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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-04

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HR-positive, HER2-negative Advanced Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TQB3616 capsules

Intervention Type DRUG

TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.

Fulvestrant injection

Intervention Type DRUG

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.

Interventions

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TQB3616 capsules

TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING