Newly Diagnosed Triple-negative Breast CancerPhase 3CREATENCT07869628
A Multicenter, Randomized, Controlled Phase III Clinical Trial on Adjuvant Intensified Therapy for Patients With Residual Disease After Neoadjuvant Treatment for Triple-negative Breast Cancer
A Phase 3 study testing Capecitabine and PD-1 inhibitor, PD-1 inhibitor and Capecitabine in people with Newly Diagnosed Triple-negative Breast Cancer, run by Shandong Cancer Hospital and Institute.
Trial summary
This study is a multicenter, randomized controlled phase III clinical trial. The aim of this study is to observe the efficacy and safety of PD-1 inhibitors combined with capecitabine, PD-1 inhibitors alone, or capecitabine alone in patients with TNBC who have residual lesions after neoadjuvant treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Newly Diagnosed Triple-negative Breast Cancer
- What is being tested?
- Capecitabine and PD-1 inhibitor, PD-1 inhibitor and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2026to 31 Aug 2034
- Phase
- Phase 3
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before implementing any trial-related procedures, sign a written informed consent.
- Female, aged 18 years or above, and under 75 years old.
- ECOG PS 0-1.
- -
- Primary invasive breast cancer confirmed by initial pathology:
- Tumor stage: II-IIIc, without internal mammary lymph node and supraclavicular lymph node metastasis
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- HER2 negative: defined as IHC 0 or IHC 1+ or IHC 2+ and FISH -7 / 32
- Estrogen receptor (ER) and progesterone receptor (PR) negative: <1%.
- Received standard and complete course of neoadjuvant therapy (neoadjuvant chemotherapy + immunotherapy) as per the guidelines.
- After neoadjuvant treatment, received standard radical surgery and postoperative pathology indicated the presence of residual lesions (remaining invasive cancer foci in the breast and/or positive axillary lymph nodes), and the residual lesions were confirmed by immunohistochemistry to still be TNBC.
- Female patients with fertility must agree to use effective contraceptive methods during the study period and within 6 months after the last study medication.
- Pregnancy tests (urine or serum) for women of childbearing age must be negative .
- -
- The main organs function normally (within 14 days before enrollment), meeting the following criteria:
- The criteria for blood routine examination should be met (within 14 days before enrollment, no blood transfusion and no treatment with granulocyte colony-stimulating factor):
- Hemoglobin (HB) ≥ 90g/L;
- Neutrophils (ANC) ≥ 1.0×10^9/L;
- Platelets (PLT) ≥ 75×10^9/L;
- No organic functional diseases, meeting the following criteria:
- Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN (total bilirubin level > 1.5 ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;
- Alkaline phosphatase ALP, if greater than 2.5 X ULN, then the liver fraction should be ≤ 2.5 X ULN
- Serum creatinine level Cr ≤ 1.5xULN or calculated creatinine clearance rate (using MDRD formula) ≥ 40ml/min and Cr > 1.5xULN
- Urine protein < 2+, if the test strip ≥ 2+, then 24-hour urine protein must be < 2g, or urine albumin-to-creatinine ratio (UPC) must be < 2
- International normalized ratio (INR), activated partial thromboplastin time (aPTT): ≤ 1.5×ULN.
Who cannot join
- Stage IV metastatic breast cancer.
- Inflammatory breast cancer.
- Bilateral primary breast cancer (including invasive cancer and carcinoma in situ).
- New adjuvant therapy that has not completed the full course.
- Achieved pCR after neoadjuvant therapy.
- Previously received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured cases of cervical carcinoma in situ, skin basal cell carcinoma and squamous cell carcinoma.
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- Receiving any hormonal therapy (such as contraceptives, ovarian hormone replacement therapy, etc.), or any hormonal drugs (such as raloxifene, tamoxifen, or other selective estrogen receptor modulators) for the treatment of osteoporosis or breast cancer prevention.
- Within 4 weeks before randomization, underwent major surgical procedures unrelated to breast cancer or the patient has not fully recovered.
- Symptomatic peripheral neuropathy evaluated by CTCAE 5.0 grade ≥ 2.
- -
- Severe cardiovascular and cerebrovascular diseases, including but not limited to:
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- History of congestive heart failure or systolic dysfunction (LVEF < 50%);
- Angina pectoris requiring anti-anginal drugs;
- High-risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, etc.; average QTcF > 470ms during rest;
- Cardiac valve disease with cardiac dysfunction;
- Uncontrolled hypertension;
- History of myocardial infarction.
- Has had any allergy to any component of the drugs in this protocol.
- Not suitable for using corticosteroids.
- Has active infection and currently requires systemic anti-infection treatment.
- History of immunodeficiency, including positive HIV test, or having other acquired or congenital immune deficiency diseases, or having a history of organ transplantation.
- Participated in other intervention drug clinical trials within 28 days before randomization, or simultaneously participated in another clinical trial or used other investigational treatments.
- Pregnant (positive pregnancy test), lactating patients.
- Any other comorbid diseases that interfere with the implementation of the treatment plan, or the investigator believes that the subject has other serious systemic disease history, or other reasons that make it inappropriate to participate in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a multicenter, randomized controlled phase III clinical trial. The aim of this study is to observe the efficacy and safety of PD-1 inhibitors combined with capecitabine, PD-1 inhibitors alone, or capecitabine alone in patients with TNBC who have residual lesions after neoadjuvant treatment.
The subjects will be randomly assigned in a 1:1:1 ratio to Group A (capecitabine combined with PD-1 inhibitor), Group B (PD-1 inhibitor), and Group C (capecitabine). The stratification factors are the lymph node metastasis status (lymph node metastasis negative ypN0, lymph node metastasis positive ypN1-3) and PD-L1 status (negative/positive) after neoadjuvant treatment.
Read more
Group A: Capecitabine, 1250mg/m2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles Group B: PD-1 inhibitor, for a total of 8 cycles Group C: Capecitabine, 1250mg/m2, twice a day, 14/21 days, for a total of 8 cycles The study will include approximately 10 centers. After the completion of NAT (chemotherapy + immunotherapy), 852 patients with residual lesions (breast still has invasive cancer lesions remaining and/or positive axillary lymph nodes) will be enrolled, with 284 patients in each of Groups A, B, and C. After surgery, clinicians will, based on clinical treatment guidelines and the clinical practices of each center, administer radiotherapy to subjects with indications for radiotherapy.
During radiotherapy, the use of capecitabine and/or immunotherapy is decided by the supervising doctor as either concurrent or sequential.
- Being tested
- Capecitabine and PD-1 inhibitor, PD-1 inhibitor, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine and PD-1 inhibitorDrug
Group A: Capecitabine, 1250mg/m^2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles
PD-1 inhibitorDrug
Group B:PD-1 inhibitor, 8 treatment cycles in total
CapecitabineDrug
Group C:Capecitabine, 1250mg/m^2, twice a day, 14/21 days, a total of 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Group A (capecitabine and PD-1 inhibitor） Receives: Drug: Capecitabine and PD-1 inhibitor |
| B | Active comparator | Group B: PD-1 inhibitor Receives: Drug: PD-1 inhibitor |
| C | Active comparator | Group C: capecitabine Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The DFS (Disease-Free Survival) of patients randomly assigned to group A (capecitabine combined with PD-1 inhibitor), group B (PD-1 inhibitor) and group C (capecitabine) at the time of enrollment was compared
DFS was defined as the time from randomization to the first occurrence of any of the following events: 1) recurrence of breast cancer with ipsilateral chest wall and regional lymph node involvement; 2) distant metastasis (confirmed by histology or clinically diagnosed); 3) death related to breast cancer, unrelated to breast cancer, or with unknown cause; 4) recurrence of breast cancer on the opposite side.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start17 Oct 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2034 (estimated)
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 Newly Diagnosed Triple-negative 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tremelporant Injection
- Masking
- None (open label)
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pengfei Qiu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869628
- Sponsor's protocol ID
- ARISE-TNBC
- Acronym
- CREATE
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Phase III Clinical Trial on Adjuvant Intensified Therapy for Patients With Residual Disease After Neoadjuvant Treatment for Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07869628
- Acronym / sponsor ID
- CREATE / ARISE-TNBC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 17 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2034 (estimated)
- First posted
- 9 Oct 2026 (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.
This study is a multicenter, randomized controlled phase III clinical trial. The aim of this study is to observe the efficacy and safety of PD-1 inhibitors combined with capecitabine, PD-1 inhibitors alone, or capecitabine alone in patients with TNBC who have residual lesions after neoadjuvant treatment.
The subjects will be randomly assigned in a 1:1:1 ratio to Group A (capecitabine combined with PD-1 inhibitor), Group B (PD-1 inhibitor), and Group C (capecitabine). The stratification factors are the lymph node metastasis status (lymph node metastasis negative ypN0, lymph node metastasis positive ypN1-3) and PD-L1 status (negative/positive) after neoadjuvant treatment.
Group A: Capecitabine, 1250mg/m2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles Group B: PD-1 inhibitor, for a total of 8 cycles Group C: Capecitabine, 1250mg/m2, twice a day, 14/21 days, for a total of 8 cycles The study will include approximately 10 centers. After the completion of NAT (chemotherapy + immunotherapy), 852 patients with residual lesions (breast still has invasive cancer lesions remaining and/or positive axillary lymph nodes) will be enrolled, with 284 patients in each of Groups A, B, and C. After surgery, clinicians will, based on clinical treatment guidelines and the clinical practices of each center, administer radiotherapy to subjects with indications for radiotherapy.
During radiotherapy, the use of capecitabine and/or immunotherapy is decided by the supervising doctor as either concurrent or sequential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Tremelporant Injection
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Capecitabine and PD-1 inhibitorGroup A (capecitabine and PD-1 inhibitor） |
| B | Active comparator | Drug: PD-1 inhibitorGroup B: PD-1 inhibitor |
| C | Active comparator | Drug: CapecitabineGroup C: capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Before implementing any trial-related procedures, sign a written informed consent.
- Female, aged 18 years or above, and under 75 years old.
- ECOG PS 0-1.
- -
- Tumor stage: II-IIIc, without internal mammary lymph node and supraclavicular lymph node metastasis
Key exclusion criteria (25 listed)
- -
- <!-- -->
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 |
|---|---|---|
| Capecitabine and PD-1 inhibitorGroup A: Capecitabine, 1250mg/m^2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles | Drug | A |
| PD-1 inhibitorGroup B:PD-1 inhibitor, 8 treatment cycles in total | Drug | B |
| CapecitabineGroup C:Capecitabine, 1250mg/m^2, twice a day, 14/21 days, a total of 8 cycles | Drug | C |
Primary outcome
The DFS (Disease-Free Survival) of patients randomly assigned to group A (capecitabine combined with PD-1 inhibitor), group B (PD-1 inhibitor) and group C (capecitabine) at the time of enrollment was compared
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
DFS was defined as the time from randomization to the first occurrence of any of the following events: 1) recurrence of breast cancer with ipsilateral chest wall and regional lymph node involvement; 2) distant metastasis (confirmed by histology or clinically diagnosed); 3) death related to breast cancer, unrelated to breast cancer, or with unknown cause; 4) recurrence of breast cancer on the opposite side.
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 9 Oct 2026.
- Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine and PD-1 inhibitor, PD-1 inhibitor and Capecitabine in people with Newly Diagnosed Triple-negative Breast Cancer, run by Shandong Cancer Hospital and Institute.
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 25 inclusion and 25 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Pengfei Qiu (18615205204, qiupengfei2002@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The DFS (Disease-Free Survival) of patients randomly assigned to group A (capecitabine combined with PD-1 inhibitor), group B (PD-1 inhibitor) and group C (capecitabine) at the time of enrollment was compared (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.). 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 NCT07869628, 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 9 Oct 2026.