New hope for breast cancer patients whose tumors resisted standard therapy

NCT ID NCT06702618

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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

    Jinan, Shandong, 250117, China

  • Hai'an People's Hospital

    Nantong, Jiangsu, 226600, China

  • Harbin Medical University Cancer Hostipal

    Harbin, Heilongjiang, 150000, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410010, China

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529000, China

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210003, China

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110000, China

  • Luohe Central Hospital

    Luohe, Henan, 462000, China

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000, China

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

    Xi’an, Shanxi, 710061, China

  • The First Affilliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233000, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300202, China

  • Xingtai People's Hospital

    Xingtai, Hebei, 54000, China

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