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Completed

NCT Number: NCT06570031

ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, HER2-negative breast cancer.

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Key information

Conditions

Hormone Receptor-Positive Breast Cancer Breast Diseases Breast Neoplasms Disease Attributes HER2-negative Breast Cancer Metastatic Breast Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrent Breast Cancer Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Aichi Cancer Center Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with postmenopausal metastatic or recurrent breast cancer
  • Patients with ECOG Performance Status 0 to 1
  • ER-positive, PgR-positive and HER2-negative patients

Exclusion criteria

  • Patients are unable to swallow oral medications
  • Patients with severe complication

Treatment and study plan

ONO-4578

Drug

Specified dose on specified days

letrozole

Drug

Specified dose on specified days

Palbociclib

Drug

Specified dose on specified days

Abemaciclib

Drug

Specified dose on specified days

Primary outcomes

  1. Adverse events

    Time frame: Through study completion, an average of 4 year

  2. Serious adverse events

    Time frame: Through study completion, an average of 4 year

  3. Dose-limiting toxicity (Tolerability Confirmation part only)

    Time frame: 28 days

  4. Laboratory abnormality profile of Drugs as measured by incidence and severity of clinical laboratory abnormalities

    Time frame: Through study completion, an average of 4 year

  5. Body temperature

    Time frame: Through study completion, an average of 4 year

  6. Pulse rate

    Time frame: Through study completion, an average of 4 year

  7. Systolic/diastolic blood pressure

    Time frame: Through study completion, an average of 4 year

  8. Saturation of Percutaneous Oxygen (SpO2)

    Time frame: Through study completion, an average of 4 year

  9. Weight

    Time frame: Through study completion, an average of 4 year

  10. Eastern Cooperative Oncology Group Performance Status

    Time frame: Through study completion, an average of 4 year

  11. Chest X-ray

    Time frame: Through study completion, an average of 4 year

  12. CT scan

    Time frame: Through study completion, an average of 4 year

  13. 12-lead electrocardiography (Heart rate)

    Time frame: Through study completion, an average of 4 year

  14. 12-lead electrocardiography (PR interval)

    Time frame: Through study completion, an average of 4 year

  15. 12-lead electrocardiography (RR interval)

    Time frame: Through study completion, an average of 4 year

  16. 12-lead electrocardiography (QRS width)

    Time frame: Through study completion, an average of 4 year

  17. 12-lead electrocardiography (QT interval)

    Time frame: Through study completion, an average of 4 year

Secondary outcomes

  1. Overall response rate (ORR)

    Time frame: Through study completion, an average of 4 year

  2. Disease control rate (DCR)

    Time frame: Through study completion, an average of 4 year

  3. Clinical benefit rate (CBR)

    Time frame: Through study completion, an average of 4 year

  4. Overall survival (OS)

    Time frame: Through study completion, an average of 4 year

  5. Progression-free survival (PFS)

    Time frame: Through study completion, an average of 4 year

  6. Duration of response (DOR)

    Time frame: Through study completion, an average of 4 year

  7. Time to response (TTR)

    Time frame: Through study completion, an average of 4 year

  8. Best overall response (BOR)

    Time frame: Through study completion, an average of 4 year

  9. Percent change in the sum of diameters of target lesions

    Time frame: Through study completion, an average of 4 year

  10. Maximum percent change in the sum of diameters of target lesions

    Time frame: Through study completion, an average of 4 year

  11. Changes in tumor markers

    Time frame: Through study completion, an average of 4 year

  12. Plasma ONO-4578 concentration

    Time frame: Through study completion, an average of 4 year

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

ONO-4578-06: Phase I , Open-label, Non-blind, First-line Endocrine Therapy With ONO-4578 and Standard Treatment Letrozole and CDK4/6 Inhibitors (Palbociclib or Abemaciclib) in Patients With Metastatic or Recurrent Postmenopausal Hormone Receptor-positive HER2-negative Breast Cancer

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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