Triple Negative Breast CancerPhase 3NCT05134194

A Study of Camrelizumab in Combination With Chemotherapy Regimen Comparative Chemotherapy Regimen for Metastatic Triple-negative Breast Cancer

A Phase 3 study testing Camrelizumab、Capecitabine/eribulin/gemcitabine/vinorelbine and Capecitabine/eribulin/gemcitabine/vinorelbine in people with Triple Negative Breast Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Triple Negative Breast Cancer
What is being tested?: Camrelizumab、Capecitabine/eribulin/gemcitabine/vinorelbine and Capecitabine/eribulin/gemcitabine/vinorelbine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteChina
Study dates: 17 Jan 2022to 15 Dec 2022
Phase: Phase 3
Are there results?: None posted in the registry

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 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

ECOG Performance Status of 0-1.
Expected lifetime of not less than three months
Metastatic triple negative invasive breast cancer, confirmed by histopathological testing, was diagnosed as triple negative according to the American Society of Clinical Oncology / College of American Pathologists (ASCO / CAP) guidelines for pathological typing.
Target lesions with at least one measurable diameter line were present as judged by the investigator on imaging (RECIST v1.1 criteria).
The major organs function well.
Women of childbearing age were required to have a serum pregnancy study within 7 days prior to first dose and be assessed as nonpregnant. Women of reproductive age subjects were required to agree to a highly effective method of contraception during the study and for 6 months after the last administration of study drug.
Volunteered to join this study, signed informed consent, had good compliance and willing to cooperate with follow-up.

Who cannot join

Known central nervous system (CNS) disease.
Uncontrollable moderate to large amounts of pleural effusion requiring repeated drainage, peritoneal effusion, or pericardial effusion.
Any subject with known or suspected autoimmune disease other than: hypothyroidism due to autoimmune thyroiditis requiring hormone replacement therapy only; Subjects with stable type I diabetes in whom glycemia was controlled.
Within 6 months prior to randomization, the following conditions occurred: myocardial infarction, severe / unstable angina, cardiac insufficiency of NYHA class 2 and above, clinically significant supraventricular or ventricular arrhythmia requiring intervention, and symptomatic congestive heart failure.
Previous or current history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, idiopathic interstitial pneumonia, or evidence of active pneumonia on chest CT screening; Patients with a history of radiation pneumonitis (fibrosis) in the irradiated field were excluded.
History of live attenuated influenza vaccination within 28 days before first dose of study medication or anticipated during the study.

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Human immunodeficiency virus (HIV) infection or known to have acquired immune deficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU / ml; hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or coinfection with hepatitis B and C.
Presence of severe infection including, but not limited to, bacteremia requiring hospitalization, severe pneumonia within 4 weeks prior to first dose; With evidence of active tuberculosis infection within 1 year before drug administration.
Had a diagnosis of any other malignancy within 5 years before study entry, with the exception of adequately treated basal cell carcinoma or squamous cell skin carcinoma, or carcinoma in situ of the cervix.
Major surgery within 28 days before randomization (tissue biopsy required for diagnosis and placement of a central venous catheter operation [PICC] via peripheral venipuncture were permitted).
Patients who had previously received or were ready to undergo allogeneic bone marrow transplantation or solid organ transplantation.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: A Muti-center, Open-label, Randomized, Phase III Study of Camrelizumab Plus Treatment of Physician Choice Versus Treatment of Physician Choice for Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Systemic Chemotherapy Regimens for Advanced/Metastatic Setting

Approximately 104 subjects with recurrent or metastatic IM triple negative breast cancer were planned to be included in the study, and screened eligible subjects were randomly assigned in a 1:1 ratio to treatment with the combination of Camrelizumab and investigator's choice of chemotherapy (test arm), treatment with investigator's choice of chemotherapy (control arm), and the stratification factor was liver metastasis (with vs without). After enrollment, subjects in the test group were treated with Camrelizumab 200 mg IV every 3 weeks for one cycle. The investigator's choice of single agent chemotherapy regimen (capecitabine, eribulin, gemcitabine, or vinorelbine) was every 3 weeks for one cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation at the investigator's discretion.

Conditions: Triple Negative Breast Cancer
Being tested: Camrelizumab、Capecitabine/eribulin/gemcitabine/vinorelbine, Capecitabine/eribulin/gemcitabine/vinorelbine
Medical subject headings: Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Camrelizumab、Capecitabine/eribulin/gemcitabine/vinorelbineDrug
Camrelizumab in combination with capecitabine or eribulin or gemcitabine or vinorelbine
Capecitabine/eribulin/gemcitabine/vinorelbineDrug
Capecitabine or eribulin or gemcitabine or vinorelbine

Study groups in NCT05134194
Study group	Role	What they receive
Arm A	Experimental	Camrelizumab in combination with capecitabine or eribulin or gemcitabine or vinorelbine Receives: Drug: Camrelizumab、Capecitabine/eribulin/gemcitabine/vinorelbine
Arm B	Experimental	Capecitabine or eribulin or gemcitabine or vinorelbine Receives: Drug: Capecitabine/eribulin/gemcitabine/vinorelbine

What is being measured

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

Progression free survival (PFS)
assessed by independent imaging (IRC), according to RECIST v1.1
Measured: Treatment was assessed every 6 weeks after treatment initiation（up to 30 weeks）, regardless of whether treatment was delayed or interrupted, until disease progression or study end, whichever occurred first.

Timeline

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

17 Jan 202215 Dec 2022

First posted24 Nov 2021
Study start17 Jan 2022
Primary completion17 Jan 2022
Study completion15 Dec 2022

Why it stopped: Sponsor R \& D Strategy Adjustment\]

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized in a 1:1 ratio to Arm A (Camrelizumab+Capecitabine or Eribulin or Gemcitabine or Vinorelbine), Arm B (Capecitabine or Eribulin or Gemcitabine or Vinorelbine)
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05134194
Sponsor's protocol ID: SHR-1210-III-327
Status last verified: Apr 2024
First submitted: 9 Nov 2021
Last updated: 16 Apr 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Muti-center, Open-label, Randomized, Phase III Study of Camrelizumab Plus Treatment of Physician Choice Versus Treatment of Physician Choice for Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Systemic Chemotherapy Regimens for Advanced/Metastatic Setting
ClinicalTrials.gov ID: NCT05134194
Acronym / sponsor ID: SHR-1210-III-327
Conditions: Triple Negative Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor R \& D Strategy Adjustment\]
Enrolment: 1 participants (actual)
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 17 Jan 2022 (actual)
Primary completion: 17 Jan 2022 (actual)
Study completion: 15 Dec 2022 (actual)
First posted: 24 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomized in a 1:1 ratio to Arm A (Camrelizumab+Capecitabine or Eribulin or Gemcitabine or Vinorelbine), Arm B (Capecitabine or Eribulin or Gemcitabine or Vinorelbine)

Arm	Type	Receives
Arm A	Experimental	Drug: Camrelizumab、Capecitabine/eribulin/gemcitabine/vinorelbineCamrelizumab in combination with capecitabine or eribulin or gemcitabine or vinorelbine
Arm B	Experimental	Drug: Capecitabine/eribulin/gemcitabine/vinorelbineCapecitabine or eribulin or gemcitabine or vinorelbine

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

ECOG Performance Status of 0-1.
Expected lifetime of not less than three months
Metastatic triple negative invasive breast cancer, confirmed by histopathological testing, was diagnosed as triple negative according to the American Society of Clinical Oncology / College of American Pathologists (ASCO / CAP) guidelines for pathological typing.
Target lesions with at least one measurable diameter line were present as judged by the investigator on imaging (RECIST v1.1 criteria).
The major organs function well.

Key exclusion criteria (11 listed)

Known central nervous system (CNS) disease.
Uncontrollable moderate to large amounts of pleural effusion requiring repeated drainage, peritoneal effusion, or pericardial effusion.
Any subject with known or suspected autoimmune disease other than: hypothyroidism due to autoimmune thyroiditis requiring hormone replacement therapy only; Subjects with stable type I diabetes in whom glycemia was controlled.
Within 6 months prior to randomization, the following conditions occurred: myocardial infarction, severe / unstable angina, cardiac insufficiency of NYHA class 2 and above, clinically significant supraventricular or ventricular arrhythmia requiring intervention, and symptomatic congestive heart failure.
Previous or current history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, idiopathic interstitial pneumonia, or evidence of active pneumonia on chest CT screening; Patients with a history of radiation pneumonitis (fibrosis) in the irradiated field were excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Camrelizumab、Capecitabine/eribulin/gemcitabine/vinorelbineCamrelizumab in combination with capecitabine or eribulin or gemcitabine or vinorelbine	Drug	Arm A
Capecitabine/eribulin/gemcitabine/vinorelbineCapecitabine or eribulin or gemcitabine or vinorelbine	Drug	Arm B

Primary outcome

Progression free survival (PFS)
Time frame: Treatment was assessed every 6 weeks after treatment initiation（up to 30 weeks）, regardless of whether treatment was delayed or interrupted, until disease progression or study end, whichever occurred first.
assessed by independent imaging (IRC), according to RECIST v1.1

Results and safety

The study was stopped early (reason given: Sponsor R \& D Strategy Adjustment\]). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 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: stopped early, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor R \& D Strategy Adjustment\]). Results are not available in the source record.

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?

Progression free survival (PFS) (time frame: Treatment was assessed every 6 weeks after treatment initiation（up to 30 weeks）, regardless of whether treatment was delayed or interrupted, until disease progression or study end, whichever occurred first.). 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 NCT05134194.

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 16 Apr 2024.