Breast CancerPhase 2NCT05475678
Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer
A Phase 2 study testing （Carrelizumab + TCb） regimen and TCb regimen in people with Breast Cancer and Triple Negative Breast Cancer, run by Zhenzhen Liu at 1 site in China.
Trial summary
Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer, Camrelizumab
- What is being tested?
- （Carrelizumab + TCb） regimen and TCb regimen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age: 18-70 years old
- cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
- Pathologically proven triple negative breast cancer:
- Triple-negative breast cancer is defined as:
- Negative for ER and PR (IHC nuclear staining <10%)
- Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
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- Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
- Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
- Cardiac ultrasound EF value ≧55%；
- Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
- ECOG score≤1 point;
- Sign informed consent；
Who cannot join
- The patient has evidence of metastatic breast cancer；
- For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
- The patient has a second primary malignancy other than adequately treated skin cancer;
- The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
- The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
- The patient has severe lung or heart disease;
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- The patient has active hepatitis B and C;
- The patient has a history of organ transplantation or bone marrow transplantation;
- pregnant or breastfeeding women;
- The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou, Henan
Zhen Liu, 18603723729
About this study
Official title: A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer
Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored.
Camrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety.
Therefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.
Read the detailed description
This study mainly compared the efficacy and safety of 6*TCb (docetaxel+carboplatin)+carrelizumab regimen and 6*TCb regimen in neoadjuvant chemotherapy for triple-negative breast cancer.
Patients who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 2:1 ratio.
- The experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle.
- The control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle.
The efficacy and safety of the two chemotherapy regimens on neoadjuvant chemotherapy for triple-negative breast cancer were evaluated by PCR, EFS, DFS, DDFS and ORR after surgery.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, Camrelizumab
- Being tested
- （Carrelizumab + TCb） regimen, TCb regimen
- Keywords
- Triple Negative Breast Cancer, Camrelizumab, Neoadjuvant chemotherapy, Pathological complete response rate, Disease-free survival
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
（Carrelizumab + TCb） regimenDrug
Also called Carrelizumab +docetaxel + carboplatin
Carrelizumab +docetaxel + carboplatin regimen
TCb regimenDrug
Also called docetaxel + carboplatin
docetaxel + carboplatin regimen
| Study group | Role | What they receive |
|---|---|---|
| （Carrelizumab + TCb） regimen | Experimental | The experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle. Receives: Drug: （Carrelizumab + TCb） regimen |
| TCb regimen | Placebo comparator | The control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle. Receives: Drug: TCb regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR rate)
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
Measured: up to 24 weeks
Secondary outcomes (5)
Event-Free Survival (EFS)
EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause.
Measured: 5-10 years after surgery.
DFS
Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Measured: 5-10 years after surgery
Distant Disease Free Survival (DDFS)
DDFS is defined as the time from surgery to distant recurrence or death from any cause
Measured: 5-10 years after surgery
Objective Response Rate (ORR)
ORR is defined as the number of target lesion responders as assessed by MRI
Measured: Preoperative
number of adverse events
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Measured: After each cycle of chemotherapy (21 days as 1 cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start20 Dec 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The enrolled patients were randomly assigned to the experimental group and the control group in a ratio of 2:1.
- Masking
- None (open label)
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenzhen Liu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475678
- Sponsor's protocol ID
- HELEN-011
- Status last verified
- Jan 2025
- First submitted
- 19 Jul 2022
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05475678
- Acronym / sponsor ID
- HELEN-011
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, Camrelizumab
- Keywords
- Triple Negative Breast Cancer, Camrelizumab, Neoadjuvant chemotherapy, Pathological complete response rate, Disease-free survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Zhenzhen LiuOther government
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Jul 2022 (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.
Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored.
Camrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety.
Therefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.
Detailed description
This study mainly compared the efficacy and safety of 6*TCb (docetaxel+carboplatin)+carrelizumab regimen and 6*TCb regimen in neoadjuvant chemotherapy for triple-negative breast cancer.
Patients who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 2:1 ratio.
- The experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle.
- The control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle.
The efficacy and safety of the two chemotherapy regimens on neoadjuvant chemotherapy for triple-negative breast cancer were evaluated by PCR, EFS, DFS, DDFS and ORR after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The enrolled patients were randomly assigned to the experimental group and the control group in a ratio of 2:1.
| Arm | Type | Receives |
|---|---|---|
| （Carrelizumab + TCb） regimen | Experimental | Drug: （Carrelizumab + TCb） regimenThe experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle. |
| TCb regimen | Placebo comparator | Drug: TCb regimenThe control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 18-70 years old
- cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
- Pathologically proven triple negative breast cancer:
- Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
- Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
Key exclusion criteria (10 listed)
- The patient has evidence of metastatic breast cancer；
- For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
- The patient has a second primary malignancy other than adequately treated skin cancer;
- The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
- The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
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 |
|---|---|---|
| （Carrelizumab + TCb） regimenAlso: Carrelizumab +docetaxel + carboplatinCarrelizumab +docetaxel + carboplatin regimen | Drug | （Carrelizumab + TCb） regimen |
| TCb regimenAlso: docetaxel + carboplatindocetaxel + carboplatin regimen | Drug | TCb regimen |
Primary outcome
Pathological complete response rate (pCR rate)
Time frame: up to 24 weeks
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
5 secondary outcomes
Event-Free Survival (EFS)
Time frame: 5-10 years after surgery.
DFS
Time frame: 5-10 years after surgery
Distant Disease Free Survival (DDFS)
Time frame: 5-10 years after surgery
Objective Response Rate (ORR)
Time frame: Preoperative
number of adverse events
Time frame: After each cycle of chemotherapy (21 days as 1 cycle)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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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.
Zhenzhen Liu principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing （Carrelizumab + TCb） regimen and TCb regimen in people with Breast Cancer and Triple Negative Breast Cancer, run by Zhenzhen Liu 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 12 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: looking for participants now, as of the sponsor's last update on 23 Jan 2025. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Liu (13603862755, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR rate) (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2025.