A Phase 3 interventional study of Capecitabine and PD-1 inhibitor and PD-1 inhibitor in Newly Diagnosed Triple-negative Breast Cancer, sponsored by Shandong Cancer Hospital and Institute. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Shandong Cancer Hospital and Institute · Phase 3, Interventional, and Treatment
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.
Shandong Cancer Hospital and Institute is the lead sponsor of 105 studies on the registry; 38 are open to participants now.
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- 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.
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Primary invasive breast cancer confirmed by initial pathology:
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 .
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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):
No organic functional diseases, meeting the following criteria:
Exclusion Criteria:
- 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.
- 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.
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Severe cardiovascular and cerebrovascular diseases, including but not limited to:
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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.
Group A (capecitabine and PD-1 inhibitor）
Drug: Capecitabine and PD-1 inhibitor
Group B: PD-1 inhibitor
Drug: PD-1 inhibitor
Group C: capecitabine
Drug: Capecitabine
Drug page: Capecitabine
Group A: Capecitabine, 1250mg/m\^2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles
Group B:PD-1 inhibitor, 8 treatment cycles in total
Group C:Capecitabine, 1250mg/m\^2, twice a day, 14/21 days, a total of 8 cycles
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.
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.
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Start is estimated for Oct 2026; primary completion for Aug 2029, 34 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Capecitabine
Shandong Cancer Hospital and Institute →