Status:
RECRUITING
PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Triple-negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
In TNBC patients who have completed neoadjuvant immunotherapy and local treatment, a 9-cycle regimen of PD-1 inhibitor adjuvant immunotherapy is currently considered the standard approach. Based on th...
Eligibility Criteria
Inclusion
- Pathologically confirmed invasive breast cancer.
- Negative expression of estrogen receptor (ER) and progesterone receptor (PR) according to immunohistochemistry (i.e., tumor cells showing positive staining in less than 1% of all tumor cells).
- Negative human epidermal growth factor receptor 2 (HER2) status as determined by immunohistochemistry: HER2 score of 0/1+ or, if the score is 2+, HER2/CEP17 ratio less than 2.0 or HER2 gene copy number less than 4, as confirmed by in situ hybridization (ISH).
- Clinical tumor staging: T1c, N1-N2 or T2, N0-N2 or T3, N0-N2 or T4a-d, N0-N2.
- The subjects were required to have good organ function, as evidenced by the following tests conducted within 7 days before randomization:
- Hematology examination (excluding blood transfusion or use of hematopoietic stimulating agents for correction):
- Hemoglobin (Hb) ≥ 90 g/L.
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
- Absolute lymphocyte count (ALC) ≥ 0.5 × 109/L.
- Platelet count (PLT) ≥ 100 × 109/L.
- White blood cell count (WBC) ≥ 3.0 × 109/L and ≤ 15 × 109/L.
- Serum biochemistry examination (excluding recent blood transfusion or albumin administration):
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN).
- Alkaline phosphatase (ALP) ≤ 2.5 ULN.
- Total bilirubin (TBIL) ≤ 1.5 ULN.
- Serum creatinine (Cr) ≤ 1.5 ULN, with creatinine clearance (CrCL) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula).
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN, and international normalized ratio (INR) ≤ 1.5 ULN (if not receiving anticoagulant therapy).
- Thyroid-stimulating hormone (TSH) within the normal range; if TSH is abnormal, levels of free triiodothyronine (FT3) and free thyroxine (FT4) should be examined. If FT3/FT4 results are not available, T3 and T4 measurements can be considered, and if T3/T4 levels are within the normal range, the subject can be included.
- Urine analysis: Urinary protein \< 2+; if urinary protein is ≥ 2+, a 24-hour urine protein quantification should demonstrate protein ≤ 1g.
- Cardiac echocardiography: Left ventricular ejection fraction (LVEF) ≥ 55%.
- 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \< 470 msec.
- Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiating medication, and they and their partners must agree to use highly effective methods of contraception during the study and for 180 days after the last administration of the investigational drug.
- Voluntary participation in the clinical trial and signing of the informed consent form are required.
Exclusion
- Known history of allergy to the components of the investigational drug.
- Previous receipt of antitumor treatment or radiation therapy for any malignancy (excluding previously cured cervical carcinoma in situ and basal cell carcinoma).
- Undergone major surgery unrelated to breast cancer within the past 4 weeks, or patients who have not fully recovered from such surgery.
- Inability to swallow, intestinal obstruction, or other factors that may affect the administration and absorption of the medication.
- Severe cardiac disease or discomfort that prevents treatment.
- Presence of mental illness or substance abuse that interferes with compliance.
- Pregnant or breastfeeding women.
- Concurrent participation in other clinical trials.
- Subjects deemed by the investigator to have conditions that pose a serious risk to the safety of the participant or may affect the completion of the study, or individuals who are considered unsuitable for inclusion based on other reasons.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06533384
Start Date
August 1 2024
End Date
December 31 2030
Last Update
November 4 2024
Active Locations (1)
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1
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
Guangzhou, Guangdong, China, 510080