NCT03994107

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

June 19, 2019

Last Update Submit

January 20, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response(pCR) rate

    Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery

    5 months

Secondary Outcomes (3)

  • Rate of Breast conserving surgery

    5 months

  • Rate of surgery

    5 months

  • adverse events

    5 months

Study Arms (1)

PLD/albumin-bound paclitaxel/Trastuzumab

EXPERIMENTAL

First phase PLD: Level 1：30mg/m2； Level 2：35mg/m2； Level 3：40mg/m2； IV, d1, q21d×6. albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6. Trastuzumab：8mg/kg IV for the first infusion , Subsequent infusions 6mg/kg. d1, q21d×6. Second phase PLD: maximum tolerated dose (MTD). IV, d1, q21d×6. albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6. Trastuzumab：8mg/kg IV for the first infusion ,Subsequent infusions 6mg/kg. d1, q21d×6.

Drug: Pegylated Liposomal DoxorubicinDrug: Albumin-bound paclitaxelDrug: Trastuzumab

Interventions

Pegylated Liposomal DoxorubicinDRUG

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

PLD/albumin-bound paclitaxel/Trastuzumab
Albumin-bound paclitaxelDRUG

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

PLD/albumin-bound paclitaxel/Trastuzumab
TrastuzumabDRUG

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

PLD/albumin-bound paclitaxel/Trastuzumab

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
  • Female patients aged from 18 to 70 years old;
  • Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible;
  • Clinical stageⅡ-Ⅲ;
  • HER-2 Positive（defined by: IHC 3+ or ISH positive）;
  • Without previous treatment for this breast cancer;
  • Patients must have at least one measurable disease according to RECIST 1.1;
  • ECOG (Eastern Cooperative Oncology Group) performance score of 0-1 points;
  • LVEF≥55%;
  • Normal ECG;
  • Bone marrow function:absolute neutrophil count (ANC)≥2.0×109/L，platelets≥100×109/L，hemoglobin ≥90g/L。
  • Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤1.5×ULN，serum total bilirubin≤ ULN;
  • Renal function：serum creatinine≤1.5×ULN； Coagulation function：the international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) ≤1.5×ULN.

You may not qualify if:

  • New York Heart Association (NYHA) class ≥Ⅱ heart failure.
  • Known or suspected hypersusceptibility to any agents used in the treatment protocol.
  • Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator.
  • participating in other clinical trials within 4 weeks before this study.
  • Serious heart disease, including but not limited to:
  • \) Significant ventricular arrhythmia or high degree atrioventricular block (Mobitz II or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) Electrocardiogram shows transmural myocardial infarction; 5) Uncontrolled hypertension. 6. Uncontrolled diabetes. 7. Severe or uncontrolled infection. 8. Hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (HIV) antibody positive.
  • \. Active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin，within the past 5 years.
  • ）Women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation.
  • ）Other conditions considered to be inappropriate to be enrolled by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fei Ma

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinAlbumin-Bound PaclitaxelTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulins

Study Officials

  • Fei Ma, MD

    Cancer Hospital Chinese Academy of Medical Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Ma, MD

CONTACT

+861391021778013910217780@139.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 21, 2019

Study Start

October 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

CN(1)