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

NCT07869628 | Not Yet Recruiting Phase 3

• 1 other identifier: ARISE-TNBC
• Study Type: interventional
• Target: 852
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Newly Diagnosed Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (3)

A

ACTIVE COMPARATOR

Group A (capecitabine and PD-1 inhibitor）

Drug: Capecitabine and PD-1 inhibitor

B

ACTIVE COMPARATOR

Group B: PD-1 inhibitor

Drug: PD-1 inhibitor

C

ACTIVE COMPARATOR

Group C: capecitabine

Drug: Capecitabine

Interventions

Capecitabine and PD-1 inhibitor DRUG

Group A: Capecitabine, 1250mg/m\^2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles

A

PD-1 inhibitor DRUG

Group B:PD-1 inhibitor, 8 treatment cycles in total

B

Capecitabine DRUG

Group C:Capecitabine, 1250mg/m\^2, twice a day, 14/21 days, a total of 8 cycles

C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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
• 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;

You may not qualify if:

• \- 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.
• 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;

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Related Publications (1)

• 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.

  PMID: 38572751 BACKGROUND

MeSH Terms

Interventions

Capecitabine; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Pengfei Qiu

CONTACT

18615205204; qiupengfei2002@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Tremelporant Injection

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 17, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2034
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share