Combination therapy for early triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of a combination of albumin-bound paclitaxel, carboplatin, and Camrelizumab, with and without Bevacizumab, as neoadjuvant therapy for patients with early-stage triple-negative breast cancer (TNBC). A total of 64 participants will be randomly assigned to four different treatment groups, each receiving varying dosages and combinations of the drugs over six cycles. The primary goal is to assess the pathological complete response rate, while secondary endpoints include overall response rate and survival metrics. The study aims to optimize treatment regimens and explore the immune microenvironment's role in treatment efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 18-65 years old;
2. Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis;
3. 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)
4. Clinically measurable lesions:

   Measurable lesions displayed by ultrasound, mammography, or MR (optional) within one month prior to screening;
5. 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);
6. Cardiac ultrasound EF value ≥ 55%;
7. Women of childbearing age who tested negative for serum pregnancy test 14 days before randomization;
8. ECOG score ≤ 1 point;
9. Voluntary signing of informed consent

Exclusion Criteria:

1. 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 scanning can be used as an alternative imaging inspection method);
2. Have Received chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. for this disease;
3. The patient has a second primary malignant tumor, in addition to: fully treated skin cancer;
4. Received treatment with anti-PD-1, anti-PDL1, anti-PD-L2 drugs, or other immunotherapy;
5. Diagnosed with immunodeficiency or autoimmune diseases;
6. Severe lung or heart disease;
7. Hepatitis B and C are in active phase;
8. History of organ transplantation or bone marrow transplantation;
9. Pregnant or lactating women;
10. Due to serious and uncontrollable medical conditions, researchers believe there are contraindications to chemotherapy;
11. Screening for clinically significant bleeding symptoms or significant bleeding tendencies within the previous month;
12. Screening for arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism that occurred within the previous 3 months.

Where it's running

• Henan cancer hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Zhenzhen Liu — Henan Cancer Hospital
• Study coordinator: Zhenzhen Liu
• Email: liuzhenzhen73@126.com
• Phone: 13603862755

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Granzyme B-PET to see if immunotherapy works in TNBC

  This study will test whether a Granzyme B PET/CT scan can help predict how well immunotherapy will work for adults with locally advanced or metastatic triple-negative breast cancer receiving an immune checkpoint inhibitor.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.