A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC
A Phase II Randomized Study of Palbociclib in Combination With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer
Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC, in the last decade there was no major improvement of hormonal therapy specifically for premenopausal metastatic breast cancer. The median age of breast cancer is much younger, and the proportion of young breast cancer (YBC) patients (less than 40) including premenopausal women is much higher, in Asia, including Korea.
Capecitabine, the comparator in this trial, is an orally-administered fluoropyrimidine derivative and has shown high efficacy and low toxicity in metastatic breast cancer patients. Palbociclib is a CDK4/6 inhibitors, in combination with endocrine therapy showed marked advance in hormone receptor-positive MBC in the post-menopausal setting. After a median follow-up of 16.5 months, preliminary results from Part 1 of this Phase 2 trial suggest that the combination of PD-0332991 with letrozole is superior to letrozole alone, and improved objective response and disease control rates (52% vs 32% and 76% vs 47%, respectively) in patients treated with the combination. These remarkable results may contribute to have much benefit with endocrine therapy for premenopausal women. Most importantly, recent PALOMA-3 trial revealed superior results of adding palbociclib to fulvestrant (median PFS 9.2 vs 3.8 months, P<0.001).
Based on these rational backgrounds, the purpose of this phase II study is to assess the safety and the clinical anti-tumor activity of exemestane plus goserelin acetate in combination with palbociclib vs capecitabine in premenopausal hormone receptor-positive advanced breast cancer patients
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Seoul、大韓民国、135-710
- Samsung Medical Center
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Seoul、大韓民国
- Samsung Medical Center
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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:
- Histologically confirmed metastatic breast cancer with measurable or evaluable disease: Patients who have progressed on distant metastatic sites after curative surgery or have stage IV breast cancer at diagnosis
- Age > 19 years
- ECOG performance status 0 - 2
- Patient has HER2-negative breast cancer with IHC and/or FISH (or SISH, CISH) Patient has ER positive and/or PgR positive breast cancer by local laboratory testing
Patient is premenopausal. Premenopausal status is defined as either:
A. Patient had last menstrual period within the last 12 months B. If within three months of tamoxifen (tamoxifen) taking, C. In case of chemotherapy induced amenorrhea, the serum FSH ≤40IU/l
- A. Patient who have stage IV breast cancer at diagnosis, allow disease that progressed after 1st line chemotherapy. B. Patient who have stage IV breast cancer at diagnosis, allow disease that progressed after tamoxifen or goserelin. C. In case of recur/metastatic breast cancer, allow disease that progressed after 12 month of completion of neo/adjuvant chemotherapy .
- Urine or serum HCG test must be negative.
- Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
- Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
- Patients who were already established on bisphosphonate therapy may continue on bisphosphonates.
- Patients agreed to use effective contraception or not of childbearing potential
- Written informed consent
- Consent to biomarker analysis.
Exclusion Criteria:
- Postmenopausal women
- Serious uncontrolled intercurrent infections
- Serious intercurrent medical or psychiatric illness, including active cardiac disease
- Pregnancy or breast feeding
- Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or resected thyroid papillary carcinoma or other malignancy treated at least 5 years previously with no evidence of recurrence)
- Patients has received previous endocrine treatments such as, aromatase inhibitor, exemestane in the metastatic setting
- Patients has received previous treatment with CDK 4/6 inhibitors, mTOR inhibitors, PIK3CA inhibitors or capecitabine
- No symptomatic visceral metastasis
- Known brain metastases unless treated and stable
- Clinically significant uncontrolled conditions including, known active hepatitis B or hepatitis C.
- QTc interval > 480 msec, family or personal history of long or short QT syndrome, or known history of QTc prolongation or Torsade de Pointes.
- Known positive testing for human immunodeficiency virus or acquired immune deficiency syndrome.
- Unable to swallow and retain oral medication.
- Treatment radiotherapy within 4 weeks of the study
- Use of any investigational drug within 4 weeks of the study
- Treatment with chemotherapy within 3 weeks or hormone therapy within 2 weeks of the study
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:ランダム化
- 介入モデル:並列代入
- 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 |
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アクティブコンパレータ:カペシタビン
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Capecitabine 1,250mg/m2 bid orally form day1 to day 14 q 3weeks
他の名前:
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実験的:Palbociclib + Exemestane + GnRH agonist
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Palbociclib 125mg, orally once daily on D1 to D21 followed by 7days off
他の名前:
Exemestane 25mg, orally once daily
他の名前:
Leuprolide Acetate 3.75mg SC q 4weeks
他の名前:
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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 |
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Progression free survival (PFS) in patients with metastatic breast cancer who received palbociclib plus exemestane with goserelin versus capecitabine
時間枠:1year
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1year
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協力者と研究者
スポンサー
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 (予想される)
研究の完了 (予想される)
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
- 2015-08-042
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。
転移性乳がんの臨床試験
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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
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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
Palbociclibの臨床試験
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University of Texas Southwestern Medical CenterUniversity of Pennsylvania; Pfizer完了
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Borstkanker Onderzoek Groep積極的、募集していない