Actively Recruiting
PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC
Led by Guangdong Provincial People's Hospital · Updated on 2024-11-04
310
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 the classification according to their BRCA mutation status, patients with BRCA mutations choose the PD-1 inhibitor + PARPi regimen, while patients without BRCA mutations opt for the PD-1 inhibitor + capecitabine regimen. Compared to monotherapy with PD-1 inhibitors, these combination regimens may offer improved efficacy and acceptable tolerability. This study is designed as a prospective, randomized, controlled, open-label, single-center phase III trial aimed at assessing the efficacy and safety of selecting PARPi or capecitabine in combination with PD-1 inhibitors based on germline BRCA1/2 mutations as adjuvant therapy in high-risk TNBC patients who have achieved non-pCR after completion of neoadjuvant immunotherapy in conjunction with chemotherapy and local treatment.
CONDITIONS
Official Title
PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed invasive breast cancer
- Negative estrogen receptor and progesterone receptor expression by immunohistochemistry
- Negative HER2 status confirmed by immunohistochemistry and in situ hybridization when needed
- Clinical tumor staging of T1c, N1-N2 or T2, N0-N2 or T3, N0-N2 or T4a-d, N0-N2
- Good organ function confirmed by blood tests within 7 days before randomization:
- Hemoglobin 6 g/L or higher
- Absolute neutrophil count 1.5 x 10^9/L or higher
- Absolute lymphocyte count 0.5 x 10^9/L or higher
- Platelet count 100 x 10^9/L or higher
- White blood cell count between 3.0 and 15 x 10^9/L
- Liver enzymes ALT and AST less than or equal to 1.5 times the upper limit of normal
- Alkaline phosphatase less than or equal to 2.5 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- Serum creatinine less than or equal to 1.5 times the upper limit of normal and creatinine clearance at least 50 mL/min
- Prothrombin time, activated partial thromboplastin time, and INR less than or equal to 1.5 times the upper limit of normal if not on anticoagulants
- Normal thyroid-stimulating hormone levels or normal thyroid hormone levels if TSH is abnormal
- Urinary protein less than 2+ or 24-hour urine protein less than or equal to 1g if proteinuria is higher
- Left ventricular ejection fraction at least 55%
- QT interval corrected for heart rate less than 470 milliseconds
- Negative pregnancy test within 3 days before starting medication for women of childbearing potential
- Agreement to use highly effective contraception during the study and for 180 days after last drug administration
- Voluntary participation and signed informed consent
You will not qualify if you...
- Known allergy to components of the investigational drug
- Previous antitumor treatment or radiation for any malignancy except cured cervical carcinoma in situ or basal cell carcinoma
- Major surgery unrelated to breast cancer within the past 4 weeks or not fully recovered from such surgery
- Difficulty swallowing, intestinal obstruction, or other issues affecting medication absorption
- Severe heart disease or discomfort preventing treatment
- Mental illness or substance abuse affecting study compliance
- Pregnant or breastfeeding
- Participation in other clinical trials
- Any condition posing serious risk or affecting study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
L
Liulu Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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