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OpenTrials
Completed

NCT Number: NCT03221881

Neoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in Breast Cancer

In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MRI

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with newly diagnosed breast cancer;
  • Age >18 years;
  • Eastern Cooperative Group (ECOG) performance status 0-2;
  • measurable disease (as per radiological imaging); life
  • expectancy >12 months;
  • adequate haematologic blood profile;
  • normal liver and kidney function;
  • adequate cardiac function;
  • no metastatic disease;
  • negative pregnancy test (premenopausal women);
  • signed informed consent.

Exclusion criteria

  • Level 2 cardiac toxic effects were defined as asymptomatic systolic dysfunction (NYHA class I) or mildly symptomatic heart failure (NYHA class II) ;
  • Previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures);
  • Active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;

Treatment and study plan

Pegylated Liposomal Doxorubicin and docetaxel

Drug

Other names: Pegylated Liposomal Doxorubicin 30-35 mg/m (2) and docetaxel 75-80 mg/m(2) were both administered on day 1,intravenous, Cycles were repeated in 3-week intervals,for 6 cycles.

Primary outcomes

  1. PCR rate

    Time frame: 12 months

    pathologic complete response rate

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Registry information

Official study title

The Effectiveness and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Breast Cancer.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2017
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.