A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment (kalitERA)
2026年9月15日 更新者：Hoffmann-La Roche
A Phase IIIb, Single-arm, Open-Label, Multicenter Study Evaluating the Treatment Adherence, Tolerability, and Patient-Reported Outcomes of Giredestrant in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant.
The study will have two cohorts. Cohort A will comprise a broad upfront patient population with low-, medium-, or high-risk eBC. Cohort B will comprise patients with medium- or high-risk eBC who have completed adjuvant treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) (abemaciclib or ribociclib) and endocrine therapy and who are now switching to giredestrant monotherapy.
調査の概要
研究の種類
介入
入学 (推定)
1500
段階
- フェーズ 3
アクセスの拡大
利用可能 臨床試験外。
拡張アクセス記録をご覧ください。
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究連絡先のバックアップ
- 名前：Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.
- 電話番号：888-662-6728 (U.S. Only)
- メール：global-roche-genentech-trials@gene.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer
- Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and/or sentinel lymph node biopsy)
- Participants must have completed any prior adjuvant chemotherapy before enrollment, if given
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
- Adequate organ function
- Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist
Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
- Diagnosis of inoperable locally advanced or Stage IV breast cancer
- History of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS)
- Planned surgery during the study
- Prior treatment with giredestrant, selective estrogen receptor degraders (SERDs), or investigational endocrine agents
- Active cardiac disease or history of cardiac dysfunction
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：非ランダム化
- 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：Cohort A: Upfront Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
|
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
他の名前：
|
|
実験的：Cohort B: Switch Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
|
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
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 |
時間枠 |
|---|---|
|
Incidence of Participants who Have Discontinued Giredestrant for any Reason
時間枠：Month 12
|
Month 12
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence and Severity of Adverse Events (AEs)
時間枠：Up to approximately 5 years
|
Up to approximately 5 years
|
|
Treatment Adherence, as Measured by Dose Intensity
時間枠：Up to approximately 5 years
|
Up to approximately 5 years
|
|
Treatment Adherence, as Measured by Treatment Duration
時間枠：Up to approximately 5 years
|
Up to approximately 5 years
|
|
Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for the Overall Endocrine Symptom Burden as Assessed by FACT-ES Endocrine Symptom Subscale Score
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in the Overall Endocrine Symptom Burden Score as Assessed by FACT-ES Endocrine Symptom Subscale Score
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Pain as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Composite Score
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Pain as Assessed by the BPI-SF Pain Severity Composite Score
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Percentage of Participants Reporting Each Response Option for the Treatment Side-Effect Bother Single-Item GP5 (General Physical Well-Being Item 5) as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Change From Baseline in the Treatment Side-Effect Bother Single-Item GP5 as Assessed by FACT-G
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort B: Percentage of Participants Achieving Improvement in Joint Pain Score as Assessed by FACT-ES
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Endocrine Therapy-Specific Symptom Burden as Assessed by the FACT-ES Endocrine Symptom Subscale Score
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Severity Composite Score
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Interference Composite Score
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Global Treatment Bother as Assessed by the Single-Item GP5 From the FACT-G
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort A: Mean Absolute Score for Physical Function as Assessed by the European Organization for Research and Treatment of Cancer Item Library 492 (EORTC IL 492)
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Physical Function Score as Assessed by EORTC IL 492
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Role Function as Assessed by EORTC IL 492
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Role Function Score as Assessed by EORTC IL 492
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Cognitive Function as Assessed by EORTC IL 492
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Cognitive Function Score as Assessed by EORTC IL 492
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Health-Related Quality of Life (HRQoL) as Assessed by EORTC IL 492
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in HRQoL Score as Assessed by EORTC IL 492
時間枠：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Physical Function as Assessed by EORTC IL 492
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Role Function as Assessed by EORTC IL 492
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Cognitive Function as Assessed by EORTC IL 492 Subscale Score
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in HRQoL as Assessed by EORTC IL 492 Subscale Score
時間枠：Month 6 and Month 12
|
Month 6 and Month 12
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Clinical Trials、Hoffmann-La Roche
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月30日
一次修了 (推定)
2028年11月30日
研究の完了 (推定)
2032年11月30日
試験登録日
最初に提出
2026年9月15日
QC基準を満たした最初の提出物
2026年9月15日
最初の投稿 (実際)
2026年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18日
QC基準を満たした最後の更新が送信されました
2026年9月15日
最終確認日
2026年9月1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
- BO46775
- 2026-526742-27-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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
はい
米国FDA規制機器製品の研究
いいえ
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。