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AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
Are there results?
Not yet: the study is under way

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

Other trials in China

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 groups in NCT05780567
Study groupRoleWhat they receive
TQB3616 capsules combined with endocrineExperimentalThe 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 endocrinePlacebo comparatorThe 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.

  1. 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)

  1. Overall survival (OS)

    The time from first administration to death of any cause.

    Measured: Baseline up to 60 months

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted22 Mar 2023
  2. Study start30 Mar 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 18 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 17 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 3 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Invasive Disease-Free Survival (IDFS) (time frame: Baseline up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05780567.

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 17 Apr 2026.

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