Triple Negative Breast CancerPhase 3NCT04613674

A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

A Phase 3 study testing Camrelizumab Plus Chemotherapy in people with Triple Negative Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC). Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Triple Negative Breast Cancer
What is being tested?: Camrelizumab Plus Chemotherapy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 441 participants
Where: 1 siteChina
Study dates: 9 Dec 2020to 5 Mar 2024
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 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

ECOG Performance Status of 0-1.
Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
Tumor stage: II-III.
Adequate hematologic and organ function.
Must be willing to use an adequate method of contraception for the course of the study.

Who cannot join

Has a history of breast cancer.
Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4].
Has a diagnosis of immunodeficiency or autoimmune diseases.
Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.

Show all 10Show fewer

Severe pulmonary or cardiac disease.
Known active hepatitis C virus, or known active hepatitis B virus.
History of organ or bone marrow transplantation.
Pregnant or breast-feeding women.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Cancer Hospital
Shanghai

Other trials in China

About this study

Official title: A Multicentre, Randomized, Double-blind, Parallel-controlled Phase Ⅲ Study to Evaluate Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Patients With Early or Locally Advanced Triple Negative Breast Cancer (TNBC).

Conditions: Triple Negative Breast Cancer
Being tested: Camrelizumab Plus Chemotherapy, placebo+chemotherapy
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 Plus ChemotherapyDrug
camrelizumab+chemotherapy
placebo+chemotherapyDrug
placebo+chemotherapy

Study groups in NCT04613674
Study group	Role	What they receive
Arm A	Experimental	Not described Receives: Drug: Camrelizumab Plus Chemotherapy
Arm B	Experimental	Not described Receives: Drug: placebo+chemotherapy

What is being measured

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

Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery.
Measured: Up to approximately 24 weeks

Secondary outcomes (5)

Event-free Survival (EFS) as assessed by Investigator.
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Measured: At least 2 years
Disease-free Survival (DFS) as assessed by Investigator
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause.
Measured: At least 2 years
Distant Disease-free Survival (DDFS) as assessed by Investigator
DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.
Measured: At least 2 years
Objective response rate (ORR) in accordance with RECIST v1.1
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.
Measured: Up to approximately 24 weeks
Percentage of Participants with Adverse Events (AEs)
Measured: Up to approximately 67 weeks

Timeline

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

9 Dec 20205 Mar 2024

First posted3 Nov 2020
Study start9 Dec 2020
Primary completion14 Sep 2023
Study completion5 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine 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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 441 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04613674
Sponsor's protocol ID: SHR1210-III-322
Status last verified: Mar 2024
First submitted: 29 Oct 2020
Last updated: 27 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen L, Li H, Zhang H, Yang H, Qian J, Li Z, Ren Y, Wang S, Fu P, Yang H, Liu Y, Sun J, Nie J, Lei R, Yao Y, Zhang A, Wang S, Ma X, Ouyang Z, Yang H, Wu SY, Cao SW, Wang K, Jiang A, Ouyang Q, Pang D, Wei L, Zha X, Shen Y, Qu X, Wu F, Zhu X, Wang Z, Fan L, Shao ZM. Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-Negative Breast Cancer: The CamRelief Randomized Clinical Trial. JAMA. 2025 Feb 25;333(8):673-681. doi: 10.1001/jama.2024.23560.
PubMed 39671272

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Randomized, Double-blind, Parallel-controlled Phase Ⅲ Study to Evaluate Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Patients With Early or Locally Advanced Triple Negative Breast Cancer (TNBC).
ClinicalTrials.gov ID: NCT04613674
Acronym / sponsor ID: SHR1210-III-322
Conditions: Triple Negative Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 441 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 9 Dec 2020 (actual)
Primary completion: 14 Sep 2023 (actual)
Study completion: 5 Mar 2024 (actual)
First posted: 3 Nov 2020 (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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Drug: Camrelizumab Plus Chemotherapy
Arm B	Experimental	Drug: placebo+chemotherapy

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

ECOG Performance Status of 0-1.
Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
Tumor stage: II-III.
Adequate hematologic and organ function.
Must be willing to use an adequate method of contraception for the course of the study.

Key exclusion criteria (10 listed)

Has a history of breast cancer.
Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4].
Has a diagnosis of immunodeficiency or autoimmune diseases.

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 Plus Chemotherapycamrelizumab+chemotherapy	Drug	Arm A
placebo+chemotherapyplacebo+chemotherapy	Drug	Arm B

Primary outcome

Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery.
Time frame: Up to approximately 24 weeks

5 secondary outcomes

Event-free Survival (EFS) as assessed by Investigator.
Time frame: At least 2 years
Disease-free Survival (DFS) as assessed by Investigator
Time frame: At least 2 years
Distant Disease-free Survival (DDFS) as assessed by Investigator
Time frame: At least 2 years
Objective response rate (ORR) in accordance with RECIST v1.1
Time frame: Up to approximately 24 weeks
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 67 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Derived from this study: PubMed 39671272Chen L, Li H, Zhang H, Yang H, Qian J, Li Z, Ren Y, Wang S, Fu P, Yang H, Liu Y, Sun J, Nie J, Lei R, Yao Y, Zhang A, Wang S, Ma X, Ouyang Z, Yang H, Wu SY, Cao SW, Wang K, Jiang A, Ouyang Q, Pang D, Wei L, Zha X, Shen Y, Qu X, Wu F, Zhu X, Wang Z, Fan L, Shao ZM. Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-Negative Breast Cancer: The CamRelief Randomized Clinical Trial. JAMA. 2025 Feb 25;333(8):673-681. doi: 10.1001/jama.2024.23560.
Individual participant dataSharing planned: No

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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?

A Phase 3 study testing Camrelizumab Plus Chemotherapy in people with Triple Negative Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

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 5 inclusion and 10 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: finished, as of the sponsor's last update on 27 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery. (time frame: Up to approximately 24 weeks). 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 NCT04613674, which also lists 1 linked publication.

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 27 Mar 2024.