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

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

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.

Study Overview

• Status: Completed
• Conditions: HR-positive, HER2-negative Advanced Breast Cancer
• Intervention / Treatment: Drug: TQB3616 capsules; Drug: Fulvestrant injection

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100039
      • The Fifth Medical Center of PLA General Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400000
      • Chongqing University Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Gansu Provincial Hostipal
  • Guangdong
    • Guangzhou, Guangdong, China, 510062
      • Sun yat-sen University Cancer Center
    • Guangzhou, Guangdong, China, 510062
      • Guangdong General Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Affiliated Tumor Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • The Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Medical University Affiliated Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
  • Liaoning
    • Dalian, Liaoning, China, 116027
      • The Second Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital & Institute
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200123
      • Shanghai East Hospital
  • Shanxi
    • Xi’an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiao Tong University
    • Xi’an, Shanxi, China, 710038
      • The Second Affiliated Hospital of PLA Air Force Military Medical University
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830000
      • Affiliated Tumor Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB3616 capsules combined with fulvestrant injection; TQB3616 capsules 180 mg given orally, once daily in 28-day cycle. 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.	Drug: TQB3616 capsules; TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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]
Clinical benefit rate (CBR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	Baseline up to 24 months
Duration of Response (DOR)	The time when the participants first achieved complete or partial remission to disease progression.	Baseline up to 24 months

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Fulvestrant
• Other Study ID Numbers: TQB3616-II-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No