A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

JRCT ID: jRCT2031230109

Registered date:03/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast Neoplasms
• Date of first enrollment: 16/12/2022
• Target sample size: 6000
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Korea, Republic of,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Slovakia,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: Imlunestrant
Administered orally.
Other Name: LY3484356
-Drug: Tamoxifen
Administered per local approved label.
-Drug: Anastrozole
Administered per local approved label.
-Drug: Letrozole
Administered per local approved label.
-Drug: Exemestane
Administered per local approved label.

Study Arms
-Experimental: Imlunestrant
Imlunestrant administered orally.
Intervention: Drug: Imlunestrant
-Active Comparator: Investigator's Choice of Endocrine Therapy
Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.
Interventions:
-Drug: Tamoxifen
-Drug: Anastrozole
-Drug: Letrozole
-Drug: Exemestane

Outcome(s)

Primary Outcome

Invasive Disease-Free Survival (IDFS) [ Time Frame: Randomization to recurrence or death from any cause (up to 10 years) ]
IDFS excluding second non-breast primary invasive cancers

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
-Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
-Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
-Must have an increased risk of disease recurrence based on clinical-pathological risk features.
-Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
-Have adequate organ function.

Exclude criteria

-Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
-Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
-Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
-Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone >=5 years ago.
-Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
-Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
-Participants with a history of any other cancer.
-Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05514054