A Phase 3 interventional study of nab-Paclitaxel+carboplatin and Paclitaxel+carboplatin in Breast Cancer, sponsored by Shengjing Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-20.
Sponsored by Shengjing Hospital · Phase 3, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 1,498 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Shengjing Hospital is the lead sponsor of 124 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
749 patients will be assigned into nab-Paclitaxel group.
Drug: nab-Paclitaxel+carboplatin
749 patients will be assigned into paclitaxel group
Drug: Paclitaxel+carboplatin
Nab-P (Abraxis BioScience, LLC., Mclrose Park, IL, USA; drug license No. H20091059), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; drug license No. Guoji Zhunzi H20020181), AUC=2 mg•min/mL, intravenous drip for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.
Also known as: nab-Paclitaxel group
Paclitaxel (Yangtze River Pharmaceutical Co., Ltd., Taizhou, Jiangsu Province, China; drug license No. Guoyao Zhunzi H20053001), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin, AUC=2 mg•min/mL, intravenous infusion for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.
Also known as: Paclitaxel group
Pathologic complete response (PCR)
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.
Time frame: At 5 years of treatment
Proportion of tumor stem cells in the lesion
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.
Time frame: At 9 and 18 weeks of treatment
Progression-free survival (PFS)
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.
Time frame: Within 5 years of follow-up
Overall survival (OS)
OS refers to the time from enrollment to death
Time frame: Within 5 years of follow-up
Adverse events
Any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment.
Time frame: in 5 years
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