AzTrials
AzTrials

Breast CancerPhase 2NCT06702618

Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer

A Phase 2 study testing TQB3616 capsule+Fulvestrant Injection in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 13 sites in China.

Active, not recruiting

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

Official record
Search all trials

Trial summary

Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative Recurrent/Metastatic Breast Cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer
What is being tested?
TQB3616 capsule+Fulvestrant Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
13 sitesChina
Study dates
20 Feb 2025to Dec 2026
Phase
Phase 2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily join the study, sign the informed consent form, and have good compliance
  • Aged 18 to 75 years, with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0~1; expected survival time of more than 3 months.
  • Postmenopausal or premenopausal/perimenopausal female patients
  • Progressed after prior treatment with CDK4/6 inhibitors
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Good major organ function
  • Women of childbearing potential must agree to use contraception during the study and for 6 months after its completion.

Who cannot join

  • Subjects with a previous pathological diagnosis of HER2-positive breast cancer.
  • Subjects with inflammatory breast cancer or occult breast cancer.
  • Subjects who have had or currently have other malignant tumors within 5 years prior to randomization.
  • Subjects with unresolved toxicity (greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1) from prior treatment, excluding alopecia.
  • Subjects who have undergone major surgical procedures, incisional biopsies, or significant traumatic injuries within 28 days prior to the first dose.
  • Subjects with non-tumor-related unresolved wounds, ulcers, or fractures.
Show all 20Show fewer
  • Subjects with multiple factors affecting oral medication intake and absorption.
  • Subjects with arterial or deep vein thrombotic events within 6 months prior to the first dose.
  • Subjects with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia, angina requiring anti-anginal medication, clinically significant valvular heart disease, or uncontrolled hypertension.
  • Subjects with a history of interstitial lung disease/pneumonitis (non-infectious) requiring steroid intervention or currently having interstitial lung disease/pneumonitis, or subjects with suspected interstitial lung disease/pneumonitis on screening imaging that cannot be excluded.
  • Subjects with active or uncontrolled serious infections (≥CTCAE Grade 2 infection) or unexplained fever >38.5°C within 28 days prior to the first dose.
  • Subjects with a history of abuse of psychotropic drugs that cannot be abstained from or those with psychiatric disorders.
  • Subjects with (pseudo) cirrhosis, active hepatitis.
  • Subjects with renal failure requiring hemodialysis or peritoneal dialysis.
  • Subjects with a history of immunodeficiency diseases, organ transplants, or hematopoietic stem cell transplants.
  • Subjects who have previously received fulvestrant or other oral Selective Estrogen Receptor Degrader (SERD) class drugs.
  • Subjects who have previously received anti-HER2 therapy.
  • Subjects who have previously received antibody-drug conjugate therapy.
  • Subjects who have participated in other anti-tumor clinical trials and taken investigational drugs within 4 weeks prior to the first dose.
  • Subjects judged by the investigator to have serious accompanying diseases that severely endanger the safety of the subject or affect the completion of the study, or subjects who are deemed unsuitable for enrollment for other reasons

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • The First Affilliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233000

  • Hunan Cancer Hospital

    Changsha, Hunan, 410010

  • Harbin Medical University Cancer Hostipal

    Harbin, Heilongjiang, 150000

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529000

  • Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)

    Jinan, Shandong, 250117

  • Luohe Central Hospital

    Luohe, Henan, 462000

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210003

  • Hai'an People's Hospital

    Nantong, Jiangsu, 226600

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110000

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300202

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi’an, Shanxi, 710061

  • Xingtai People's Hospital

    Xingtai, Hebei, 54000

Other trials in China

About this study

Official title: Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined With Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6（CDK4/6)Inhibitor-Resistant, Hormone Receptor(HR)-Positive, Human Epidermal Growth Factor Receptor 2(HER2)-Negative Recurrent/Metastatic Breast Cancer

Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative Recurrent/Metastatic Breast Cancer.

Conditions
Breast Cancer
Being tested
TQB3616 capsule+Fulvestrant Injection
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 capsule+Fulvestrant InjectionDrug

    TQB3616 capsule is a CDK2/4/6 inhibitor and Fulvestrant injection is an anti-estrogen medication, and its pharmacological mechanism mainly exerts its therapeutic effect by inhibiting the action of aromatase.

Study groups in NCT06702618
Study groupRoleWhat they receive
TQB3616 capsule+Fulvestrant InjectionExperimentalNot described
Receives: Drug: TQB3616 capsule+Fulvestrant Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    The proportion of patients achieving complete response and partial response among the total evaluable cases.

    Measured: Baseline up to 12 months

Secondary outcomes (6)

  1. Progression Free Survival

    Progression Free Survival (PFS) is defined as the length of time from the start of treatment until the disease progresses or the patient dies from any cause.

    Measured: Baseline up to 12 months

  2. Duration of Response

    The time from the first assessment of the tumor as a complete response or partial response to the first occurrence of disease progression or death from any cause.

    Measured: Baseline up to 12 months

  3. Disease Control Rate

    The percentage of subjects with a complete response, partial response, or stable disease as determined by RECIST 1.1.

    Measured: Baseline up to 12 months

  4. Clinical Benefit Rate

    The percentage of subjects with a complete response, partial response, or stable disease for ≥24 weeks as determined by RECIST 1.1.

    Measured: From the first dose to complete response, partial response, or stable disease for ≥24 weeks

  5. Overall Survival

    The time from the start of initial treatment to death from any cause

    Measured: Baseline up to 24 months

  6. Adverse event (AE)

    Incidence and severity of adverse events

    Measured: From the subject's signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start20 Feb 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06702618
Sponsor's protocol ID
TQB3616-II-04
Status last verified
Apr 2026
First submitted
20 Nov 2024
Last updated
9 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 2 study testing TQB3616 capsule+Fulvestrant Injection in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 13 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 7 inclusion and 20 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 9 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 13 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?

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?

Objective Response Rate (time frame: Baseline up to 12 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 NCT06702618.

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 9 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in