Clinical Trials /

A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer

NCT04355520

Description:

This is a open-label, multicenter phase Ib study to evaluate safety and efficacy of TQ-B3525 tablets combined with fulvestrant injection in subjects with HR-positive, HER2-negative and PIK3CA mutation advanced breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
  • Official Title: A Phase Ib, Single-arm, Open-label Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: TQ-B3525-I-02
  • NCT ID: NCT04355520

Conditions

  • HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer

Interventions

DrugSynonymsArms
TQ-B3525TQ-B3525 tablets combined with fulvestrant injection
Fulvestrant injectionTQ-B3525 tablets combined with fulvestrant injection

Purpose

This is a open-label, multicenter phase Ib study to evaluate safety and efficacy of TQ-B3525 tablets combined with fulvestrant injection in subjects with HR-positive, HER2-negative and PIK3CA mutation advanced breast cancer.

Trial Arms

NameTypeDescriptionInterventions
TQ-B3525 tablets combined with fulvestrant injectionExperimentalTQ-B3525 tablets were taken orally, once daily in 28-day cycle; fulvestrant injection 500mg administered intravenously (IV) on day 1, day 15 of first cycle and on day 1 of follow-up treatment cycle. Each cycle is 28 days.
  • TQ-B3525
  • Fulvestrant injection

Eligibility Criteria

        Inclusion Criteria:

          -  1. Histopathologically confirmed breast cancer. 2. Hormone receptor(HR) positive and
             human epidermal growth factor receptor-2 (HER2) negative for primary or metastatic
             tumors confirmed by immunohistochemistry test.

             3. Agree to provide at least 10 unstained sections of tumor tissue obtained within 2
             years (surgery or biopsy) for genetic mutation detection and with PIK3CA mutation
             positive.

             4. Age ≥18 years, postmenopausal women. 5. Inoperable, locally advanced recurrent
             and/or metastatic tumor, and has at least one measurable lesion.

             6. Inappropriate to receive radical resection or radiation therapy. 7. Eastern
             Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

             8. Life expectancy ≥12 weeks. 9. Male or female subjects should agree to use an
             adequate method of contraception starting with the first dose of study therapy through
             6 months after the last dose of study.

             10. Understood and signed an informed consent form.

        Exclusion Criteria:

          -  1. Has known untreated or active CNS metastasis. 2.Previous or co-existing cancers of
             a different site or histology from primary breast cancer.

             3. Inadequate bone marrow hematopoiesis. 4. Abnormal liver function. 5. Renal
             abnormalities. 6. Has bleeding risk. 7. Gastrointestinal disorder. 8.
             Cardio-cerebrovascular anomaly. 9. Previous treatment: A) Has received fulvestrant
             injection; B) Has received PI3K, AKT and mTOR inhibitors; C) Has received anti-tumor
             treatment, including chemotherapy, radiotherapy, hormone therapy, biotherapy,
             immunotherapy, and surgical treatment, less than 4 weeks after the first
             administration; D) Has received oral targeted drugs less than 5 half-lives to the
             first administration; E) Has received palliative radiotherapy for non-target lesions
             within 2 weeks before the first administration; F) Toxicity related to previous
             anti-tumor treatment did not recover to ≤ grade 1, except for hair loss.

             10.Has participated in other clinical trials within 30 days. 11.Has received major
             surgical treatment within 1 month or unhealed traumatic injury.

             12. Has a history of organ transplantation or hematopoietic stem cell transplantation
             within 60 days prior to the first administration.

             13.Immunosuppressant or systemic or absorbable local hormone therapy is required to
             achieve the aim of immunosuppression (dose > 10mg/ day prednisone or other
             therapeutic hormones) and is still used within 2 weeks after the first administration.

             14.Active bacterial or fungal infections diseases. 15.Human immunodeficiency virus
             (HIV) infection. 16.Pregnant or lactating female patients. 17.Has mental and
             neurological diseases. 18. With severe or poorly controlled diseases. 19. Has a
             history of active tuberculosis. 20. Patients have inadequate compliance to participate
             in this study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicity (DLT)
Time Frame:up to 28 days
Safety Issue:
Description:Subjects appear the toxic reaction relate to the drug after treatment within 28 days.

Secondary Outcome Measures

Measure:Overall response rate (ORR) assessed by investigator
Time Frame:up to 72 weeks
Safety Issue:
Description:Percentage of participants achieving complete response (CR) and partial response (PR).
Measure:Disease control rate(DCR)
Time Frame:up to 72 weeks
Safety Issue:
Description:Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measure:Duration of Response (DOR)
Time Frame:up to 72 weeks
Safety Issue:
Description:DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measure:Progression-free survival (PFS)
Time Frame:up to 72 weeks
Safety Issue:
Description:PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Measure:Overall survival (OS)
Time Frame:up to 72 weeks
Safety Issue:
Description:OS defined as the time from the first dose to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Measure:Cmax
Time Frame:Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 1; Hour 0 of day 15; and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 28.
Safety Issue:
Description:Cmax is the maximum plasma concentration of TQ-B3525 or metabolite(s).
Measure:Tmax
Time Frame:Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 1; Hour 0 of day 15; and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 28.
Safety Issue:
Description:To characterize the pharmacokinetics of TQ-B3525 by assessment of time to reach maximum plasma concentration.
Measure:AUC0-t
Time Frame:Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 1; Hour 0 of day 15; and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 28.
Safety Issue:
Description:To characterize the pharmacokinetics of TQ-B3525 by assessment of time to reach maximum plasma concentration.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Last Updated

April 20, 2020