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

NCT05862064 | Recruiting Phase 3

• 1 other identifier: BCTOP-T-A02
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TNBC - Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• iDFS

  invasive disease-free survival

  5 years

Secondary Outcomes (2)

• DDFS

  5 years

• OS

  5 years

Study Arms (2)

Arm-A

EXPERIMENTAL

SHR1210 (carrelizumab): 200 mg in combination with chemotherapy (described below) intravenously (IV), Q2W, and famitinib (10 mg) orally once daily (QD). This was followed by maintenance therapy with SHR1210 (carrelizumab) (200 mg, IV every 2 weeks \[Q2W\]) and famitinib (10 mg) orally once daily (QD) to complete treatment with a total duration of 1 year from the first dose. Chemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q2W for a total of 4 doses, followed by (IV) paclitaxel（80 mg/m2）or albumin-paclitaxel(100 mg/m2) once weekly (QW) for 12 weeks.

Drug: epirubicin,cyclophosphamide,paclitaxel,Carrelizumab

Arm-B

SHAM COMPARATOR

Chemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q2W for a total of 4 doses, followed by (IV) paclitaxel（80 mg/m2）or albumin-paclitaxel(100 mg/m2) once weekly (QW) for 12 weeks.

Drug: epirubicin,cyclophosphamide,paclitaxel

Interventions

epirubicin,cyclophosphamide,paclitaxel,Carrelizumab DRUG

Conventional chemotherapy in combination with carrelizumab

Arm-A

epirubicin,cyclophosphamide,paclitaxel DRUG

Conventional chemotherapy

Arm-B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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 (SLNB) and/or axillary lymph node dissection. As mentioned above, patients with simultaneous bilateral invasive disease are eligible only if all bilateral invasive lesions are confirmed by histological examination by the central laboratory as triple-negative lesions and bilateral pathopathological-lymph node metastasis staging has been completed. The interval between final breast cancer surgery (or the last surgery for cure if additional resection of breast cancer is required) and randomization should not exceed 8 weeks (56 days).
• 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 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Lymphocyte count≥ 500 cells/μL; Platelet count≥ 100,000 cells/μL (no platelet transfusion within 2 weeks before day 1 of course 1; hemoglobin≥ 9.0 g/dL; AST, ALT, and alkaline phosphatase≤ 2.5 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; Patients with known Gilbert disease and serum bilirubin levels ≤ 3× ULN may be admitted; For patients not receiving anticoagulant therapy: INR or aPTT ≤ 1.5 × ULN within 28 days prior to initiation of study therapy; For patients receiving anticoagulant therapy: a stable anticoagulant regimen within 28 days before the start of study therapy and a stable INR; creatinine clearance≥ 30 mL/min (calculated using the Cockcroft-Gault formula); Serum albumin ≥ 2.5 g/dL
• 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 (carrelizumab), or 6 months after the last dose of paclitaxel or doxorubicin, or 12 months after the last dose of cyclophosphamide, whichever occurs last \< 1% of contraception. A woman who is postmenopausal but has not yet reached postmenopausal status (menopause lasts ≥for 12 consecutive months, for no reason other than menopause) and has not undergone sterilization (ovarian and/or hysterectomy) is considered fertile.
• Have the willingness and ability to follow scheduled visits, treatment protocols, laboratory tests and other research procedures

You may not qualify 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 to, chemotherapy, anti-HER2 therapy (eg, trastuzumab emtansine, pertuzumab, lapatinib, neratinib or other tyrosine kinase inhibitors), hormone therapy, or anti-cancer RT, except for treatments planned under this study condition
• 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 DCIS may be enrolled in the study.
• 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≥ II, angina requiring antianginal drugs, severe arrhythmias not treated with appropriate medical therapy, severe conduction abnormalities, or clinically significant valvular disease, high-risk, uncontrolled arrhythmias (i.e., atrial tachycardia with \> resting rate). 100/min, significant ventricular arrhythmia \[ventricular tachycardia\], or high-grade atrioventricular \[AV\] block \[second-degree AV block type 2, or third-degree atrioventricular block\]), significant symptoms associated with left ventricular dysfunction, arrhythmia, or myocardial ischemia (grade ≥2), myocardial infarction within 12 hours prior to randomization; with uncontrolled hypertension (systolic blood pressure\> 180 mmHg and/or diastolic blood pressure \> 100 mmHg; ECG findings show transmural infarction; Oxygen therapy is required
• 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 or squamous cell skin cancer).
• 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 Chinese hamster ovary cells is known; Known allergic or hypersensitivity to any component of the SHR1210 (carrelizumab) preparation; known allergic or hypersensitivity to any component of paclitaxel (eg, polyoxyethylene 35 castor oil), cyclophosphamide, or doxorubicin/epirubicin preparations; Allergic or hypersensitivity reactions are known to filgrastine, pefistim, or GM-CSF preparations
• 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, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, except in patients with a history of autoimmune-related hypothyroidism, if receiving a stable dose of thyroid hormone replacement therapy, Participation in this study is available. People with type 1 diabetes who have controlled blood glucose on insulin dosing regimens may participate in this study. Patients with eczema, psoriasis, chronic lichen simplex, or vitiligo who present only with skin conditions (eg, patients with psoriatic arthritis should be excluded) are allowed to participate in this study, provided that all of the following criteria are met: the body surface area covered by the rash should be met \<10%。 Disease is adequately controlled at baseline and only topical low-potency corticosteroid therapy is required. There has been no acute exacerbation of the underlying disease in the past 12 months and does not require treatment with psoralen + UV A irradiation, methotrexate, retinoids, biologics, oral calcineurin inhibitors, and highly active or oral glucocorticoids
• 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 detected on screening by chest computed tomography (CT) may participate in this study.
• 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 received therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment, and who received prophylactic antibiotic therapy (such as prophylaxis for urinary tract infection or prevention of chronic obstructive pulmonary disease) may be enrolled.
• 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 (for patients randomized to SHR1210 (carrelizumab)).
• Have undergone allogeneic stem cell or solid organ transplantation

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Epirubicin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Zhimin Shao, MD,PhD

CONTACT

+86-021-64175590; zhimingshao@yahoo.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: Director of General Surgery of Fudan Shanghai Cancer Center

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 17, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

CN (1)