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NCT Number: NCT03481998

A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant. Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for study.

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Key information

Conditions

Advanced 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 1 / Phase 2

Primary location

Ha'erbin Tumor Hospital, Harbin, Heilongjiang, China

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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, postmenopausal women.prepostmenopausal women, but should receive Ovary castration.

Inclusion criteria

  • Cohort 1 and Cohort 2 :No prior systemic anti-cancer therapy for advanced HR+ disease.

Cohort 3 and Cohort 4 : Patients must satisfy the following criteria for prior therapy:

  • a) Progressed after 2 years during treatment of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or perimenopausal.

b)Progressed within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or perimenopausal.

c) Progressed while 6 month after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer if postmenopausal, or prior endocrine treatment for advanced/metastatic breast cancer if pre- or perimenopausal.

  • One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy.
  • Eastern Cooperative Oncology Group [ECOG] 0-1 Measurable disease as per Response Evaluation Criterion in Solid Tumors[RECIST] 1.1
  • Adequate organ and marrow function

Exclusion criteria

  • Confirmed diagnosis of HER2 positive disease
  • Patients who received any endocrine therapy as neo/adjuvant therapy for breast cancer are eligible. If the neo/adjuvant therapy of any endocrine therapy , the disease-free interval must be greater than 12 months from the completion of treatment until study entry.
  • Patients who received prior treatment with any CDK4/6 inhibitor, everolimus,fulvestant.
  • 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.
  • Has known active central nervous system metastases.

Treatment and study plan

SHR6390

Drug

SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Letrozole or anastrozole or Fulvestrant

Drug

Letrozole 2.5mg or anastrozole 1mg, orally once daily (continuously)， or Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease

Primary outcomes

  1. Number of Participants With adverse events (AEs) and serious adverse events (SAEs) at Phase 1

    Time frame: Up to 4 weeks

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

    Up to 24 months.

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of SHR6390

    Time frame: Up to 4 weeks

  2. Peak Plasma Concentration (Cmax) of SHR6390

    Time frame: Up to 4 weeks

  3. The time of SHR6390 to reach the maximum concentration (Tmax)

    Time frame: Up to 4 weeks

  4. Half-time (t1/2) of SHR6390

    Time frame: Up to 4 weeks

  5. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Time frame: Up to approximately 24 months.

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ¡Ý30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

  6. Progression-free Survival (PFS) per RECIST 1.1

    Time frame: Up to approximately 24 months.

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.

  7. Disease Control Rate (DCR) per RECIST 1.1

    Time frame: Up to approximately 24 months.

    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.

  8. Number of Participants With adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to approximately 24 months.

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase IB/II to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2018
Registry last updated
Nov 21, 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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