NCT05207514

Brief Summary

Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

January 7, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

January 7, 2022

Last Update Submit

May 15, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0

    H \& E staining of tissues obtained from breast and axillary lymph nodes was defined as the absence of invasive cancer, and the proportion of subjects was determined.

    at the time of definitive surgery

Study Arms (2)

Nanoxel M

EXPERIMENTAL

AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M

Drug: Nanoxel MDrug: DoxorubicinDrug: Cyclophosphamide

Taxotere

ACTIVE COMPARATOR

AC(Doxorubicin, Cyclophosphamide) followed by Taxotere

Drug: TaxotereDrug: DoxorubicinDrug: Cyclophosphamide

Interventions

Nanoxel MDRUG

75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide

Also known as: polysorbate 80, ethanol free docetaxel
Nanoxel M
TaxotereDRUG

75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide

Also known as: docetaxel
Taxotere
DoxorubicinDRUG

60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide

Nanoxel MTaxotere
CyclophosphamideDRUG

600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.

Nanoxel MTaxotere

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were diagnosed with primary breast cancer by core biopsy
  • Patients who have been identified as HER2 negative in the tissue obtained through core needle biopsy and have confirmed the positive / negative status of ER (Estrogen receptor) and Progesterone receptor (PR)
  • HER2 positive is defined as IHC 3+ or FISH +
  • Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)

You may not qualify if:

  • Patients who have distant metastasis
  • Patients who have cystitis or urinary obstruction
  • Patients who have history of thromboembolism or coagulation disorder
  • Patients who have Interstitial lung disease ans liver cirrhosis ( \> Child-Pugh class B)
  • Patients who have Insulin-Dependent Type II diabete mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevrance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PolysorbatesDocetaxelDoxorubicinCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Joohyuk Sohn, M.D.,Ph.D.

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 26, 2022

Study Start

March 31, 2022

Primary Completion

February 7, 2024

Study Completion

May 9, 2024

Last Updated

May 17, 2024

Record last verified: 2023-05

Locations

KR(1)