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NCT Number: NCT04842617

Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative

The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.

To observe the PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postmenopausal or premenopausal/perimenopausal female patients aged ≥18 years and ≤75 years old.
  • Pathological examination diagnosed as invasive breast cancer with HR+ and HER2-.
  • Underwent radical resection of breast cancer.
  • The score of ECOG was 0 - 1.
  • Fertile women must have a negative serum pregnancy test within 7 days before randomization, and be willing to use acceptable non hormonal contraceptive measures.
  • With my consent and informed consent, I am willing and able to comply with the planned visit, study treatment plan, laboratory examination and other test procedures.

Exclusion criteria

  • This Pathological examination diagnosed as HER2-positive breast cancer.
  • The history of any malignant tumor other than breast cancer within 5 years before randomization.
  • At the same time participate in other anti-tumor therapy clinical trials (including endocrine therapy or immunotherapy, etc.).
  • In the 6 months before randomization, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, , etc
  • Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug.
  • There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study.

Treatment and study plan

SHR6390

Drug

SHR6390 combined with endocrine therapy

Placebo

Drug

placebo combined with endocrine therapy

Primary outcomes

  1. IDFS（Invasive Disease-Free Survival）

    Time frame: at least 5 years from the date of randomization .

Secondary outcomes

  1. DFS(Disease-Free Survival)

    Time frame: The observation time is at least 5 years from the date of randomization . Evaluations were conducted every 26 weeks for the first 2 years and every 52 weeks thereafter, with a follow-up of at least 5 years.

  2. OS(Overall Survival)

    Time frame: up to approximately 5 years.

  3. DDFS(Distant Disease-Free Survival)

    Time frame: from randomization to distant recurrence or death from any cause, whichever occurs first. Evaluations were conducted every 26 weeks for the first 2 years and every 52 weeks thereafter, with a follow-up of at least 5 years.

  4. Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

    Time frame: up to approximately 5 years

    To evaluate the safety and tolerability of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative female breast cancer.

  5. Plasma concentration of SHR6390 will be analyzed for PK samples

    Time frame: collected on day 1 of the 5th, 9th, 13th and 17th weeks, respectively.

    To explore the PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative female breast cancer.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind Phase III Study：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Apr 13, 2021
Registry last updated
Aug 1, 2024

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.