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NCT Number: NCT05979220

Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy

This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chemotherapy.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
  • Age: 18 - 75 years old
  • Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1
  • Functions of liver and kidney is normal
  • Agreed to take contraceptive measures during treatment

Exclusion criteria

  • Confirmed diagnosis of HER2 positive disease.
  • Central nervous system metastasis
  • Patients who received prior treatment with any CDK4/6 inhibitor.
  • Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention；
  • Researchers believe that is not suitable for the study

Treatment and study plan

Dalpiciclib combined with Letrozole

Drug

A multicenter, single arm, prospective Phase II clinical study

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Estimated up to 23 months

    The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause.

Secondary outcomes

  1. Progression Free Survival 2(PFS2)

    Time frame: Estimated up to 27-31 months

    The time from the first chemotherapy for the metastatic stage by the subject to the first recording of tumor progression (evaluated according to RECIST 1.1 standards) or death from any cause.

Other outcomes

  1. Overall Survival(OS)

    Time frame: Estimated up to 5 years

    OS was defined as the time from the first study treatment to the date of death from any cause

  2. Objective Response Rate（ORR）

    Time frame: Estimated up to 23 months

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

  3. Clinical Benefit Rate (CBR)

    Time frame: Estimated up to 23 months

    The percentage of participants who received study treatment and evaluated the best overall efficacy according to RECIST 1.1 criteria as complete remission (CR), partial remission (PR), and disease stability (SD) ≥ 24 weeks.

  4. Disease Control Rate (DCR)

    Time frame: Estimated up to 23 months

    Disease Control Rate (DCR) was defined as the percentage of patients with a complete response (CR), partial response (PR) and stable disease (SD).

  5. Patient Reported Outcome (PRO)

    Time frame: Estimated up to 5 years

    Using the European Five Dimensional Health Scale (EQ-5D) to allow patients to self-evaluate their quality of life

  6. Adverse events (AEs)

    Time frame: Estimated up to 5 years

    The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Luo, post-doctor

CONTACT

[email protected]

18602866299

Xiaorong Zhong, post-doctor

CONTACT

[email protected]

18980605984

Sponsors and collaborators

Lead sponsor

Shuangyue Liu

Other

Registry information

Official study title

A Multicenter, Single Arm, Prospective Phase II Clinical Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy

Important dates

Study start
2023
Primary completion
2024
Study completion
2028
First posted
Aug 7, 2023
Registry last updated
Aug 7, 2023

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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