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New drug combo shows promise against hard-to-treat breast cancer

NCT ID NCT04796623

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new drug (TQB3616) combined with fulvestrant in 122 people with a type of advanced breast cancer (HR-positive, HER2-negative). The goal was to see if the combination could shrink tumors or slow the cancer's growth. Participants had either received one prior treatment or none at all. The trial is complete, and results will help determine if this approach offers better disease control.

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

122 people

The number who actually took part.

Started

Feb 2021

Finished

May 2024

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

Female participants only

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: * 1.Understood and signed an informed consent form. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 3. Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer. 4.Cohort 1: patients had received ≤1 line of treatment. 5.Cohort 2: patients had not previously received systemic antitumor therapy. 6.Has at least one measurable lesion according to RECIST1.1 criteria. 7.Adequate laboratory indicators. Exclusion Criteria: * 1\. Concomitant disease and medical history: 1. Has other malignant tumors within 3 years; 2. Has multiple factors affecting oral medication; 3. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy; 4. Has active or uncontrolled severe infections before the first dose; 5. Cirrhosis, active hepatitis# 6. Have a history of immunodeficiency; 2. Tumor-related symptoms and treatment: <!-- --> 1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis; 2. Had received chemotherapy within 3 weeks prior to the first dose, and had received radiotherapy , hormone therapy, or other anti-tumor therapy within 2 weeks prior to the first dose; 3. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 3\. Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient. 4\. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HR-positive, HER2-negative advanced breast cancer

Contacts and locations

Locations

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000, China

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000, China

  • Gansu Provincial Hostipal

    Lanzhou, Gansu, 730030, China

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510062, China

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021, China

  • Harbin Medical University Affiliated Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042, China

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510062, China

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100039, China

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

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

    Xi’an, Shanxi, 710061, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011, China

  • The Second Affiliated Hospital of PLA Air Force Military Medical University

    Xi’an, Shanxi, 710038, China

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116027, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.