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New treatment option for Triple-negative Breast Cancer
Official title Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC
ClinicalTrials.gov ID: NCT06817525
What this study is testing
What is 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1)?
6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1) is an investigational medicine, being studied as a potential treatment for triple-negative breast cancer.
Also referred to as 6*Albumin-bound paclitaxe (d 1)+6*Carboplatin ( d 1)+6*Camrelizumab (d 1).
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
- We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.
- Phase 2: a mid-size study of how well it works
- 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 65, women only
You may be able to join if
- Age: 18-65 years old;
- Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis;
- Three negative type and invasive breast cancer confirmed by histopathology; Three negative breast cancer is defined as:
- ER and PR negative (IHC nuclear staining\<10%)
- Her-2 negative (IHC 0, 1+without FISH, or IHC 2+without FISH amplification)
You likely can't join if
- There is evidence of metastatic breast cancer (in order to exclude metastatic breast cancer, chest and abdomen CT and bone scanning should be...
- Have Received chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. for this disease;
- The patient has a second primary malignant tumor, in addition to: fully treated skin cancer;
- Received treatment with anti-PD-1, anti-PDL1, anti-PD-L2 drugs, or other immunotherapy;
- Diagnosed with immunodeficiency or autoimmune diseases;
- Severe lung or heart disease;
See the full eligibility criteria
- Age: 18-65 years old;
- Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis;
- Three negative type and invasive breast cancer confirmed by histopathology; Three negative breast cancer is defined as:
- ER and PR negative (IHC nuclear staining\<10%)
- Her-2 negative (IHC 0, 1+without FISH, or IHC 2+without FISH amplification)
- Clinically measurable lesions: Measurable lesions displayed by ultrasound, mammography, or MR (optional) within one month prior to screening;
- Organ and bone marrow function tests within 2 weeks before chemotherapy indicate no contraindications for chemotherapy:
- Absolute value of neutrophil count ≥ 2.0 × 109/L
- Hemoglobin ≥ 100g/L
- Platelet count ≥ 100 × 109/L
- Total bilirubin\<1.5 ULN (upper limit of normal)
- Creatinine\<1.5 × ULN
- AST/ALT \< 1.5×ULN；
- Thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); If there are abnormalities, T3 and T4 levels should be examined. If T3 and T4 levels are normal, they can be selected
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN, while meeting international standards Normalization ratio (INR) ≤ 1.5 ULN (not receiving anticoagulant therapy);
- Cardiac ultrasound EF value ≥ 55%;
- Women of childbearing age who tested negative for serum pregnancy test 14 days before randomization;
- ECOG score ≤ 1 point;
- Voluntary signing of informed consent
- There is evidence of metastatic breast cancer (in order to exclude metastatic breast cancer, chest and abdomen CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT...
- Have Received chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. for this disease;
- The patient has a second primary malignant tumor, in addition to: fully treated skin cancer;
- Received treatment with anti-PD-1, anti-PDL1, anti-PD-L2 drugs, or other immunotherapy;
- Diagnosed with immunodeficiency or autoimmune diseases;
- Severe lung or heart disease;
- Hepatitis B and C are in active phase;
- History of organ transplantation or bone marrow transplantation;
- Pregnant or lactating women;
- Due to serious and uncontrollable medical conditions, researchers believe there are contraindications to chemotherapy;
- Screening for clinically significant bleeding symptoms or significant bleeding tendencies within the previous month;
- Screening for arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism that occurred within the previous 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, 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.