Combination therapy for early triple-negative breast cancer

Nab-P+Cb+PD1 Inhibitor Neoadjuvant Therapy for Early TNBC: a Single Center, Non Blinded, Randomized Phase II Clinical Trial

This study is testing a new combination of medications to see if it helps people with early-stage triple-negative breast cancer respond better to treatment before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Camrelizumab
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06817525 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 with clinically confirmed early-stage triple-negative breast cancer and measurable lesions.

Not a fit: Patients with non-triple-negative breast cancer or those with severe comorbidities that contraindicate chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with early-stage triple-negative breast cancer by enhancing the rates of pathological complete response.

How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and immunotherapy in treating triple-negative breast cancer, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Zhengzhou, Henan

• Henan cancer hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Zhenzhen Liu — Henan Cancer Hospital
• Study coordinator: Zhenzhen Liu

Conditions Triple-negative Breast Cancer; Pathological complete remission rate; Triple-negative breast cancer; Camrelizumab; Neoadjuvant therapy