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Immunotherapy combo shows promise in tough breast cancer

NCT ID NCT04085276

Disease control Sponsor: Shanghai Junshi Bioscience 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding the immunotherapy drug toripalimab to standard chemotherapy (nab-paclitaxel) helps people with metastatic or recurrent triple-negative breast cancer live longer without their cancer growing. The study included 531 participants and compared the combination to chemotherapy alone. The main goal was to see if the combination delays cancer progression, especially in patients whose tumors have a specific marker (PD-L1).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Toripalimab (an immunotherapy drug) combined with nab-paclitaxel (a chemotherapy drug)
What this could lead to
If successful, this combination could offer a new treatment option that slows cancer growth in people with metastatic triple-negative breast cancer.
What could go wrong
This is a completed phase 3 trial, but results are not yet widely available. Immunotherapy can cause immune-related side effects, and not all patients may benefit.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

531 people

The number who actually took part.

Started

Dec 2018

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: Metastatic or recurrent triple negative breast cancer (TNBC); * Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-); * Eligible for taxane monotherapy; * No more than one line of chemotherapy in metastatic setting; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Life expectancy of 12 weeks or more; * At least one measurable lesion per RECIST v1.1; * Demonstrate adequate hematologic and organ functions as defined in the protocol Exclusion Criteria: Prior treatment with taxane as first line treatment; * Prior treatment with PD-1 antibody, PD-L1 antibody, PD-L2 antibody, or CTLA4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway) * MRI assessment during screening or previous imaging studies confirmed active or untreated brain metastases. Patients previously treated with local treatment of brain metastases has been stable for ≥ 1 month, and have stopped systemic hormonal therapy (\>10 mg/d prednisone or equivalent) \> 4 weeks before randomization can participate in the study; * Meningeal carcinomatosis; * Pregnancy or lactation; * Active hepatitis B or hepatitis C.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

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

Triple-negative breast cancer

Contacts and locations

Locations

  • Affiliated Hospital of Chengde Medical University

    Chengde, China

  • Affiliated Hospital of Hebei University

    Baoding, China

  • Affiliated Hospital of Jiangnan University（Wuxi NO.4 People's Hospital）

    Wuxi, China

  • Anhui Province Hospital & The First Affiliated Hospital of USTC

    Hefei, China

  • Beijing Hospital

    Beijing, Beijing Municipality, China

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Ürümqi, China

  • Changhai Hospital

    Shanghai, China

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, China

  • Chongqing Cancer Hospital

    Chongqing, China

  • Fujian Medical University Union Hospital

    Fuzhou, China

  • General Hospital of Ningxia Medical University

    Yinchuan, China

  • Guangdong General Hospital

    Guangzhou, China

  • Harbin Medical University Cancer Hospital

    Harbin, China

  • Henan Cancer Hospital

    Zhengzhou, China

  • Henan Provincial People's Hospital

    Zheng'zhou, China

  • Hubei Cancer Hospital

    Wuhan, China

  • Hunan Cancer Hospital

    Changsha, China

  • Jiangsu Cancer Hospital

    Nanjing, China

  • Jiangsu Province Hospital

    Nanjing, China

  • Jiangxi Cancer Hospital

    Nanchang, China

  • Jilin Cancer Hospital

    Changchun, China

  • Liaoning Cancer Hospital&Intitute

    Shenyang, China

  • Linyi Cancer Hospital

    Linyi, China

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, China

  • Shandong Cancer Hospital

    Jinan, China

  • Shanghai General Hospital

    Shanghai, China

  • Sichuan Cancer Hospital

    Chengdu, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, China

  • The Affiliated Hospita of Inner Mongolia Medical University

    Hohhot, China

  • The Affiliated Hospita of of Southwest Medical University

    Luzhou, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, China

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100071, China

  • The First Affiliated Hospital Zhejiang University

    Hangzhou, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, China

  • The First Hospital of China Medical University

    Shenyang, China

  • The First Hospital of Jilin University

    Changchun, China

  • The First People's Hospital of Foshan

    Foshan, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, China

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

    Xi'an, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, China

  • The Second Hospital of Anhui Medical University

    Hefei, China

  • The Second Hospital of Dalian Medical University

    Dalian, China

  • The Third Hospital of Nanchang

    Nanchang, China

  • The Women and Children's Hospital of Guangdong Province

    Guangzhou, China

  • The first affiliated Hospital of Bengbu Medical College

    Bengbu, China

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, China

  • Xiangyang Central Hospital

    Xiangyang, China

  • Yunnan Cancer Hospital

    Kunming, China

  • Zhejiang Cancer Hospital

    Hangzhou, China

More trials for these conditions

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