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.
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
Interventions
Drug | Synonyms | Arms |
---|
nab-Paclitaxel+carboplatin | nab-Paclitaxel group | nab-Paclitaxel group |
Paclitaxel+carboplatin | Paclitaxel group | paclitaxel 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
Name | Type | Description | Interventions |
---|
nab-Paclitaxel group | Experimental | 749 patients will be assigned into nab-Paclitaxel group. | - nab-Paclitaxel+carboplatin
|
paclitaxel group | Active Comparator | 749 patients will be assigned into paclitaxel group | |
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: | Recruiting |
Lead Sponsor: | Shengjing Hospital |
Trial Keywords
- paclitaxel
- albumin-bound paclitaxel
- neoadjuvant therapy
Last Updated
July 20, 2021