A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer

HR-positive, HER2-negative Advanced Breast Cancer Clinical Trial

Official title:

A Open-label, Multicenter Phase II Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative Advanced Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04796623
• Other study ID #: TQB3616-II-01
• Status: Recruiting
• Phase: Phase 2
• Start date: February 4, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2021
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced and/or metastatic breast cancer, including Cohort 1 and Cohort 2. Each cohort will enroll 30-60 cases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1.Understood and signed an informed consent form. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy = 3 months. 3. Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer. 4.Cohort 1: patients had received =1 line of treatment. 5.Cohort 2: patients had not previously received systemic antitumor therapy. 6.Has at least one measurable lesion according to RECIST1.1 criteria. 7.Adequate laboratory indicators.

Exclusion Criteria:

• 1. Concomitant disease and medical history:

1. Has other malignant tumors within 3 years;

2. Has multiple factors affecting oral medication;

3. Unalleviated toxicity = grade 1 due to any previous anticancer therapy;

4. Has active or uncontrolled severe infections before the first dose;

5. Cirrhosis, active hepatitis#

6. Have a history of immunodeficiency; 2. Tumor-related symptoms and treatment:

1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;

2. Had received chemotherapy within 3 weeks prior to the first dose, and had received radiotherapy , hormone therapy, or other anti-tumor therapy within 2 weeks prior to the first dose;

3. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

3. Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.

4. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Related Conditions & MeSH terms

• Breast Neoplasms
• HR-positive, HER2-negative Advanced Breast Cancer

Intervention

Drug:
• TQB3616 capsules
TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.
• Fulvestrant injection
Fulvestrant injection was given at a fixed dose of 500mg on day 1, day 15 of the first cycle and day 1 of each subsequent cycle, and each cycle is 28 days.

Locations

Country	Name	City	State
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Harbin Medical University Affiliated Cancer Hospital	Harbin	Heilongjiang
China	Gansu Provincial Hostipal	Lanzhou	Gansu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi
China	Shanghai East Hospital	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Affiliated Tumor Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	The First Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shanxi
China	The Second Affiliated Hospital of PLA Air Force Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR) assessed by investigator	ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.	Baseline up to 24 months
Secondary	Progression free survival (PFS)	PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.	Baseline up to 24 months
Secondary	Overall survival (OS)	OS defined as the time from 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.	Baseline up to 24 months]
Secondary	Clinical benefit rate (CBR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	Baseline up to 24 months
Secondary	Duration of Response (DOR)	The time when the participants first achieved complete or partial remission to disease progression.	Baseline up to 24 months