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

NCT04137653 | Recruiting Phase 3 DMC

• 1 other identifier: Shengjing-LCG004
• Study Type: interventional
• Target: 1,498
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

paclitaxel; albumin-bound paclitaxel; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  At 5 years of treatment

Secondary Outcomes (4)

• Proportion of tumor stem cells in the lesion

  At 9 and 18 weeks of treatment

• Progression-free survival (PFS)

  Within 5 years of follow-up

• Overall survival (OS)

  Within 5 years of follow-up

• Adverse events

  in 5 years

Study Arms (2)

nab-Paclitaxel group

EXPERIMENTAL

749 patients will be assigned into nab-Paclitaxel group.

Drug: nab-Paclitaxel+carboplatin

paclitaxel group

ACTIVE COMPARATOR

749 patients will be assigned into paclitaxel group

Drug: Paclitaxel+carboplatin

Interventions

nab-Paclitaxel+carboplatin DRUG

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

nab-Paclitaxel group

Paclitaxel+carboplatin DRUG

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

paclitaxel group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CP protocol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Caigang Liu, M.D., Ph.D.

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Gu, M.D.

CONTACT

+86 18940255116; jadegx@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: July 19, 2021
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

CN (1)