NCT03123770

Brief Summary

This is a multicentric, open-label,non-randomized concurrent control, 1:1 match,non-inferiority trial that assesses the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in breast cancer patients.

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
384

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started Dec 2016

Longer than P75 for phase_4 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

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

5 years

First QC Date

April 14, 2017

Last Update Submit

April 9, 2019

Conditions

Breast Cancer

Keywords

Breast cancerNeoadjuvant ChemotherapyPegylated liposomal doxorubicinPLD

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response rate

    The pathological complete response rate of primary lesion and axillary lymph nodes

    5 years

Secondary Outcomes (2)

  • Side effects

    5 years

  • Overall survival

    5 years

Study Arms (2)

DC Follow T

EXPERIMENTAL

Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.

Drug: Pegylated liposomal doxorubicinDrug: CyclophosphamideDrug: Docetaxel

EC Follow T

ACTIVE COMPARATOR

Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.

Drug: CyclophosphamideDrug: EpirubicinDrug: Docetaxel

Interventions

Pegylated liposomal doxorubicinDRUG

a new kind of doxorubicin

Also known as: PLD
DC Follow T
CyclophosphamideDRUG

traditional chemotherapy drug

Also known as: C
DC Follow TEC Follow T
EpirubicinDRUG

traditional chemotherapy drug used in breast cancer

Also known as: E
EC Follow T
DocetaxelDRUG

traditional chemotherapy drug used in breast cancer

Also known as: T
DC Follow TEC Follow T

Eligibility Criteria

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

You may qualify if:

  • Women aged : 18\~70 years.
  • WHO (ECOG) performance status 0-2.
  • Patients who have read and understand the informed consent form and have given written informed consent.
  • Diagnosed as invasive breast cancer by core biopsy
  • Diagnosed pre-surgically as (cTNM Staging)Stage II-III and suit for neoadjuvant chemotherapy.
  • Patients had previously not received chemotherapy，radiotherapy or biotherapy.
  • Normal organ function，meeting the requirement of laboratory testing below:
  • WBC≥4.0×109/L,
  • NEU≥1.5×109/L,
  • PLT≥100×109/L,
  • HB ≥10g/dL,
  • Scr≤1.5× ULN,
  • AST ≤2.5×ULN,
  • ALT ≤2.5×ULN,
  • TDIL≤1.5×ULN.
  • +1 more criteria

You may not qualify if:

  • Pregnant or lactating women were excluded.
  • History of receiving organ transplantation（including Autologous bone marrow transplantation and peripheral hematopoietic stem-cell transplantation).
  • Dysfunction of peripheral nerve system caused by other diseases or history of either severe mental disorder or central nervous system disorders.
  • Uncontrolled infection or severe peptic ulcer need treatment.
  • Severe hepatic disease（such as hepatic cirrhosis),nephrosis,respiratory disease or uncontrolled diabetes.
  • Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin.
  • Significant abnormal EKG or cardiac disease with drastic symptoms like congestive heart failure or severe coronary disease or uncontrolled arrhythmia or myocardial infarction within 12 months or NYHA level III-IV or LVEF\<55% .
  • Be allergic to test drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer institute

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (4)

  • O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004 Mar;15(3):440-9. doi: 10.1093/annonc/mdh097.

    PMID: 14998846BACKGROUND

  • Vici P, Pizzuti L, Gamucci T, Sergi D, Conti F, Zampa G, Del Medico P, De Vita R, Pozzi M, Botti C, Di Filippo S, Tomao F, Sperduti I, Di Lauro L. Non-pegylated liposomal Doxorubicin-cyclophosphamide in sequential regimens with taxanes as neoadjuvant chemotherapy in breast cancer patients. J Cancer. 2014 Apr 25;5(6):398-405. doi: 10.7150/jca.9132. eCollection 2014.

    PMID: 24847380BACKGROUND

  • Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martinez E, Martinez-Janez N, Mele M, Llombart A, Pernas S, Villagrasa P, Blasco C, Baselga J. Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study. Breast Cancer Res Treat. 2015 Jun;151(3):597-606. doi: 10.1007/s10549-015-3415-2. Epub 2015 May 16.

    PMID: 25981896BACKGROUND

  • Uriarte-Pinto M, Escolano-Pueyo A, Gimeno-Ballester V, Pascual-Martinez O, Abad-Sazatornil MR, Agustin-Ferrandez MJ. Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer. Int J Clin Pharm. 2016 Apr;38(2):446-53. doi: 10.1007/s11096-016-0278-5. Epub 2016 Mar 7.

    PMID: 26951122BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin1-dodecylpyridoxalCyclophosphamideEpirubicinDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Huang Jian, Dr

    Second Affiliated Hospital of Zhejiang University School of Medicine

    STUDY CHAIR

Central Study Contacts

Huang Jian, Dr

CONTACT

8657187315009drhuangjiang@zju.edu.cn

Zhang Zhigang, Dr

CONTACT

8657187315009zzg2011@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 21, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

CN(1)