Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial
Pilot Study: Evaluation of Novel Data-Driven Outcomes Via Response-Guided Systems Medicine in Hormone Receptor-Positive Advanced Breast Cancer (ENDORSE)
調査の概要
状態
条件
詳細な説明
PRIMARY OBJECTIVE:
I. To assess the feasibility and utility of using a systems medicine approach to evaluate tumor tissue from patients with hormone receptor-positive HER2-negative unresectable metastatic breast cancer after progression on first line therapy to both predict estrogen dependence and aid in selection of effective standard of care therapy.
SECONDARY OBJECTIVES:
I. To determine the accrual rate (AR). II. To measure the clinical benefit rate (CBR). III. To compare progression free survival (PFS) based on concordance with recommended treatment.
IV. To determine the duration of response (DoR). V. To measure the therapy acceptance rate (TAR).
EXPLORATORY OBJECTIVES:
I. To obtain additional genomic, epigenomic, and transcriptomic data on resistance mechanisms that informs future validation studies, artificial intelligence (AI) model-selected next line of therapy selection with anticipated highest efficacy amongst available options, and advanced AI model development.
II. To assess obstacles to enrollment and pitfalls of the study design to guide future studies.
OUTLINE:
Patients have their tumor tissue analyzed. Their physician receives a report based on their tumor biology consisting of their predicted ongoing response to endocrine therapy, predicted ongoing response to endocrine therapy plus PIK3CA mutation or ESR1 mutation or HER2 mutation or mTOR sensitivity/resistance. The report includes treatment recommendations and the results of the specific tests completed on the tumor tissue. Physicians then determine a treatment regimen for the patient that may or may not include the treatment recommended in the report. Patients undergo blood sample collection and computed tomography (CT) scan or magnetic resonance imaging (MRI) and/or bone scan and/or positron emission tomography (PET) scan throughout the study. Patients may undergo tumor biopsy during screening and may optionally undergo at progression.
After completion of study intervention, patients are followed every 3 months until disease progression.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope Medical Center
-
主任研究者：
- Irene M. Kang
-
コンタクト：
- Irene M. Kang
- 電話番号：844-756-2047
- メール：ikang@coh.org
-
Irvine、California、アメリカ、92618
- City of Hope at Irvine Lennar
-
主任研究者：
- Irene M. Kang
-
コンタクト：
- Irene M. Kang
- 電話番号：844-756-2047
- メール：ikang@coh.org
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Participant must speak English
Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Age: ≥ 18 years
- Patients must have histologically confirmed, unresectable or metastatic hormone receptor positive, HER2 breast cancer. Hormone receptor positive is defined as estrogen receptor >= 10% and/or progesterone receptor >= 10%. Her2 negative per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines
Patient must have disease progression during or after prior endocrine therapy meeting one of the following criteria:
- Disease progression on 1st line endocrine therapy for advanced/metastatic breast cancer.
- Disease progression on or within 2 years of completion of treatment with a CDK4/6i in the adjuvant setting for early- stage breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Patient must have at least one lesion amenable to percutaneous core
- Clinically appropriate for biopsy
Exclusion Criteria:
- Prior treatment in the metastatic setting with capecitabine, phosphoinositide 3 kinase (PI3K) inhibitor, mechanistic target of rapamycin (mTOR) inhibitor, protein kinase B (Akt) inhibitor, selective estrogen receptor degrader (SERD), or HER2-targeted therapy, including neratinib
- Known or untreated, or active, brain or leptomeningeal metastases that are deemed inappropriate to pursue therapy guided by systems medicine approach. Enrolled patients may receive radiation or other loco regional therapy prior to initiating systemic therapy on study. History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors not requiring active therapy
- Life expectancy < 1 year
- Pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Treatment (Biology guided therapy report)
Patients have their tumor tissue analyzed.
Their physician receives a report based on their tumor biology consisting of their predicted ongoing response to endocrine therapy, predicted ongoing response to endocrine therapy plus PIK3CA mutation or ESR1 mutation or HER2 mutation or mTOR sensitivity/resistance.
The report includes treatment recommendations and the results of the specific tests completed on the tumor tissue.
Physicians then determine a treatment regimen for the patient that may or may not include the treatment recommended in the report.
Patients undergo blood sample collection and CT scan or MRI and/or bone scan and/or PET scan throughout the study.
Patients may undergo tumor biopsy during screening and may optionally undergo at progression.
|
MRIを受ける
他の名前：
採血を受ける
他の名前：
PETスキャンを受ける
他の名前：
CTスキャンを受ける
他の名前：
補助研究
骨スキャンを受ける
他の名前：
腫瘍生検を受けます
他の名前：
Receive tumor biology report with predicted ongoing response
Receive treatment recommendations
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Turnaround time (feasibility)
時間枠：Up to 30 days.
|
Report consists of an Evaluation of Novel Data-driven Outcomes via Response-guided Systems Medicine in Hormone Receptor-positive Advanced Breast Cancer (ENDORSE) signature score, MTOR signature score and status of other Food and Drug Administration approved biomarkers, including ESR1 mutations, PIK3CA mutations and HER2 mutation/expression).
The turn-around time will be summarized by the range, mean, median, and standard deviation.
|
Up to 30 days.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Accrual rate
時間枠：Up to 1 year
|
Defined as is the number of patients enrolled over the period of a month.
|
Up to 1 year
|
|
Clinical benefit rate
時間枠：At 6 months
|
Will be summarized as the percentage of patients with complete response (CR), partial response (PR), or at least stable disease (SD) at 6 months.
|
At 6 months
|
|
Median progression free survival
時間枠：From study registration to progression, symptomatic deterioration, or death due to any cause, up to 1 year
|
From study registration to progression, symptomatic deterioration, or death due to any cause, up to 1 year
|
|
|
Duration of overall response
時間枠：From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, up to 1 year
|
From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, up to 1 year
|
|
|
Therapy acceptance rate
時間枠：Up to 1 year
|
Defined as the proportion of cases in which the recommended therapy by the study was the same as what was recommended by the physician.
|
Up to 1 year
|
協力者と研究者
捜査官
- 主任研究者：Irene M Kang、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 24121 (その他の識別子：City of Hope Comprehensive Cancer Center)
- P30CA033572 (米国 NIH グラント/契約)
- NCI-2026-02741 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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