MedTrace Logo

Pegylated Liposomal Doxorubicin Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer

NCT03994107 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.

Conditions

Interventions

DRUG

Pegylated Liposomal Doxorubicin

First phase PLD: 30mg/m2；35mg/m2；40mg/m2；IV, d1, q21d×6. Second phase PLD：MTD. IV, d1, q21d×6.

DRUG

Albumin-bound paclitaxel

220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.

DRUG

Trastuzumab

8mg/kg IV for the first infusion. Subsequent infusions 6mg/kg. d1, q21d×6.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Peking Union Medical College

    lead OTHER

Principal Investigators

  • Fei Ma, MD · Cancer Hospital Chinese Academy of Medical Science

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-01-01
Completion
2021-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994107 on ClinicalTrials.gov