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Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT

NCT04137653

Description:

Triple-negative breast cancer (TNBC) accounts for about 20% of clinical breast cancer. Clinical characteristics include early onset, high malignancy and heterogeneity. There is no effective drug target for TNBC, resulting in poor outcomes, high relapse rate and distant metastasis. So, further research on TNBC pathological features is particularly important. Compared with the solvent-based paclitaxel, albumin-bound paclitaxel (nab-P) demonstrates a stronger therapeutic effect. With albumin nanoparticles as a carrier, nab-P increases the concentration of extra-tumor drugs by passing through the albumin receptor (Gp60) transmembrane pathway and the secreted protein acidic and rich in cysteine (SPARC) approach that binds to the extracellular matrix of the tumor. Numerous clinical trials have found that nab-P is superior to the solvent-based paclitaxel in the treatment of breast cancer, especially in breast cancer with poor prognosis. However, the current efficacy of nab-P in the treatment of TNBC has not been fully verified. The mechanism underlying the killing effect of nab-P on TNBC breast cancer cells remains unclear yet. This trial will compare the therapeutic effect of nab-P with solvent-based paclitaxel in TNBC patients, and seek for important scientific clues, scientific evidence, and clinical data for nab-P in the treatment of TNBC.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT
  • Official Title: Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective Randomized Controlled Clinical Trial

Clinical Trial IDs

  • ORG STUDY ID: Shengjing-LCG004
  • NCT ID: NCT04137653

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
nab-Paclitaxel+carboplatinnab-Paclitaxel groupnab-Paclitaxel group
Paclitaxel+carboplatinPaclitaxel grouppaclitaxel group

Purpose

Triple-negative breast cancer (TNBC) accounts for about 20% of clinical breast cancer. Clinical characteristics include early onset, high malignancy and heterogeneity. There is no effective drug target for TNBC, resulting in poor outcomes, high relapse rate and distant metastasis. So, further research on TNBC pathological features is particularly important. Compared with the solvent-based paclitaxel, albumin-bound paclitaxel (nab-P) demonstrates a stronger therapeutic effect. With albumin nanoparticles as a carrier, nab-P increases the concentration of extra-tumor drugs by passing through the albumin receptor (Gp60) transmembrane pathway and the secreted protein acidic and rich in cysteine (SPARC) approach that binds to the extracellular matrix of the tumor. Numerous clinical trials have found that nab-P is superior to the solvent-based paclitaxel in the treatment of breast cancer, especially in breast cancer with poor prognosis. However, the current efficacy of nab-P in the treatment of TNBC has not been fully verified. The mechanism underlying the killing effect of nab-P on TNBC breast cancer cells remains unclear yet. This trial will compare the therapeutic effect of nab-P with solvent-based paclitaxel in TNBC patients, and seek for important scientific clues, scientific evidence, and clinical data for nab-P in the treatment of TNBC.

Detailed Description

      Breast cancer has been one of the most common malignant tumors with highest morbidity and
      mortality that threatens women's health worldwide. Among US women, there were 250,000 new
      invasive breast cancers and 40,000 breast cancer deaths in 2017. In the US, 12.4% women
      develop breast cancer in their lifetime, and the incidence of breast cancer in women over 50
      years of age has increased significantly. Although the development of molecular typing and
      comprehensive treatments have significantly improved the prognosis of breast cancer patients,
      the recurrence and metastasis of breast cancer is still the main cause of death in breast
      cancer patients.

      TNBC accounts for about 20% of clinical breast cancer. Clinical characteristics include early
      onset, high malignancy and heterogeneity. There is no effective drug target for TNBC,
      resulting in poor outcomes, high relapse rate and distant metastasis. So, further research on
      TNBC pathological features is particularly important.

      Paclitaxel is a natural secondary metabolite isolated and purified from the bark of Taxus
      chinensis. It has been clinically proven to have a good anti-tumor effect. However,
      polyoxyethylene castor oil/ethanol is often used as a solvent for paclitaxel in clinical
      practice, and this solvent-based paclitaxel is prone to causing severe allergic reactions,
      even aggravating myelosuppression and neurotoxicity. In addition, the solvent-based
      paclitaxel can also influence the efficacy of other drugs by inhibiting albumin-mediated drug
      delivery. nab-P is a novel paclitaxel that can compensate for the adverse effects of
      solvent-based paclitaxel and have good efficacy and safety. Compared with the solvent-based
      paclitaxel, nab-P demonstrates a stronger therapeutic effect. With albumin nanoparticles as a
      carrier, nab-P increases the concentration of extra-tumor drugs by passing through the
      albumin receptor (Gp60) transmembrane pathway and the secreted protein acidic and rich in
      cysteine (SPARC) approach that binds to the extracellular matrix of the tumor. Numerous
      clinical trials have found that nab-P is superior to the solvent-based paclitaxel in the
      treatment of breast cancer, especially in breast cancer with poor prognosis. However, the
      current efficacy of nab-P in the treatment of TNBC has not been fully verified. The mechanism
      underlying the killing effect of nab-P on TNBC breast cancer cells remains unclear yet.

      This trial will compare the therapeutic effect of nab-P with solvent-based paclitaxel in TNBC
      patients, and seek for important scientific clues, scientific evidence, and clinical data for
      nab-P in the treatment of TNBC.
    

Trial Arms

NameTypeDescriptionInterventions
nab-Paclitaxel groupExperimental749 patients will be assigned into nab-Paclitaxel group.
  • nab-Paclitaxel+carboplatin
paclitaxel groupActive Comparator749 patients will be assigned into paclitaxel group
  • Paclitaxel+carboplatin

Eligibility Criteria

        Inclusion Criteria:

          -  breast cancer is confirmed by the mammography, and the immunohistochemical results of
             cancer tissues are negative for estrogen receptor, progesterone receptor and
             anti-human epidermal growth factor receptor 2;

          -  positive for axillary lymph node metastasis;

          -  18-70 years of age, female;

          -  patients have good compliance with the planned treatment, who are volunteer to
             participate in the study, are willing to be treated with solvent-based paclitaxel or
             nab-P at random, and provide written informed consent with the premise of fully
             understanding the study protocol.

        Exclusion Criteria:

          -  pregnant and lactating women;

          -  distant metastasis;

          -  patients with a history of other cancers or who have received radiotherapy on the
             chest;

          -  abnormalities in blood tests or presence of other symptoms of infection;

          -  allergy to paclitaxel;

          -  patients who have psychotropic drug abuse until now or those with a history of mental
             disorders;

          -  abnormalities in important organs such as the heart, lung, liver and kidney;

          -  patients who have participated in other clinical trials.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic complete response (PCR)
Time Frame:At 5 years of treatment
Safety Issue:
Description:Pathologic complete remission refers to no invasive tumor cell remnants in the pathological examination of the primary mammary gland and axillary lymph nodes surgically removed. The PCR indicates the proportion of the patients with pathological complete remission to the total number of patients.

Secondary Outcome Measures

Measure:Proportion of tumor stem cells in the lesion
Time Frame:At 9 and 18 weeks of treatment
Safety Issue:
Description:The CD44/CD24 expression in the breast tissues will be detected by immunohistochemistry before treatment and at 9 and 18 weeks of treatment, to determine the proportion of tumor stem cells in the lesion.
Measure:Progression-free survival (PFS)
Time Frame:Within 5 years of follow-up
Safety Issue:
Description:PFS refers to the time from random enrollment to disease progression or death for any reason indicated by imaging findings. PFS will be recorded within 5 years of follow-up.
Measure:Overall survival (OS)
Time Frame:Within 5 years of follow-up
Safety Issue:
Description:OS refers to the time from enrollment to death
Measure:Adverse events
Time Frame:in 5 years
Safety Issue:
Description:Any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Shengjing Hospital

Trial Keywords

  • paclitaxel
  • albumin-bound paclitaxel
  • neoadjuvant therapy

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