Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer
Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the 12-month change in breast density in postmenopausal women with ductal carcinoma in situ (DCIS) or stage I-III breast cancer treated with adjuvant anastrozole.
Secondary
- Determine the change in estrone sulfate levels in patients treated with this drug.
- Correlate the change in breast density with the change in circulating estrone sulfate levels in patients treated with this drug.
- Determine the frequency of polymorphisms in aromatase (CYP19) and evaluate the relationship between wild-type aromatase enzyme with change in breast density and change in estrone sulfate levels in patients treated with this drug.
- Determine the 12-month change in bone density, and correlate it with the change in circulating estrone sulfate levels in patients treated with this drug.
- Correlate the reversal of hypermethylation with change in circulating estrone sulfate levels and breast density in patients treated with this drug.
OUTLINE: This is a pilot study. Patients are stratified according to concurrent bisphosphonate use (yes vs no).
Patients receive oral anastrozole once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
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
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer meeting 1 of the following criteria:
- Ductal carcinoma in situ (DCIS)
Invasive carcinoma
- Stage I-III disease
Must have undergone breast cancer surgery within the past 6 months, including any of the following:
- Mastectomy or lumpectomy with or without radiation
- Sentinel node and/or axillary node dissection
- Re-excision of lumpectomy margins
Intact contralateral breast
- No prior radiation therapy or mastectomy
- Prior biopsies allowed
Hormone receptor status:
- Estrogen and/or progesterone receptor-positive tumor by immunohistochemical staining
PATIENT CHARACTERISTICS:
Sex
- Female
Menopausal status
Postmenopausal, defined as 1 of the following:
- At least 60 years of age
- Less than 60 years of age and amenorrheic ≥ 12 months prior to study entry
- Less than 60 years of age, amenorrheic for < 12 months prior to day 1, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range
- Less than 60 years of age, without a uterus, and LH and FSH values within postmenopausal range
- Underwent prior bilateral oophorectomy
- Underwent prior radiation castration AND amenorrheic for ≥ 6 months
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior or concurrent adjuvant chemotherapy for breast cancer
Endocrine therapy
- No prior aromatase inhibitor
- At least 6 weeks since prior and no concurrent tamoxifen
At least 6 weeks since prior and no concurrent hormone replacement therapy
- Concurrent low-dose, local vaginal estrogen in the form of either a conjugated estrogen ring or other similar product (e.g., Estring® or Vagifem®) allowed
- At least 6 weeks since prior and no other concurrent selective estrogen receptor modulators (e.g., raloxifene)
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
- No contralateral breast implant
Other
- Concurrent bisphosphonates allowed at the discretion of the treating oncologist
No concurrent consumption of soy supplements
- Concurrent routine dietary consumption of soy-containing foods allowed
- No other concurrent investigational or commercial drugs or therapies for the treatment of DCIS or invasive breast cancer
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:Anastrozole
Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
|
1 mg orally daily for 12 months
他の名前:
treatment received after 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 |
時間枠 |
---|---|
Change in breast density after 12 months of treatment
時間枠:12 months
|
12 months
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Change in hormone levels after 12 months of treatment
時間枠:12 months
|
12 months
|
Comparison between change in breast density with change in hormone levels after 12 months of treatment
時間枠:12 months
|
12 months
|
Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment
時間枠:12 months
|
12 months
|
Comparison between change in bone density with change in hormone levels after 12 months of treatment
時間枠:12 months
|
12 months
|
Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment
時間枠:12 months
|
12 months
|
協力者と研究者
捜査官
- スタディチェア:Vered Stearns, MD、Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
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 (見積もり)
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
- J0365 CDR0000446285
- P30CA006973 (米国 NIH グラント/契約)
- JHOC-J0365 (その他の識別子:SKCCC at Johns Hopkins)
- JHOC-SKCCC-J0365 (その他の識別子:SKCCC at Johns Hopkins)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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