이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance (POWER PIINC)

2018년 7월 5일 업데이트: University of Utah
The purpose of the study is to see if tumors respond to endocrine therapy by taking a total of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Patients who are eligible (newly diagnosed hormone positive clinical stage 1 or 2 breast cancer) will be approached about the study. If they sign informed consent a prescription for 21 doses of Tamoxifen will be provided. The patient's surgery will be scheduled at a time convenient for the patient and the surgeon. Once the surgery has been scheduled, a medication calendar will be completed that allows the patient to take tamoxifen for 7 days preoperatively with the 7th dose of tamoxifen to coincide with the day before surgery. The patient will continue to take tamoxifen for 2 weeks (14 days) after surgery. Patients will then proceed along normal treatment guidelines. For those needing chemotherapy or radiation therapy, we recommend the long term endocrine therapy start at the conclusion of chemo and/or radiation treatments. For those not going on to any additional therapy, the prescription for endocrine therapy will be written at the initial post-operative visit.

Unstained slides from the formalin-fixed, paraffin-embedded tissue blocks from the patient's breast tissue from which the original diagnosis of breast cancer was made by H&E will be stained for Ki67. After endocrine therapy and subsequent resection, carcinoma will be confirmed by the participating pathologist on H&E, and Ki67 will be performed on unstained slides from a representative tissue block containing invasive carcinoma. The pathologist will circle a designated area of tumor on the H&E slide and both the H&E and immunostained (Ki67) slides will be scanned in a digital imaging device (Aperio XT Scanscope), which quantitatively analyzes the tumor designated by the pathologist with image analysis algorithms. The algorithm accurately detects regions of interest and distinguishes cells and sub-cellular objects within these target regions. It determines morphology and expression profiles per individual cell or cell compartment. For Ki67 analysis, a nuclear Immunohistochemistry (IHC) algorithm will be used.

연구 유형

중재적

등록 (실제)

52

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • Huntsman Cancer Institute

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:

  • Age > 18 years old
  • Diagnosed with hormone receptor positive invasive breast cancer (estrogen receptor (ER) or progesterone receptor (PR) or both >1%) by core needle biopsy
  • Clinical American Joint Committee on Cancer (AJCC) 7th edition Stage 1 or 2
  • Candidate for surgical therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2
  • No chemotherapy or endocrine therapy for breast cancer in last 5 years
  • Paraffin fixed core needle tissue block, or biopsy punch available for central analysis for proliferative markers
  • Not pregnant or lactating and practicing adequate birth control if premenopausal
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Prior personal history of uterine cancer
  • Prior personal history of stroke or deep vein thrombosis (DVT)
  • Current therapy with strong CYP2D6 inhibitors The following medications should not be administered with tamoxifen (21 day treatment period) and will need to be stopped for the designated period of time prior to starting the study tamoxifen.

No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years

Fluoxetine - should be discontinued 30 days prior to starting tamoxifen Paroxetine - should be discontinued 5 days prior to starting tamoxifen Sertraline - should be discontinued 5 days prior to starting tamoxifen Bupropion - should be discontinued 5 days prior to starting tamoxifen

  • Concurrent coumarin-type anticoagulation therapy
  • Any other contraindications to tamoxifen therapy

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: All patients
All patients enrolled in the study.
의약품: Tamoxifen
All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.
절차: Breast cancer surgery
Breast cancer surgery

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Ki67 Expression in Tumors
기간: 7 days
Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.
7 days

2차 결과 측정

결과 측정
측정값 설명
기간
Change in FACT-ES Symptom Scores
기간: 18 months
Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 18 months following breast surgery to assess quality of life. The difference in total score from baseline to 18 months was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life.
18 months
Number of Participants With Long Term Endocrine Therapy Adherence
기간: 18 months
For the patient population on this study, endocrine therapy was indicated for 5 years post-surgery according to the current standard of care recommendations for hormone positive breast cancer. Endocrine therapy was prescribed as standard of care as appropriate for each patient's situation. At 18 months post-surgery, patients were evaluated to determine if they were taking their endocrine therapy as prescribed.
18 months
Correlation Between Changes in Ki67 and Symptoms
기간: 7 days
Evaluate correlation between changes in Ki67 expression and symptom scores. Differences between changes in FACT-ES total score were correlated with changes in Ki67 expression using a the Spearman correlation method and results are expressed as the correlation coefficient.
7 days

기타 결과 측정

결과 측정
측정값 설명
기간
Change in FACT-ES Symptom Scores
기간: 7 days
Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 7 days following start of tamoxifen to assess quality of life while on tamoxifen. The difference in total score from baseline to 7 days was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life.
7 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Utah

수사관

  • 수석 연구원: Leigh Neumayer, MD, Huntsman Cancer Institute

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

2012년 8월 1일

기본 완료 (실제)

2016년 11월 1일

연구 완료 (실제)

2016년 11월 1일

연구 등록 날짜

최초 제출

2012년 6월 4일

QC 기준을 충족하는 최초 제출

2012년 6월 6일

처음 게시됨 (추정)

2012년 6월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 8월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 7월 5일

마지막으로 확인됨

2018년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HCI57098

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