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

Plain English Summary

A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer is a Phase 2 clinical trial sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. studying HR-positive, HER2-negative Advanced Breast Cancer. This trial tested a combination of TQB3616 capsules and Fulvestrant injection. It was for adults with advanced or metastatic breast cancer that is HR-positive and HER2-negative. Participants took TQB3616 capsules daily and received Fulvestrant injections on a specific schedule. Standard treatments for this type of breast cancer include hormone therapy and chemotherapy. The trial aims to enroll 122 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You could join if you have advanced or metastatic breast cancer that is HR-positive and HER2-negative. You must have a good general health status (ECOG 0-1) and a life expectancy of at least 3 months. You could not join if you had other active cancers, severe uncontrolled infections, or significant liver problems. You also could not join if you had brain metastases or had received certain cancer treatments recently. This trial is studying HR-positive, HER2-negative Advanced Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal was to see how many patients responded to the treatment, meaning their tumors shrank or disappeared, as assessed by the study doctors. The specific primary outcome measures are: Overall response rate (ORR) assessed by investigator (Baseline up to 24 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a need for new treatment options for patients with advanced HR-positive, HER2-negative breast cancer, a common subtype for which resistance to existing therapies can develop. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets HR-positive, HER2-negative Advanced Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial investigated a novel combination therapy for a significant segment of the breast cancer market, potentially offering a new treatment option if successful and approved. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this combination therapy is suitable for your specific type of breast cancer and if it's different from your current treatment. Participation involved taking daily pills and receiving regular injections, with regular visits for check-ups and assessments. Be prepared for potential side effects and discuss any concerns with your healthcare team. The trial is being conducted at 17 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 122 participants

Interventions

• 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.

Primary Outcomes

• Overall response rate (ORR) assessed by investigator (Baseline up to 24 months)

Secondary Outcomes

• Progression free survival (PFS) (Baseline up to 24 months)
• Overall survival (OS) (Baseline up to 24 months])
• Clinical benefit rate (CBR) (Baseline up to 24 months)
• Duration of Response (DOR) (Baseline up to 24 months)

Full Eligibility Criteria

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:

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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 Locations

• The Fifth Medical Center of PLA General Hospital, Beijing, Beijing Municipality, China
• Chongqing University Cancer Hospital, Chongqing, Chongqing Municipality, China
• Gansu Provincial Hostipal, Lanzhou, Gansu, China
• Guangdong General Hospital, Guangzhou, Guangdong, China
• Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
• Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guangxi, China
• The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
• Harbin Medical University Affiliated Cancer Hospital, Harbin, Heilongjiang, China
• Hunan Cancer Hospital, Changsha, Hunan, China
• Jiangsu Province Hospital, Nanjing, Jiangsu, China
• ...and 7 more locations

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• HER2-Negative Breast Cancer
• Metastatic Breast Cancer
• Advanced Breast Cancer
• Endocrine Therapy Resistance
• Hormonal Therapy
• Oncology
• Cancer Treatment
• Clinical Trials

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