HR-positive, HER2-negative Advanced Breast CancerPhase 2NCT04796623
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
A Phase 2 study testing TQB3616 capsules and Fulvestrant injection in people with HR-positive, HER2-negative Advanced Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HR-positive, HER2-negative Advanced Breast Cancer
- What is being tested?
- TQB3616 capsules and Fulvestrant injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 17 sitesChina
- Study dates
- 4 Feb 2021to 24 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Concomitant disease and medical history:
- Has other malignant tumors within 3 years;
- Has multiple factors affecting oral medication;
- Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;
- Has active or uncontrolled severe infections before the first dose;
- Cirrhosis, active hepatitis#
Show all 13Show fewer
- Have a history of immunodeficiency; 2. Tumor-related symptoms and treatment:
- <!-- -->
- Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
- 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;
- 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 and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100039
Hunan Cancer Hospital
Changsha, Hunan, 410013
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027
Guangdong General Hospital
Guangzhou, Guangdong, 510062
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510062
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, 150000
Gansu Provincial Hostipal
Lanzhou, Gansu, 730030
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi’an, Shanxi, 710038
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061
About this study
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
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.
- Being tested
- TQB3616 capsules, Fulvestrant injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3616 capsulesDrug
TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.
Fulvestrant injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TQB3616 capsules combined with fulvestrant injection | Experimental | 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. Receives: Drug: TQB3616 capsules; Drug: Fulvestrant injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 24 months
Secondary outcomes (4)
Progression free survival (PFS)
PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Measured: 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.
Measured: Baseline up to 24 months]
Clinical benefit rate (CBR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: Baseline up to 24 months
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start4 Feb 2021
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR-positive, HER2-negative Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796623
- Sponsor's protocol ID
- TQB3616-II-01
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04796623
- Acronym / sponsor ID
- TQB3616-II-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3616 capsules combined with fulvestrant injection | Experimental | Drug: TQB3616 capsules, Drug: Fulvestrant injectionTQB3616 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 1. Concomitant disease and medical history:
- <!-- -->
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3616 capsulesTQB3616 capsules 180 mg given orally, once daily in 28-day cycle. | Drug | TQB3616 capsules combined with fulvestrant injection |
| Fulvestrant injectionFulvestrant 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 combined with fulvestrant injection |
Primary outcome
Overall response rate (ORR) assessed by investigator
Time frame: Baseline up to 24 months
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.
4 secondary outcomes
Progression free survival (PFS)
Time frame: Baseline up to 24 months
Overall survival (OS)
Time frame: Baseline up to 24 months]
Clinical benefit rate (CBR)
Time frame: Baseline up to 24 months
Duration of Response (DOR)
Time frame: Baseline up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
Related trials for HR-positive, HER2-negative Advanced Breast Cancer
Not yet recruitingPhase 1
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
Breast Cancer, Hormone-receptor-positive Breast Cancer
RecruitingPhase 1
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
PIK3CA Mutations, Advanced Solid Tumors, Adult
RecruitingPhase 1
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
Solid Tumor, Adult, Metastatic Breast Cancer
RecruitingPhase 3
Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment
Breast Cancer, HR-positive Breast Cancer
Not yet recruitingPhase 3
A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer
HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB3616 capsules and Fulvestrant injection in people with HR-positive, HER2-negative Advanced Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) assessed by investigator (time frame: Baseline up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.