Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.
2012년 8월 3일 업데이트: Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
A Phase II Trial of Letrozole Plus OSI-774 (Tarceva) in Post-menopausal Women With ER and/or PR-Positive Metastatic Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well giving letrozole together with erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally recurrent or metastatic breast cancer.
연구 개요
상태
종료됨
정황
상세 설명
OBJECTIVES:
Primary
- To determine the rate of clinical benefit (complete response [CR], partial response [PR], and stable disease [SD] in patients with hormone-dependent locally recurrent or metastatic breast cancer treated with letrozole in combination with erlotinib hydrochloride.
Secondary
- To determine the time to progression (TTP) in patients treated with this regimen.
- To evaluate the anti-tumor activity, as determined by CR and PR rates, of this regimen in these patients.
- To evaluate the safety of this regimen in these patients.
- To determine if tumors that are positive for epidermal growth factor receptor (EGFR) or Ser118 ER, or that overexpress human epidermal receptor (HER2) exhibit a longer TTP from the combination compared to tumors that do not express or overexpress these molecules.
OUTLINE: This is a multicenter study. Patients are stratified according to prior hormone therapy (hormone-therapy naive/first-line therapy vs prior hormonal therapy with either tamoxifen or an aromatase inhibitor in the adjuvant or metastatic setting/second-line therapy)
Patients receive oral letrozole and oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then yearly thereafter.
연구 유형
중재적
등록 (실제)
48
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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Georgia
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Macon, Georgia, 미국, 31201
- Central Georgia Hematology/Oncology Associates, P.C.
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Kentucky
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Hopkinsville, Kentucky, 미국, 42240
- Jennie Stuart Medical Center
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Paducah, Kentucky, 미국, 42002
- Purchase Cancer Group
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Tennessee
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Chattanooga, Tennessee, 미국, 37404
- Memorial Health Care System
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Germantown, Tennessee, 미국, 38138
- The Jones Clinic - Germantown
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Jackson, Tennessee, 미국, 38301
- Jackson-Madison County Hospital
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Knoxville, Tennessee, 미국, 37909
- Tennessee Cancer Specialists
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Nashville, Tennessee, 미국, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, 미국, 37067
- Vanderbilt-Ingram Cancer Center - Cool Springs
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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
- Patients must have estrogen (ER) and/or progesterone receptor (PgR)-positive, histologically confirmed adenocarcinoma of the breast with measurable (but not operable) locally recurrent disease, or measurable and/or evaluable metastatic disease (see protocol section 10.3), including isolated bone metastases.
- Patients with available paraffin tissue blocks from either the primary or the metastatic site must submit tissue blocks for retrospective EGFR and HER2 analysis. If tissue blocks cannot be submitted, 20 unstained slides from each paraffin block must be submitted.
All patients must be post-menopausal females as defined by one of the following:
- Prior bilateral oophorectomy
- Prior bilateral ovarian irradiation
- No menstrual period for 12 months or longer
- If age 55 years or less and < 12 months from last menstrual period, patient must have a serum estradiol < or equal to 30 and an FSH level > 40.
- Patients must not have had more than 1 prior chemotherapy regimen for metastatic disease and have fully recovered from any grade 2-4 toxicities related to chemotherapy. No concurrent chemotherapy is allowed while on protocol therapy.
- Patients may have had 1 prior hormonal therapy for metastatic disease. This includes: tamoxifen, fulvestrant, anastrozole, exemestane, aminoglutethimide, megace, and letrozole. Patients may have received tamoxifen or aromatase inhibitors in the adjuvant setting.
- Patients must not have had prior therapy with EGF receptor inhibitors.
- Previous but not concomitant therapy with trastuzumab (Herceptin) is allowed. Patients must not have received Herceptin within 4 weeks of initiation of protocol therapy.
- Patients must have an ECOG performance status of 0, 1, or 2.
Patients must have adequate hematologic, hepatic, and renal function as defined by the following within 2 weeks of initiation of therapy:
- Absolute neutrophils > or equal to 1,500/mm3 and platelets > or equal to 100,000/mm3.
- Bilirubin < than or equal to 1.5 upper limit of normal.
- SGOT and SGPT < or equal to 2.5 upper limit of normal.
- Creatinine < or equal to 1.5 upper limit of normal.
- INR, PTT and PT in the normal range.
- Must be 18 years of age or older.
- Patients must not have a history of central nervous system metastases or unevaluated CNS symptoms suggestive of possible brain metastases.
- Patients may receive concurrent radiation therapy to painful bone metastases or areas of impending bone fracture as long as radiation therapy is initiated prior to study entry and sites of evaluable disease outside the radiation port(s) are available for follow-up. Patients who have received prior radiotherapy must have recovered from toxicity induced by this treatment.
- Patients < 55 years of age must not have received Luteinizing hormone releasing hormone (LHRH) antagonists within 3 months prior to protocol therapy.
- Patients must not suffer from medical or psychiatric conditions that would interfere with ability to provide informed consent, communicate side effects, or comply with protocol requirements including maintenance of a compliance/pill diary.
- Patients must be disease-free of prior invasive cancers for > 5 years with the exception of basal or squamous cancer of the skin or cervical carcinoma in situ.
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: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: First line/hormone-therapy naive
|
OSI-774 150 mg/day
다른 이름들:
Letrozole 2.5 mg/day
다른 이름들:
To determine HER2 gene amplification or excess copies of the HER2 gene
다른 이름들:
to measure the epidermal growth factor receptors (EGFR)
다른 이름들:
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
다른 이름들:
|
|
실험적: Second-line/prev hormone-therapy tx
|
OSI-774 150 mg/day
다른 이름들:
Letrozole 2.5 mg/day
다른 이름들:
To determine HER2 gene amplification or excess copies of the HER2 gene
다른 이름들:
to measure the epidermal growth factor receptors (EGFR)
다른 이름들:
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Patients With Pathological Complete Response.
기간: at 24 weeks
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Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
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at 24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Median Time to Progression of Target Lesions
기간: Every 12 weeks from on-study to disease progression
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Time frame from study entry till discontinuation of treatment due to disease progression.
Progression of target lesions is measured by RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
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Every 12 weeks from on-study to disease progression
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Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)
기간: at 24 weeks
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Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions and partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions.
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at 24 weeks
|
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Number of Patients With Worst-grade Toxicities Per Grade
기간: at 24 weeks
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Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death
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at 24 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
2003년 11월 1일
기본 완료 (실제)
2008년 12월 1일
연구 완료 (실제)
2008년 12월 1일
연구 등록 날짜
최초 제출
2008년 2월 8일
QC 기준을 충족하는 최초 제출
2008년 2월 8일
처음 게시됨 (추정)
2008년 2월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 8월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 8월 3일
마지막으로 확인됨
2012년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VICC BRE 0303
- VU-VICC-BRE-0303
- VU-VICC-030592
- GENENTECH-VU-VICC-BRE-0303
- NOVARTIS-VU-VICC-BRE-0303
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. .