospital Southampton NHS Foundation...British Lung Foundation; University of Southampton모집하지 않고 적극적으로
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Institute of Cancer Research, United KingdomRoyal Marsden NHS Foundation Trust아직 모집하지 않음
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Sun Yat-sen University모병
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Tesaro, Inc.GOG Foundation; European Network of Gynaecological Oncological Trial Groups (ENGOT)모집하지 않고 적극적으로신생물미국, 캐나다, 네덜란드, 스페인, 핀란드, 벨기에, 독일, 이스라엘, 덴마크, 스웨덴, 영국, 폴란드, 헝가리, 노르웨이, 이탈리아, 그리스, 체코, 우크라이나, 벨라루스, 칠면조
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Janssen Research & Development, LLC모집하지 않고 적극적으로거세 저항성 전립선암미국, 중국, 이탈리아, 대한민국, 대만, 호주, 스웨덴, 벨기에, 캐나다, 프랑스, 헝가리, 이스라엘, 말레이시아, 러시아 연방, 포르투갈, 독일, 불가리아, 스페인, 네덜란드, 칠면조, 영국, 우크라이나, 폴란드, 아르헨티나, 브라질, 멕시코, 푸에르토 리코, 체코, 남아프리카