New hope for breast cancer patients whose tumors resisted standard therapy
NCT ID NCT06702618
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 study tests a new drug (TQB3616) combined with hormone therapy for people with a common type of breast cancer (HR-positive, HER2-negative) that has returned or spread and no longer responds to a standard class of drugs called CDK4/6 inhibitors. The trial enrolls 33 adults aged 18-75 who have already tried a CDK4/6 inhibitor. The main goal is to see if the tumor shrinks or disappears, and researchers also track how long the benefit lasts.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, 250117, China
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Hai'an People's Hospital
Nantong, Jiangsu, 226600, China
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Harbin Medical University Cancer Hostipal
Harbin, Heilongjiang, 150000, China
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Hunan Cancer Hospital
Changsha, Hunan, 410010, China
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Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
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Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210003, China
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Liaoning Cancer Hospital
Shenyang, Liaoning, 110000, China
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Luohe Central Hospital
Luohe, Henan, 462000, China
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The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
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The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061, China
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The First Affilliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300202, China
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Xingtai People's Hospital
Xingtai, Hebei, 54000, China
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