A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
AN INTERVENTIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF ATIRMOCICLIB (PF-07220060) PLUS GIREDESTRANT COMPARED TO GIREDESTRANT MONOTHERAPY AS ADJUVANT TREATMENT IN ADULT PARTICIPANTS WITH ESTROGEN RECEPTOR (ER)-POSITIVE, HER2-NEGATIVE EARLY-STAGE BREAST CANCER WITH MEDIUM OR HIGH RISK OF RECURRENCE (FOURLIGHT-4)
This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or high risk of recurrence.
This is a Phase 3, double blind, placebo controlled study of atirmociclib plus giredestrant vs. giredestrant monotherapy as adjuvant treatment in adult patients with ER+, HER2- early breast cancer. The study plans to enroll 3800 participants randomized 1:1 into one of two treatment arms (Arm A - investigational: atirmociclib plus giredestrant taken continuously in a 28-day cycle) or (Arm B - comparator: placebo plus giredestrant taken continuously in a 28-day cycle). Participants may be treated with atirmociclib/placebo up to 3 years and giredestrant up to 5 years followed by long term follow up for survival and evaluation of recurrence of disease.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Pfizer CT.gov Call Center
- 電話番号：1-800-718-1021
- メール：ClinicalTrials.gov_Inquiries@pfizer.com
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
KEY INCLUSION CRITERIA
-
Histologically confirmed unilateral primary adenocarcinoma of the breast
- ER-positive by local assessment
- documented HER2-negative
-
Node positive or node negative as defined by:
-
Pathological node positive (microscopic and/or macroscopic tumor involvement >/=pN1)
-
pN0 and pT >1cm with at least one of the following:
- pT4N0 or
- histologically Grade 3 disease or
- high-risk classification based on genomic assay
-
-
Randomization within 16 months of definitive breast surgery
-
If indicated, completed adjuvant and/or neoadjuvant chemotherapy, adjuvant radiation therapy >/= 21 days prior to randomization
KEY EXCLUSION CRITERIA
-
Distant metastases of breast cancer beyond regional lymph nodes
-
Multicentric or multifocal breast cancer if any tumor foci meet pathologic criteria for ER(-) or HER2(+)
-
Clinically significant cardiovascular disease or cardiac repolarization abnormality for 6 months prior to randomization; resting heart rate <50bpm
-
Has received the following prior systemic anti-cancer therapy for breast cancer
- prior atirmociclib, giredestrant, other investigational anti-cancer agent
- prior treatment with olaparib
NOTES:
- short course of prior neo/adjuvant CDK4/6 inhibitor treatment (</=8 weeks) is permitted; 10-day washout period required
- short course of prior neoadjuvant and/or adjuvant ET (</=18 weeks) is permitted; 35-day washout period for tamoxifen is required
-
Prior treatment with investigational product within 30 days or 5 half-lives
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm A : Atirmociclib + giredestrant
Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day |
Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day
他の名前：
giredestrant capsule given once a day |
|
アクティブコンパレータ：Arm B: Placebo for atirmociclib + giredestrant
Placebo atirmociclib tablets given orally twice a day plus giredestrant capsule given once a day |
giredestrant capsule given once a day Atirmociclib placebo tablet given twice a day |
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 |
|---|---|---|
|
Invasive Breast Cancer Free Survival (iBCFS)
時間枠：From randomization to first iBCFS event, up to 16 years
|
iBCFS is defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria |
From randomization to first iBCFS event, up to 16 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Invasive Disease Free Survival (iDFS)
時間枠：From randomization to first iDCFS event, up to 16 years
|
iDFS defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, second primary invasive non-breast cancer, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria |
From randomization to first iDCFS event, up to 16 years
|
|
Disease Recurrence Free Survival (DRFS)
時間枠：From randomization to first DRFS event, up to 16 years
|
DRFS as per investigator assessment, defined as the time from the date of randomization to the date of distant recurrence as determined by investigator assessment or death from any cause, whichever occurs first |
From randomization to first DRFS event, up to 16 years
|
|
Overall survival (OS)
時間枠：From randomization to death from any cause, up to 16 years
|
OS is defined as the time from the date of randomization to the date of death due to any cause |
From randomization to death from any cause, up to 16 years
|
|
Number and percentage of Participants with Treatment-Emergent Adverse Events (AEs)
時間枠：From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
Type, incidence, severity of AE graded by NCI CTCAE v 5.0, seriousness and relationship to study intervention |
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
Percentage of participants With Clinical Laboratory Abnormalities
時間枠：From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
|
Percentage of Participants With ECG abnormalities
時間枠：From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
|
Patient Reported Outcomes (PRO)
時間枠：From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
Change from baseline in participant reported total score, well-being subscales and symptoms scores and TOI per FACT-ES |
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
Pre-dose Plasma Concentration (Ctrough) of atirmociclib
時間枠：Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; Cycle is defined as 28 days
|
Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; Cycle is defined as 28 days
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Pfizer CT.gov Call Center、Pfizer
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 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
- C4391026
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?
IPD プランの説明
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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
米国FDA規制機器製品の研究
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。