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

CTTQ

Status and phase: Unknown; Phase 2

Conditions: HR-positive, HER2-negative Advanced Breast Cancer

Treatments: Drug: Fulvestrant injection; Drug: TQB3616 capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT04796623

TQB3616-II-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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:

  2. Has other malignant tumors within 3 years;

  3. Has multiple factors affecting oral medication;

  4. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;

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

  6. Cirrhosis, active hepatitis#

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

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  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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

TQB3616 capsules combined with fulvestrant injection

Experimental group

Description:

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.

Treatment:

Drug: Fulvestrant injection

Drug: TQB3616 capsules