Breast CancerPhase 3NCT05780567
Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
A Phase 3 study testing TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites in China.
Trial summary
This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,946 participants
- Where
- 3 sitesChina
- Study dates
- 30 Mar 2023to Jan 2027
- Phase
- Phase 3
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
- The subjects voluntarily joined the study and signed the informed consent, with good compliance.
- Age: 18-75 years old (upon signing the informed consent); Eastern Cooperative Oncology Group Performance Status (PS) score: 0~1;
- Surgical treatment of radical mastectomy;
- Pathological examination confirmed HR positive and HER2 negative invasive breast cancer;
- The major organs are functioning well, meeting the following criteria：
- Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：
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- Hemoglobin (HB) ≥90 g/L；
- Neutrophil absolute value (NEUT) ≥ 1.5×109/L；
- Platelet count (PLT) ≥ 100 ×109/L；
- Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)；
- Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN；
- Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60 ml/min；
- Blood clotting tests must meet the following criteria (no anticoagulant therapy)：
- Prothrombin time (PT) ≤ 1.5×ULN;
- Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
- International Normalized ratio (INR) ≤ 1.5×ULN.
- Left ventricular ejection fraction (LVEF) ≥50%.
Who cannot join
- Complicated diseases and medical history:
- Has had other malignant tumors within 5 years or currently has other malignant tumors;
- Have a variety of factors that affect oral medication (such as inability to swallow);
- Current history of serious lung disease such as interstitial pneumonia；
- Severe infections common terminology criteria for adverse events (≥CTCAE (common terminology criteria for adverse events) 2 grade) that were active or uncontrolled before the study treatment started (Except hair loss and hemoglobin)；
- Known allergy to aromatase inhibitors, tamoxifen, TQB3616/ placebo, or any excipients;
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- There was a history of live attenuated vaccine vaccination within 28 days prior to randomization or live attenuated vaccine vaccination was planned during the study period;
- Participated in clinical trials of other antitumor agents within 4 weeks prior to randomization；
- The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of study participation or interfere with the study results, as well as subjects who are deemed unsuitable for study participation for other reasons by the investigator.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 300020
Suining Central Hospital
Suining, Sichuan, 629099
About this study
Official title: Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy
This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Approximately 1946 female subjects will be randomized to either TQB3616 combined with endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo Comparator group.
- Conditions
- Breast Cancer
- Being tested
- TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen, Placebo capsules, Letrozole, Anastrozole, Tamoxifen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3616 capsules, Letrozole, Anastrozole, TamoxifenDrug
TQB3616 is a novel Cyclin-dependent kinase (CDK) 4/6 inhibitor and currently being used in the treatment of a variety of malignant solid tumors.
Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.
Placebo capsules, Letrozole, Anastrozole, TamoxifenDrug
Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| TQB3616 capsules combined with endocrine | Experimental | The dose of TQB3616 capsules is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle.
The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle.
The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle.
The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle. Receives: Drug: TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen |
| placebo combined with endocrine | Placebo comparator | The dose of placebo is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle.
The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle.
The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle.
The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle. Receives: Drug: Placebo capsules, Letrozole, Anastrozole, Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-Free Survival (IDFS)
The time from the date of randomization to the first occurrence of the following events, including ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, secondary primary malignancy outside the breast, and death from any cause.
Measured: Baseline up to 60 months
Secondary outcomes (8)
Overall survival (OS)
The time from first administration to death of any cause.
Measured: Baseline up to 60 months
Disease Relapse Free Survival (DRFS)
The time from the date of randomization to the first occurrence of distant recurrence or death from any cause.
Measured: Baseline up to 60 months
Incidence of adverse events
Incidence of adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Measured: Baseline up to 60 months
Severity of adverse events
Severity of adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Measured: Baseline up to 60 months
Incidence of abnormal laboratory test values
Incidence of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE).
Measured: Baseline up to 60 months
Severity of abnormal laboratory test values
Severity of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE).
Measured: Baseline up to 60 months
Incidence of serious adverse events
Incidence of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Measured: Baseline up to 60 months
Severity of serious adverse events
Severity of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Measured: Baseline up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start30 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,946 participants (estimated)
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
- NCT05780567
- Sponsor's protocol ID
- TQB3616-III-03
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No