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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355520
Recruitment Status : Unknown
Verified February 2020 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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 advanced breast cancer.

Condition or disease Intervention/treatment Phase
HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer Drug: TQ-B3525 Drug: Fulvestrant injection Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: TQ-B3525 tablets combined with fulvestrant injection
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.
Drug: TQ-B3525
TQ-B3525 tablets were taken orally, once daily in 28-day cycle; The doses were 20 mg and 30 mg.

Drug: Fulvestrant injection
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.




Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) [ Time Frame: up to 28 days ]
    Subjects appear the toxic reaction relate to the drug after treatment within 28 days.


Secondary Outcome Measures :
  1. Overall response rate (ORR) assessed by investigator [ Time Frame: up to 72 weeks ]
    Percentage of participants achieving complete response (CR) and partial response (PR).

  2. Disease control rate(DCR) [ Time Frame: up to 72 weeks ]
    Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).

  3. Duration of Response (DOR) [ Time Frame: up to 72 weeks ]
    DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

  4. Progression-free survival (PFS) [ Time Frame: up to 72 weeks ]
    PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.

  5. Overall survival (OS) [ Time Frame: up to 72 weeks ]
    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.

  6. 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. ]
    Cmax is the maximum plasma concentration of TQ-B3525 or metabolite(s).

  7. 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. ]
    To characterize the pharmacokinetics of TQ-B3525 by assessment of time to reach maximum plasma concentration.

  8. 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. ]
    To characterize the pharmacokinetics of TQ-B3525 by assessment of time to reach maximum plasma concentration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355520


Contacts
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Contact: Binghe Xu, Doctor 010-87788826 xubinghe@medmail.com.cn

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Contact: Binghe Xu, Doctor    010-87788826    xubinghe@medmail.com.cn   
Principal Investigator: Binghe Xu, Doctor         
China, Hunan
Hunan Cancer Hospital
Changsha, Hunan, China, 410600
Contact: Quchang Ouyang, Doctor       oyqc1969@126.com   
Principal Investigator: Quchang Ouyang, Doctor         
China, Jilin
The First Hospital of Jilin university
Changchun, Jilin, China, 130021
Contact: Wei Li, Doctor       jdyylw@163.com   
Principal Investigator: Wei Li, Doctor         
China, Liaoning
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110042
Contact: Tao Sun, Doctor       lnzlrxnsy@163.com   
Principal Investigator: Tao Sun, Doctor         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04355520    
Other Study ID Numbers: TQ-B3525-I-02
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs