Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance (POWER PIINC)
調査の概要
状態
詳細な説明
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.
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
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute
-
-
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:
- 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
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：All patients
All patients enrolled in the study.
|
All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.
Breast cancer surgery
|
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 |
|---|---|---|
|
Change in Ki67 Expression in Tumors
時間枠：7 days
|
Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.
|
7 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in FACT-ES Symptom Scores
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in FACT-ES Symptom Scores
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Leigh Neumayer, MD、Huntsman Cancer Institute
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
- HCI57098
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