- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00821886
Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer
2014년 12월 12일 업데이트: SCRI Development Innovations, LLC
Phase II Study of Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer
In this phase II trial the investigators propose to evaluate ixabepilone in combination with carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer patients.
Patients with early stage, HER2-positive breast cancer will receive six cycles of neoadjuvant treatment with ixabepilone, carboplatin, and trastuzumab every three weeks prior to surgery; after surgery, patients will continue treatment with trastuzumab every three weeks until week 52.
Concomitant with the post-operative trastuzumab treatment, patients with hormone receptor-positive tumors will receive anti-estrogen treatment.
Also, after the completion of chemotherapy, patients may receive radiation treatment at the discretion of their physician.
연구 개요
연구 유형
중재적
등록 (실제)
60
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Fort Myers, Florida, 미국, 33901
- Florida Cancer Specialists
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Georgia
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Augusta, Georgia, 미국, 30901
- Medical Oncology Associates of Augusta
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Indiana
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Terre Haute, Indiana, 미국, 47802
- Providence Medical Group
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Maine
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Portland, Maine, 미국, 04101
- Mercy Hospital
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Maryland
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Bethesda, Maryland, 미국, 20817
- Center for Cancer and Blood Disorders
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Bethesda, Maryland, 미국, 20817
- National Capital Clinical Research Consortium
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Michigan
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Grand Rapids, Michigan, 미국, 49503
- Grand Rapids Clinical Oncology Program
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Missouri
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Chesterfield, Missouri, 미국, 63017
- St. Louis Cancer Care
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New Jersey
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Morristown, New Jersey, 미국, 07960
- Hematology Oncology Associates of Northern NJ
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Ohio
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Cincinnati, Ohio, 미국, 45242
- Oncology Hematology Care
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Tennessee
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Nashville, Tennessee, 미국, 37023
- Tennessee Oncology, PLLC
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Virginia
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Richmond, Virginia, 미국, 23235
- Virginia Cancer Institute
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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
모두
설명
Inclusion Criteria:
- Female and male patients ≥18 years of age.
- Histologically confirmed adenocarcinoma of the breast.
- Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-T3, N1-N2, M0). (T1N0M0 lesions are excluded.)
- Patients who have no clearly defined palpable breast mass or axillary lymph nodes but are radiographically measurable are eligible. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. In these patients, radiographic tumor measurements need to be repeated after 3 cycles and prior to surgery.
- Positive HER2 status (overexpression and/or amplification of HER2 in the primary tumor) as defined by: IHC 3+ or fluorescence in situ hybridization (FISH) positive (ratio >2.2) testing. Documentation of the HER2 results must be available at the time of study enrollment.
- An ECOG (Eastern Cooperative Oncology Group) performance score of ≤2
Normal bone marrow function as defined by:
- absolute neutrophil count (ANC) >1,500/µL;
- platelets >100,000/µL;
- hemoglobin >10 g/dL.
- Normal hepatic and renal function.
- Left ventricular ejection fraction (LVEF) within the institutional limits of normal, whichever is lower, as measured by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO).
- Life expectancy > 12 weeks.
- Estrogen and progesterone (or estrogen alone) receptor status in the primary tumor known or pending at the time of study enrollment.
- For women of childbearing potential, negative serum pregnancy test within 7 days prior to starting treatment.
- For women of childbearing potential, agreement to use a method of contraception that is acceptable to their physician from time of first signing the informed consent until at least 3 months after the last dose of study drug. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. Patient agreement to discontinue breast-feeding, if applicable, during study treatment. Men enrolled in the study must also agree to use a method of contraception that is acceptable to their physician during their study participation.
- For patients with previous invasive cancers (including breast cancer) treated with curative intent, completion of chemotherapy or radiation therapy more than 5 years prior to enrollment for this study and no evidence of recurrent disease. Patients may be receiving anti-estrogen hormonal therapy prescribed for previous invasive breast cancer as long as the diagnosis of invasive cancer was made more than 5 years prior to study enrollment. Patients may be using anti-estrogen hormonal therapy at the time of current diagnosis but must discontinue this therapy before beginning study treatment.
- For patients who had, or will have sentinel lymph node and/or axillary dissection prior to initiation of study treatment, completion at least 4 weeks prior to starting study treatment and well-healed wound.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Previous treatment for this breast cancer.
- Evidence of metastatic disease.
- Prior radiation that included ≥30% of major bone marrow-containing areas.
- Women who are pregnant or breastfeeding.
- Neuropathy (motor or sensory) ≥grade 1 at study entry.
History of significant cardiac disease or cardiac risk factors or the following:
- uncontrolled arrhythmias
- poorly controlled hypertension (e.g., systolic blood pressure [BP]> 150 mmHg or diastolic BP >100 mmHg) in spite of optimal medical management
- angina pectoris requiring antianginal medication or unstable angina within the previous 6 months
- history of documented congestive heart failure (CHF)
- any documented myocardial infarction within the previous 6 months
- clinically significant valvular heart disease
- current use of medications (e.g., digitalis, beta-blockers, calcium channel-blockers) that alter cardiac conduction, if these medications are administered for the management of cardiac arrhythmia, angina, or CHF. If these medications are administered for other reasons (e.g., hypertension), the patient may be eligible.
- patients with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG unless ECHO or MUGA scan within the last 3 months demonstrates that the LVEF is ≥ institutional lower limit of normal.
- Symptomatic intrinsic lung disease.
- Active malignancy, other than superficial basal cell carcinoma, superficial squamous (skin) cell carcinoma, carcinoma in situ, or non-invasive breast cancer, within the past 5 years.
- Uncontrolled intercurrent illness including (but not limited to) ongoing or active infection >grade 2.
- Mental condition or psychiatric disorder rendering the subject unable to understand the nature, scope, and possible consequences of the study or that would limit compliance with study requirements.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving a reasonable suspicion of a disease or condition that contraindicates the use of a study agent or that may affect the interpretation of the results or renders the subjects at high risk from treatment complications.
- Chronic use of CYP3A4 inhibitors and use of the following strong CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, and voriconazole. Use of these agents must be discontinued at least 72 hours prior to initiation of study treatment.
- Received chemotherapy for any indication within the 5 years preceding study enrollment.
- Prior treatment with trastuzumab or any other anti-HER2 agent for any indication.
- Concurrent treatment with any other anti-cancer therapy.
- Concurrent radiation therapy during neoadjuvant study treatment.
- Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to study enrollment.
- Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention of breast cancer. These agents must be discontinued prior to study enrollment.
- Participation within the previous 30 days in a study with an experimental drug.
- Known or suspected allergy to Cremophor EL (polyoxyethylated castor oil), a drug formulated in Cremophor EL such as paclitaxel, or any other agent given in the course of this trial.
- Inability or unwillingness to comply with study procedures including those for follow-up.
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: Ixabepilone/Trastuzumab/Carboplatin
Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
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Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
다른 이름들:
Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period.
Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
다른 이름들:
Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pathologic Complete Response (pCR)
기간: average18 months
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Proportion of patients who do not exhibit residual invasive breast cancer in breast or axillary lymph nodes at time of surgery
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average18 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects With Adverse Events as a Measure of Safety and Toxicity
기간: Day 1 of each 3 week cycle up to 6 cycles , and every 9 weeks post-surgery until treatment discontinuation
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Assessment based on the frequency of treatment-related adverse events according to NCI CTCAE criteria v3.0.
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Day 1 of each 3 week cycle up to 6 cycles , and every 9 weeks post-surgery until treatment discontinuation
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Disease-free Survival
기간: expected average 18 months
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Defined as the interval from the first date of study treatment until the date of tumor recurrence or death from any cause
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expected average 18 months
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Overall Survival
기간: approximately 48 months
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Defined as the time between Day 1 Cycle 1 to date of death from any cause.
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approximately 48 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Denise Yardley, M.D., SCRI Development Innovations, LLC
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
2009년 2월 1일
기본 완료 (실제)
2011년 7월 1일
연구 완료 (실제)
2014년 10월 1일
연구 등록 날짜
최초 제출
2009년 1월 12일
QC 기준을 충족하는 최초 제출
2009년 1월 12일
처음 게시됨 (추정)
2009년 1월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 12월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 12월 12일
마지막으로 확인됨
2014년 12월 1일
추가 정보
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. .
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