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Compares treatment options for TNBC - Triple-Negative Breast Cancer
Official title A Multi-center, Randomized, Open-label, Phase III Study Comparing PD-1 Inhibitor Combined With Antivascular Therapy and Anthracycline/Taxane-based Adjuvant Chemotherapy Versus Anthracycline/Taxane-based Adjuvant Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT05862064
What this study is testing
What is epirubicin,cyclophosphamide,paclitaxel,Carrelizumab?
epirubicin,cyclophosphamide,paclitaxel,Carrelizumab is an investigational medicine, being studied as a potential treatment for tnbc - triple-negative breast cancer.
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 review will evaluate the efficacy and safety of SHR1210 (Camrelizumab) and antivascular drug(Famitinib) in combination with anthracyclines/taxane-based adjuvant chemotherapy (carrelizumab + FAM + EC-P) compared with conventional chemotherapy regimens (dose-intensive epirubicin and cyclophosphamide, sequential paclitaxel, or EC-P) in patients with early-stage high-risk TNBC.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 70, women only
You may be able to join if
- Sign the Informed Consent Form (ICF)
- The patient is judged by the investigator to have the ability to comply with the provisions of the protocol
- Women aged 18\~70 at the time of signing the ICF
- Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1
- Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0
You likely can't join if
- Have a history of invasive breast cancer
- T4 clinical tumors as specified in the UICC/AJCC Tumor-Lymph Node Metastasis Classification (8th Edition), including inflammatory breast cancer
- For currently diagnosed breast cancer, prior systemic anticancer therapy (eg, neoadjuvant therapy or adjuvant therapy) includes, but is not limited...
- Previous treatment with anthracyclines or taxane for any malignant tumor
- History of DCIS and/or LCIS, treatment of ipsilateral breast cancer with systemic therapy, hormone therapy, or RT, followed by invasive cancer...
- Prior to randomization, cardiopulmonary dysfunction according to any of the following: history of NCI CTCAE v4.0 ≥3 symptomatic congestive heart...
See the full eligibility criteria
- Sign the Informed Consent Form (ICF)
- The patient is judged by the investigator to have the ability to comply with the provisions of the protocol
- Women aged 18\~70 at the time of signing the ICF
- Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1
- Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0
- Histological results recorded as TNBC (negative HER2, ER and PgR status)
- Adequate excision: Patients must have undergone breast-conserving or mastectomy/nipple-sparing mastectomy.
- Pathological tumor-lymph node metastasis staging (IUCC/Joint American Committee on Cancer [UICC/AJCC], 8th edition): Patients undergoing pathologic lymph node status assessment must undergo sentinel lymph node biopsy...
- Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500...
- For women of childbearing age: agree to remain abstinent (avoid heterosexual intercourse) or take an annual failure rate for at least 5 months during treatment and at least 5 months after the last dose of SHR1210...
- Have the willingness and ability to follow scheduled visits, treatment protocols, laboratory tests and other research procedures
- Have a history of invasive breast cancer
- T4 clinical tumors as specified in the UICC/AJCC Tumor-Lymph Node Metastasis Classification (8th Edition), including inflammatory breast cancer
- For currently diagnosed breast cancer, prior systemic anticancer therapy (eg, neoadjuvant therapy or adjuvant therapy) includes, but is not limited to, chemotherapy, anti-HER2 therapy (eg, trastuzumab emtansine...
- Previous treatment with anthracyclines or taxane for any malignant tumor
- History of DCIS and/or LCIS, treatment of ipsilateral breast cancer with systemic therapy, hormone therapy, or RT, followed by invasive cancer, patients treated with DCIS/LCIS only surgery and/or RT for contralateral...
- Prior to randomization, cardiopulmonary dysfunction according to any of the following: history of NCI CTCAE v4.0 ≥3 symptomatic congestive heart failure or New York College of Cardiology (NYHA) standard classification≥...
- Prior malignancy within 5 years prior to randomization, with negligible risk of metastasis or death, except for malignancy that is expected to heal after treatment (i.e., appropriately treated carcinoma in situ or basal...
- Have a history of severe allergic reactions, allergic reactions or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; Hypersensitivity to biopharmaceutical products produced by...
- Have a history of active or previous autoimmune disease or immunodeficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis...
- History of idiopathic pulmonary fibrosis, organic pneumonia (eg, bronchiolitis obliterans), drug-based. Patients with a history of radiation pneumonia (fibrosis) in the field where evidence of active pneumonia is...
- Obstruction of urination
- Active tuberculosis
- Patients with serious infections (including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia) that occurred within 4 weeks prior to initiation of study treatment, who...
- Significant surgery within 4 weeks prior to study treatment initiation other than diagnosis, or expected to undergo major surgery during study treatment or within 5 months of last SHR1210 (carrelizumab) or famitinib...
- Have undergone allogeneic stem cell or solid organ transplantation
- Have received live attenuated vaccine within 4 weeks prior to initiation of study treatment, or expected to be required during the study or within 5 months of the last dose of SHR1210 (carrelizumab). Patients must agree...
- Previous CD137 agonist or immune checkpoint blocking therapy, including anti-CD40, anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibody therapy
- Received systemic immunostimulant therapy (including but not limited to interferon, interleukin-2) within 4 weeks prior to initiation of study treatment or 5 times the half-life of the drug (whichever is longer)
- Systemic immunosuppressive drugs (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] α drugs) within 2 weeks prior to study...
- Pregnant or lactating women, or women planning to become pregnant during the study period
- Poorly controlled hypertension (defined as: systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \>100 mmHg)
- Bleeding, thrombotic illness, or use of an anticoagulant (e.g., warfarin) or similar drug requiring therapeutic INR monitoring within 6 months prior to the first administration of the study drug
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.