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A randomized controlled trial for the effect and safety of albumin-bound paclitaxel neoadjuvant therapy for triple-negative breast cancer patients

A randomized controlled trial for the effect and safety of albumin-bound paclitaxel neoadjuvant therapy for triple-negative breast cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026501
Enrollment
Unknown
Registered
2019-10-12
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Group 1:nab-P as neoadjuvant therapy
Group 2:paclitaxel as neoadjuvant therapy

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 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; 2. positive for axillary lymph node metastasis; 3. Aged 18-70 years female; 4. 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

Exclusion criteria: 1. pregnant and lactating women; 2. distant metastasis; 3. patients with a history of other cancers or who have received radiotherapy on the chest; 4. abnormalities in blood tests or presence of other symptoms of infection; 5. allergy to paclitaxel; 6. patients who have psychotropic drug abuse until now or those with a history of mental disorders; 7. abnormalities in important organs such as the heart, lung, liver and kidney; 8. patients who have participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Pathologic complete response;

Secondary

MeasureTime frame
Proportion of tumor stem cells in the lesion;Progression-free survival;Overall survival;Adverse events;

Countries

China

Contacts

Public ContactCaigang Liu

Shengjing Hospital of China Medical University

liucg@sj-hospital.org+86 18940254967

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026