Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid
A Pilot Study of the Impact of a Single Dose of Zoledronic Acid on Biomarkers in Breast Cancer
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. To evaluate 14 tumor biomarkers of growth and metastasis (10 by microarray and 4 by RT-PCR) for change in response to ZA.
SECONDARY OBJECTIVES:
I. To evaluate 30 measures of immunologic function (by Luminex panel) for change in response to ZA a) after 48-72 hours and b) after 10-23 days.
II. To explore additional tumors biomarkers (approximately 20 by immunohistochemistry) for change in response to ZA.
OUTLINE: Patients receive zoledronic acid intravenously (IV) over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis.
After completion of study treatment, patients are followed up at 40-44 days.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Postmenopausal women
- Diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy)
- Estrogen receptor (ER)/progesterone receptor (PR) positive tumor (as confirmed by City of Hope Pathology Department if done on the outside) or
- Biopsy proven ER/PR positive tumor
- Ability to provide informed consent
Exclusion Criteria:
- Tumor that lacks both estrogen and progesterone receptors
- Patients who will receive neoadjuvant therapy prior to definitive surgery
- Bisphosphonate therapy currently or within the past 12 months
- Regular use of anti-inflammatory agents, with the exception of a baby aspirin regimen per principal investigator's (PI's) discretion
- Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the Cockcroft-Gault formula using the patient's actual weight
- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
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: Treatment (zoledronic acid)
Patients receive a single dose of zoledronic acid 4 mg IV over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis. zoledronic acid: Given IV laboratory biomarker analysis: Correlative studies therapeutic conventional surgery: Undergo definitive lumpectomy or mastectomy |
상관 연구
주어진 IV
다른 이름들:
Undergo definitive lumpectomy or mastectomy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean (SE) Change From Pre-Treatment Baseline in (Log)pg/mL of Biomarker, by Time, Adjusted for Level at Baseline
기간: "48-72 hrs" and "Surgery (10-23 days)"
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After the trial's premature closure, no data were collected for the primary endpoints; however, data on 14 of 30 secondary endpoints were obtained and are summarized below.
Serum level (pg/mL) per biomarker was log-transformed.
Change from baseline over time was evaluated using a generalized linear mixed model where follow-up time was represented by terms for the sequence of post-baseline samples or for (log)day on study.
To recognize regression to the mean across repeated samples, a term for biomarker level at baseline, with or without interaction by time, was included when it improved the model's fit to the observed data.
With 14 biomarkers sampled twice after baseline, there were 28 evaluations of change in biomarker level with exposure to study drug.
Therefore, to control the False Discovery Rate (FDR), only evaluations that maintained the study's FDR at no more than 5 percent were accepted as true.
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"48-72 hrs" and "Surgery (10-23 days)"
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- 10192 (레지스트리 식별자: DAIDS ES)
- NCI-2011-02137 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
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