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.
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
Drug | Synonyms | Arms |
---|
TQ-B3525 | | TQ-B3525 tablets combined with fulvestrant injection |
Fulvestrant injection | | TQ-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
Name | Type | Description | Interventions |
---|
TQ-B3525 tablets combined with fulvestrant injection | Experimental | TQ-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 21, 2020