ステージ I ～ III の HER2 陰性浸潤性乳がん患者における腫瘍反応を予測するための遺伝子検査
HER2 陰性の原発浸潤性乳がん (臨床ステージ I ～ III) の化学療法および内分泌感受性のためのゲノム検査の実現可能性、検証、および実施
This phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer. Genetic testing is a procedure that tests tumor samples to learn if certain genes are activated (turned on) in the tumor and if the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.
調査の概要
状態
条件
- 解剖学的ステージ I 乳がん AJCC v8
- 解剖学的ステージ IA 乳がん AJCC v8
- 解剖学的ステージ IB 乳がん AJCC v8
- 解剖学的ステージ II 乳がん AJCC v8
- 解剖学的病期 IIA 乳がん AJCC v8
- 解剖学的ステージ IIB 乳がん AJCC v8
- 解剖学的ステージ III 乳がん AJCC v8
- 解剖学的病期 IIIA 乳がん AJCC v8
- 解剖学的病期 IIIB 乳がん AJCC v8
- 解剖学的病期 IIIC 乳がん AJCC v8
- 予後I期乳がんAJCC v8
- 予後 IA期乳がん AJCC v8
- 予後 IB期乳がん AJCC v8
- 予後 II期乳がん AJCC v8
- 予後 ステージ IIA 乳がん AJCC v8
- 予後 ステージ IIB 乳がん AJCC v8
- 予後 III期乳がん AJCC v8
- 予後 IIIA期乳がん AJCC v8
- 予後 IIIB期乳がん AJCC v8
- 予後 IIIC期乳がん AJCC v8
- 解剖学的ステージ IV 乳がん AJCC v8
- 予後 IV期乳がん AJCC v8
- 浸潤性乳癌
詳細な説明
PRIMARY OBJECTIVE:
I. To determine the feasibility of implementation of molecular (genomic) predictive testing for patients with localized (stage I-III) invasive carcinoma of the breast who are candidates for either adjuvant or neoadjuvant treatment of their breast cancer.
SECONDARY OBJECTIVES:
I. Estimate the frequency of tumors in each of the four molecularly defined cohorts, overall and within subsets defined by nodal status and estrogen receptor (ER) status.
II. Estimate the concordance of genomic analysis of gene expression levels for ER and HER2 from the microarray (published previously), compared with standard testing with immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to determine ER and HER2 status in these tumors.
III. Estimate the rates of indeterminate results and other variables of feasibility for tissue obtained by different procurement methods including: fine needle aspiration, core needle biopsy or surgical resection.
IV. Estimate the impact of adjuvant therapy as measured by disease free survival (DFS) at 3 and 5 years for the patients within each cohort who received a neoadjuvant or adjuvant treatment that is concordant with the application of the prediction result (i.e. chemotherapy [CT] with sequential taxane and anthracycline regimens +/- subsequent endocrine therapy [ET] if hormone receptor-positive) as follows: Group A: ET alone (without CT); Group B: CT followed by ET; Group C: CT alone; Group D: CT, followed by ET if hormone receptor positive.
V. Estimate the impact of neoadjuvant therapy for patients within each cohort, as measured by pathologic response in the breast and regional lymph nodes (pathologic complete response rate [pCR] and residual cancer burden [RCB]).
VI. Estimate the predictive performance of other pre-validated and published genomic predictors of chemotherapy or endocrine therapy sensitivity by calculating those predictions from the microarray data that are produced or by using available results if the test was performed separately for clinical use.
VII. Determine molecular characteristics of residual disease by analyzing resected surgical specimens of residual disease in patients who have received neoadjuvant chemotherapy.
VIII. Determine molecular characteristics of recurrent or metastatic disease by analyzing tumor tissue obtained from diagnostic biopsies of a recurrent or metastatic tumor and comparing these samples to the primary tumor.
OUTLINE:
Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results.
After completion of study, patients are followed up for 5 years.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Texas
-
Houston、Texas、アメリカ、77030
- M D Anderson Cancer Center
-
-
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:
- The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III; stage IV patients will be allowed and included in the feasibility assessment, but will not be included in outcomes analysis for secondary objectives
- The clinical or radiologic primary tumor size is at least 1 cm diameter
Exclusion Criteria:
- The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining
- The patient has received prior systemic therapy or radiation therapy for breast cancer
- The patient has a prior history of invasive or metastatic cancer within 5 years of diagnosis of breast cancer, excluding squamous cell or basal cell carcinoma of the skin
- The patient had prior excisional biopsy of the primary invasive breast cancer
- There is hematoma or biopsy site changes that obscure the primary tumor
- Patients deemed medically ineligible for any adjuvant or neoadjuvant therapy. Patients with ER-positive (+) tumors deemed medically eligible for hormonal therapy, but not chemotherapy will be considered eligible for this protocol. Patients with ER-negative (-) tumors who are not candidates for adjuvant anthracycline based chemotherapy will be considered ineligible for this protocol. Patients who undergo biopsy and are later found to be ineligible for adjuvant therapy will be assessed for the primary objective, but will be excluded from the secondary objectives
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Diagnostic (biopsy, surgery, genetic testing)
Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results. |
Undergo tumor biopsy
他の名前：
Undergo surgery Undergo genetic testing
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 |
|---|---|---|
|
Feasibility defined as the ability to classify patients into 1 of 4 cohorts
時間枠：Up to 5 years
|
The study will use the methods of Thall et al. to monitor the ability to classify patients into 1 of 4 groups (success rate) throughout the trial. Will use summary statistics to describe the demographic and clinical characteristics of patients overall and within each subgroup (Groups A-D). |
Up to 5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease-free survival (DFS)
時間枠：Time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years
|
The study will estimate 3-year DFS with 95% confidence intervals within each subgroup (Groups A-D) using the Kaplan-Meier estimator. Will also use a Cox proportional hazards regression model to estimate the association between DFS and subgroup, genomic predictions of treatment response, treatment, age at diagnosis, tumor stage at diagnosis, clinical nodal status at diagnosis, and histologic grade. |
Time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years
|
|
Frequency of tumors
時間枠：Up to 5 years
|
The study will estimate the relative frequency of tumors classified within each prediction cohort (groups A-D) with 95% confidence intervals. |
Up to 5 years
|
|
Concordance of genomic analysis with immunohistochemistry (IHC)
時間枠：Up to 5 years
|
The study will tabulate the estrogen receptor (ER) status and Her2 status of tumors as determined by the genomic analysis and by IHC. Will estimate the concordance between these 2 methods for ER status and for Her2 status with 95% confidence intervals. |
Up to 5 years
|
|
Indeterminate Results
時間枠：Up to 5 years
|
The study will use descriptive statistics to summarize the data in an effort to understand reasons for obtaining indeterminate results when trying to classify patients into 1 of the 4 subgroups (Groups A-D). Will summarize these data overall and separately for each biopsy method (e.g., fine needle aspiration, core needle biopsy, surgical resection). |
Up to 5 years
|
協力者と研究者
捜査官
- 主任研究者：Senthilkumar Damodaran、M.D. Anderson Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (推定)
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
- 2011-0007
- 2011-0007 (その他の識別子：M D Anderson Cancer Center)
- NCI-2018-02476 (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
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