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Clinical Trials List

Protocol NumberSTML-ELA-0422
Active

2025-02-28 - 2032-06-30

Phase III

Recruiting13

ICD-10C50.911

Malignant neoplasm of unspecified site of right female breast

ICD-10C50.912

Malignant neoplasm of unspecified site of left female breast

ICD-10C50.919

Malignant neoplasm of unspecified site of unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.9

Malignant neoplasm of female breast, unspecified

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Parexel International

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chiun-Sheng Huang 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭集慶 無
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張耀仁 Division of General Surgery
Taipei Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Wen Chen 無
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shin-Cheh Chen Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾奇峰 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 俞志誠 無
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Liang-Chih Liu 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳守棟 無
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Feng Hou
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Early breast cancer that is lymph node–positive, estrogen receptor–positive, and human epidermal growth factor receptor 2 (HER2)–negative, with a high risk of recurrence.

Objectives

Primary Objective: • To evaluate the efficacy of elacestrant compared with standard endocrine therapy in participants with early breast cancer that is lymph node–positive, estrogen receptor–positive, HER2-negative, and at high risk of recurrence, as measured by invasive breast cancer–free survival (IBCFS). Key Secondary Objectives: • To evaluate the efficacy of elacestrant compared with standard of care (SoC) in terms of distant recurrence–free survival (DRFS). • To evaluate the efficacy of elacestrant compared with SoC in terms of overall survival (OS). Secondary Objectives: • To evaluate the efficacy of elacestrant compared with SoC in terms of invasive disease–free survival (IDFS). • To assess the safety of elacestrant in the study population. • To evaluate the impact of elacestrant compared with SoC on patient-reported outcomes (PROs). • To investigate the steady-state pharmacokinetics (PK) and exposure–response relationships (efficacy and safety) of elacestrant in a subset of participants enrolled at U.S. clinical trial sites.

Test Drug

Elacestrant

Active Ingredient

Elacestrant dihydrochloride

Dosage Form

116

Dosage

345 mg and 86 mg

Endpoints

Primary Endpoint:
• Invasive Breast Cancer–Free Survival (IBCFS): Defined as the time from the date of randomization to the first occurrence of any of the following events:
○ Ipsilateral invasive breast tumor recurrence,
○ Local or regional invasive breast cancer recurrence,
○ Distant recurrence,
○ Contralateral invasive breast cancer, or
○ Death from any cause.

Inclution Criteria

Key Inclusion Criteria:
• Histologic or cytologic confirmation of estrogen receptor (ER)–positive (immunohistochemistry [IHC] ≥10%) and human epidermal growth factor receptor 2 (HER2)–negative [IHC = 0 or 1, or (IHC = 2 and in situ hybridization [ISH] negative)] invasive breast cancer from tumor biopsy or final surgical specimen obtained from early resection. Participants must have no evidence of recurrence or distant metastasis as determined by the local laboratory, in accordance with American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.

• Participants who have received at least 24 months but not more than 60 months of endocrine therapy (aromatase inhibitor [AI] or tamoxifen), with or without concomitant CDK4/6 inhibitor (CDK4/6i) and/or luteinizing hormone–releasing hormone (LHRH) agonist therapy. Participants previously treated with a CDK4/6i or poly(ADP-ribose) polymerase (PARP) inhibitor must have completed or discontinued such therapy before enrollment.

Exclusion Criteria

Key Exclusion Criteria:
• Participants with inflammatory breast cancer.
• Participants with any prior history of invasive breast cancer (ipsilateral and/or contralateral).
• Participants who have had a continuous interruption of prior standard-of-care (SoC) adjuvant endocrine therapy for more than 6 months, or who have discontinued adjuvant endocrine therapy for more than 6 months before randomization.

The Estimated Number of Participants

  • Taiwan

    47 participants

  • Global

    4220 participants

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