Status:
UNKNOWN
A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04355520
Start Date
July 1 2020
End Date
September 1 2021
Last Update
April 21 2020
Active Locations (4)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410600
3
The First Hospital of Jilin university
Changchun, Jilin, China, 130021
4
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110042