HER2-AR+転移性乳がんにおけるPSMAの評価
18F-DCFPyL PSMA ベースの PET/CT による HER2 陰性、アンドロゲン受容体 (AR) 陽性の転移性乳癌における前立腺特異的膜抗原 (PSMA) の評価
The purpose of this research is to determine the expression of prostate specific membrane antigen (PSMA) in human epidermal growth factor receptor 2 (HER2)-negative, androgen receptor (AR)-positive metastatic breast cancer, and to determine its role in resistance to the anti-androgen, bicalutamide. The investigators hypothesize that PSMA expression will correlate with resistance to anti-androgen therapies, as has been documented in prostate cancer, and this can be used to select patients most likely to benefit from these therapies in future clinical trials. 15 people with HER2-negative, AR-positive metastatic breast cancer will be enrolled and be on study for about 3 days.
調査の概要
詳細な説明
Primary Objective:
- To evaluate the expression of PSMA via 18F-DCFPyL PSMA-based PET/CT in patients with metastatic HER2-negative, AR-positive breast cancer. Expression of PSMA will be quantified using PSMA-based PET imaging using a novel agent, 18F-DCFPyL, as a non-invasive imaging biomarker of tumor neovasculature in HER2-negative, AR-positive metastatic breast cancer.
Secondary Objectives:
- PSMA PET will be compared with the expression of PSMA in CTCs and diagnostic metastatic tissue from patients with HER2-negative, AR-positive metastatic breast cancer.
- PSMA expression will be correlated with clinical benefit (objective response and progression-free survival) to bicalutamide and ribociclib for patients enrolled in NCT03090165.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53705
- University of Wisconsin School of Medicine and Public Health
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients diagnosed with metastatic HER2-negative breast cancer AR expression of ≥ 10%
Exclusion Criteria:
- Other (non-breast) known active malignancy. Participants with previously treated cancers which are in remission or have no evidence of disease are eligible.
- Unable to lie flat during or tolerate PET/CT
- Participants with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
- Women of childbearing potential must not be pregnant or breast feeding (pregnancy test negative within 7 days prior to PET/CT
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：診断
- 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：18F-DCFPyL PSMA-based PET/CT
|
PSMA is highly expressed on prostate cancer and is associated with metastasis and resistance to anti-androgen therapies. Researchers have evaluated the expression of PSMA in the tumor and tumor-associated neovasculature in primary tumors and distant metastases in patients with breast cancer. |
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 |
|---|---|---|
|
PSMA Expression as measured by 18F-DCFPyL SUV
時間枠：up to 3 days
|
Quantitative analysis of 18F-DCFPyL PSMA PET uptake will be performed at the lesion-level. Standardized uptake values (SUV) will be measured by manually drawing a region of interest (ROI) to encompass the entire lesion guided by the lesion extent visualized on conventional imaging. PET SUV based quantitative tumor uptake parameters will be obtained. |
up to 3 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Expression of PSMA in CTCs
時間枠：up to 2 weeks
|
Expression of PSMA in CTCs will be measured via immunofluorescence. |
up to 2 weeks
|
|
Expression of PSMA in diagnostic metastatic tissue
時間枠：up to 3 days
|
PSMA expression in tumors will be semi-quantitatively scored by a study pathologist using published methods including separate assessment of tumor-associated and non-tumor vasculature, with the endothelium highlighted by a CD31 immunostain to facilitate definitive recognition. |
up to 3 days
|
|
Change in PSMA Expression on CTCs after 2 weeks of bicalutamide
時間枠：baseline and up to 2 weeks
|
The change in PSMA expression on CTCs will be measured pre and post treatment via immunofluorescence. |
baseline and up to 2 weeks
|
協力者と研究者
捜査官
- 主任研究者：Amy Fowler, MD, PhD、University of Wisconsin, Madison
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- 2020-0949
- A539300 (その他の識別子：UW Madison)
- SMPH/RADIOLOGY/RADIOLOGY (その他の識別子：UW Madison)
- NCI-2020-07434 (レジストリ識別子：NCI CTRP)
- 2020-0949 (その他の識別子：UW Madison)
- Protocol Version 12/12/2025 (その他の識別子：UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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