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New treatment option for Breast Neoplasms
Official title Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy
ClinicalTrials.gov ID: NCT06313463
What this study is testing
What is Carrellizumab + Capecitabine?
Carrellizumab + Capecitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy and have tertiary lymphoid structures (TLS) in the tumor tissue. The primary endpoint of this study is disease-free survival (DFS) to assess the long-term effectiveness of the treatment.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- Signed informed consent form.
- Female patients aged ≥18 years at the time of signing informed consent.
- Patients with adequate cognitive ability and willingness to understand and comply with the treatment and follow-up plans as required by the study...
- Confirmed invasive breast cancer on histological examination.
- Clinical stage at presentation: cT4/any N/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (patients with cT1mi/T1a/T1b/N0 are not eligible).
You likely can't join if
- Stage IV (metastatic) breast cancer
- Inadequate resection (as described in the inclusion criteria)
- At the end of preoperative systemic therapy, the overall response assessment by the researchers resulted in disease progression.
- Patients recommended for radiotherapy for breast cancer but contraindicated due to medical reasons (e.g., connective tissue diseases or prior...
- Presence of another malignant tumor within the last 5 years before screening (excluding appropriately treated cervical carcinoma in situ...
- Prior use of CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T-lymphocyte-associated protein 4, anti-PD-1, and anti-PD-L1...
See the full eligibility criteria
Who can join
- Signed informed consent form.
- Female patients aged ≥18 years at the time of signing informed consent.
- Patients with adequate cognitive ability and willingness to understand and comply with the treatment and follow-up plans as required by the study protocol.
- Confirmed invasive breast cancer on histological examination.
- Clinical stage at presentation: cT4/any N/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (patients with cT1mi/T1a/T1b/N0 are not eligible).
- Confirmation of TNBC diagnosis and TLS and PD-L1 status through central examination of representative tumor tissue specimens resected during surgery.
- Patients with synchronous bilateral invasive disease or multicentric tumors (involving more than one quadrant) are eligible for the study, provided that all discrete lesions are confirmed by the central laboratory as...
- For patients with multifocal or multicentric breast cancer, measurement of the largest lesion to determine the T stage is required.
- Confirmation of TNBC and prospective assessment of TLS presence in tumor tissue before study enrollment, confirmed by HE staining and immunofluorescence staining. TLS positivity is defined as the presence of CD3+ and...
- Completion of preoperative systemic chemotherapy and camrelizumab treatment.
- Pathological assessment after neoadjuvant treatment did not achieve pCR.
- Adequate resection: Complete removal of all clinically evident lesions in the breast and lymph nodes.
- Interval between the date of initial surgery and randomization date not exceeding 12 weeks.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Completion of neoadjuvant therapy with echocardiography or multi-gated acquisition scan showing left ventricular ejection fraction (LVEF) ≥50% during the screening period and an absolute decrease in LVEF compared to...
- Life expectancy ≥6 months.
- Adequate hematological and organ function.
- Negative HIV test result during screening, with the following exceptions: patients with positive HIV test results during screening are eligible to participate in the study, provided they receive stable antiretroviral...
- Negative hepatitis B surface antigen (HBsAg) test result during screening.
- Negative hepatitis C virus (HCV) antibody test result during screening, or positive HCV antibody test result during screening, followed by negative HCV RNA test result.
- For women of childbearing potential: agreement to practice abstinence (no heterosexual intercourse) or use contraception, and agreement not to donate eggs.
What rules you out
- Stage IV (metastatic) breast cancer
- Inadequate resection (as described in the inclusion criteria)
- At the end of preoperative systemic therapy, the overall response assessment by the researchers resulted in disease progression.
- Patients recommended for radiotherapy for breast cancer but contraindicated due to medical reasons (e.g., connective tissue diseases or prior radiation to the ipsilateral breast).
- Presence of another malignant tumor within the last 5 years before screening (excluding appropriately treated cervical carcinoma in situ, non-melanoma skin cancer, Stage I endometrial carcinoma, or DCIS).
- Prior use of CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T-lymphocyte-associated protein 4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
- Current presence of ≥ Grade 2 peripheral neuropathy (according to NCI CTCAE v5.0).
- Dyspnea at rest.
- Presence of any of cardiopulmonary dysfunction.
- Current or past history of autoimmune disease or immunodeficiency.
- Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or history of idiopathic pneumonia or evidence of active pneumonia.
- Active tuberculosis.
- History of severe, uncontrolled systemic diseases (e.g., clinically significant cardiovascular, pulmonary, or metabolic diseases; impaired wound healing; ulcers).
- Known active liver disease, such as autoimmune hepatitis or sclerosing cholangitis.
- Receipt of major surgery within 4 weeks before randomization (excluding breast cancer surgery) or anticipated need for major surgery during the study.
- Occurrence of severe infection within 4 weeks before randomization, including but not limited to hospitalization due to complications of infection, sepsis, or severe pneumonia, SARS-CoV-2 infection, or any active...
- Receipt of therapeutic antibiotics by intravenous injection within 2 weeks or oral antibiotics within 5 days before randomization.
- Previous allogeneic bone marrow or solid organ transplantation.
- Contraindication to experimental drugs or any other diseases, metabolic disorders, physical examination findings, or clinical laboratory findings that may affect the interpretation of results or may put the patient at...
- Receipt of a live attenuated vaccine within 4 weeks before randomization or anticipated need for such a vaccine during the study treatment period or within 5 months after the last dose of treatment.
- Receipt of experimental treatment within 28 days before randomization.
- Receipt of systemic immunostimulatory agents (including but not limited to interferons and IL-2) within 4 weeks before randomization or within 5 half-lives of the drug (whichever is longer).
- Receipt of systemic immunosuppressive medications (including but not limited to corticosteroids, azathioprine, methotrexate, salicylates, and anti-tumor necrosis factor-alpha [TNF-α] agents) within 2 weeks before...
- Previous severe hypersensitivity/allergic reaction to chimeric or humanized antibodies or fusion proteins.
- Known severe hypersensitivity to any component of the drug.
- Pregnancy or lactation, or planning to become pregnant within 6 months after the end of the study treatment period.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.