NCT01019616

Brief Summary

The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.

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
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

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

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 4, 2011

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

11.3 years

First QC Date

November 24, 2009

Last Update Submit

November 26, 2021

Conditions

Primary Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • distant disease-free survival (DDFS)

    3 years after surgery

Study Arms (2)

Chemotherapy

EXPERIMENTAL
Drug: paclitaxel/anthracycline

Control

NO INTERVENTION

Interventions

paclitaxel/anthracyclineDRUG

standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)

Also known as: Alternative Non-cross-resistant Adjuvant Chemotherapy
Chemotherapy

Eligibility Criteria

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

You may qualify if:

  • Female patients, age ≦65 years
  • Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer
  • Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel)
  • Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
  • Postoperative residual positive lymph nodes or G1/G2/G3 of Miller \& Payne Grading System
  • Adequate recovery from recent surgery
  • No history of other malignancies
  • No currently uncontrolled diseased or active infection
  • Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
  • Adequate cardiovascular function reserve with a myocardial infarction within the past six month
  • Adequate hematologic function with:
  • Absolute neutrophil count (ANC) ≥1500/mm3
  • Platelets ≥100,000/ mm3
  • Hemoglobin ≥10 g/dL
  • Adequate hepatic and renal function with:
  • +6 more criteria

You may not qualify if:

  • Known or suspected distant metastases
  • Concurrent malignancy or history of other malignancy
  • Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
  • Geographical, social, or psychological problems that would compromise study compliance
  • Known or suspected hypersensitivity to anthracycline or paclitaxel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

307 Hospital of Pla

Beijing, China

Location

Beijing Cancer Hospital Breast Center

Beijing, China

Location

Beijing Chao-Yang Hospital

Beijing, China

Location

Cancer Institution and Hospital.Chinese Academy of Medical Sciences

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Peking University People'S Hospital

Beijing, China

Location

MeSH Terms

Interventions

PaclitaxelAnthracyclines

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Tao Ouyang, Doctor

    Beijing Cancer Hospital Breast Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman of Breast Center

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

March 4, 2011

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 29, 2021

Record last verified: 2021-11

Locations

CN(7)