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New treatment option for Triple-negative Breast Cancer
Official title PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC
ClinicalTrials.gov ID: NCT06533384
What this study is testing
What is As per the germline BRCA1/2 mutation status, the selection of either Fuzuloparib or capecitabine in combination with Camrelizumab is made for adjuvant therapy.?
As per the germline BRCA1/2 mutation status, the selection of either Fuzuloparib or capecitabine in combination with Camrelizumab is made for adjuvant therapy. is an investigational medicine, being studied as a potential treatment for 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
- 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.
- 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
- Pathologically confirmed invasive breast cancer.
- Negative expression of estrogen receptor (ER) and progesterone receptor (PR) according to immunohistochemistry (i.e., tumor cells showing positive...
- Negative human epidermal growth factor receptor 2 (HER2) status as determined by immunohistochemistry: HER2 score of 0/1+ or, if the score is 2+...
- Clinical tumor staging: T1c, N1-N2 or T2, N0-N2 or T3, N0-N2 or T4a-d, N0-N2.
- The people were required to have good organ function, as evidenced by the following tests conducted within 7 days before randomization: Hematology...
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- Clinical tumor staging: T1c, N1-N2 or T2, N0-N2 or T3, N0-N2 or T4a-d, N0-N2.
- The people 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...
- 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...
- 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...
- Voluntary participation in the clinical trial and signing of the informed consent form are required.
- 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.
- people 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...
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 70 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.