High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy
Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy.
PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the clinical response rate in postmenopausal women with estrogen and/or progesterone receptor-positive metastatic breast cancer that has failed prior sequential endocrine therapy treated with high-dose esterified estrogens (Menest^®).
Secondary
- Determine time to disease progression in patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
OUTLINE: Patients receive oral high-dose esterified estrogens (Menest^®) 3 times daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 2 months.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 2 years.
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
-
-
Illinois
-
Chicago、Illinois、アメリカ、60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
-
-
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
- Metastatic disease
Documented disease progression
Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer
- Disease progression during adjuvant tamoxifen is considered 1 prior therapy
- The 2 most recent treatments must have been endocrine agents
- At least 1 objective measurable disease parameter
Brain metastases allowed provided both of the following criteria are met:
- Brain metastases were previously treated AND are currently stable
- Brain metastases are not the only site of metastatic disease
Hormone receptor status
- Estrogen and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
Postmenopausal, as defined by any of the following:
- At least 50 years of age with an intact uterus AND amenorrheic for the past 12 months
- At least 50 years of age without a uterus AND follicle-stimulating hormone (FSH) level within postmenopausal range
- Under 50 years of age and FSH level within postmenopausal range
- Prior bilateral oophorectomy
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- Adequate hematologic function
Hepatic
- Adequate hepatic function
- Bilirubin ≤ 1.5 times upper limit of normal
- No history of hepatic adenoma
Renal
- Adequate renal function
- No history of hypercalcemia or severe hypocalcemia
Cardiovascular
- No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use
- No active thrombophlebitis or thromboembolic disorders
- No history of uncontrolled hypertension
Other
- Not pregnant
- No undiagnosed abnormal vaginal bleeding
- No other serious medical illness
- No psychiatric illness that would preclude giving informed consent
- No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Prior chemotherapy for metastatic disease allowed
- Prior adjuvant chemotherapy allowed
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- Prior radiotherapy allowed provided the only site of measurable disease was not irradiated
Surgery
- Not specified
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
- マスキング:なし(オープンラベル)
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 |
---|
臨床反応率
|
二次結果の測定
結果測定 |
---|
毒性
|
病気の進行までの時間
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:William J. Gradishar, MD、Robert H. Lurie Cancer Center
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NCI 03B5
- NU-03B5
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。
乳がんの臨床試験
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ