Nab-P+Cb+PD1 Inhibitor Combined/not Combined with Bevacizumab Neoadjuvant Therapy for Early TNBC: a Single Center, Non Blinded, Randomized Phase II Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab combined/not combined with bevacizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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;

⁃ Urine test: Urine protein\<2+; If urine protein is ≥ 2+, the 24-hour urine protein quantification display must show protein ≤ 1g

⁃ 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

Locations
Other Locations
China
Henan cancer hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Zhenzhen Liu
liuzhenzhen73@126.com
13603862755
Backup
Yajie Zhao
Zlyyzhaoyajie4399@zzu.edu.cn
17319303256
Time Frame
Start Date: 2024-11-06
Estimated Completion Date: 2025-11-06
Participants
Target number of participants: 64
Treatments
Active_comparator: 6*Chemotherapy drugs(Nab-P, d1, Cb, d1)+6*Immunosuppressants(d1)
Group A: 6\*Albumin-bound paclitaxe (260 mg/m²,d 1)+6\*Carboplatin (AUC=5, d 1)+6\*Camrelizumab (200 mg, d 1);
Active_comparator: 6*Chemotherapy drugs(Nab-P, d1,8,15, Cb, d1)+6*immunosuppressants(d1, )
Group B: 6\*Albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+6\*Carboplatin (AUC=5, d 1 )+6\*Camrelizumab (200 mg, d 1);
Experimental: 6*Chemotherapy drugs (Nab-P, d1, Cb, d1)+6*Immunosuppressants (d1)+5*anti-angiogenic drugs (d1)
Group C: 6\*Albumin-bound paclitaxe (260 mg/m²,d 1, 6 cycles)+6\*Carboplatin (AUC=5,d 1, 6 cycles)+6\*Camrelizumab (200 mg, , d 1, 6 cycles)+5\*Bevacizumab (15mg/kg, d 1,5 cycles);
Experimental: 6*Chemotherapy drugs (Nab-P, d1,8,15, Cb, d1)+6*Immunosuppressants (d1)+5*anti-angiogenic drugs (d1)
Group D: 6\*Albumin-bound paclitaxe (125 mg/m²,d 1,8,15,6 cycles)+6\*Carboplatin (AUC=5, d 1, 6 cycles)+6\*Camrelizumab (200 mg, d 1, 6 cycles)+5\*Bevacizumab (15mg/kg, d 1,5 cycles);
Sponsors
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov

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