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National Surgical Adjuvant Study of Breast Cancer(N-SAS BC) 07 [RESPECT]

NCT01104935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2019-10-21

No results posted yet for this study

Summary

To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized controlled trial in women over 70 years with human epidermal growth factor receptor type-2 (HER2) positive primary breast cancer.

Conditions

Interventions

DRUG

trastuzumab monotherapy

DRUG

trastuzumab and chemotherapy

Sponsors & Collaborators

  • Comprehensive Support Project for Oncology Research

    lead OTHER

Principal Investigators

  • Masataka Sawaki · Department of Breast Oncology, Aichi Cancer Center Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-28
Primary Completion
2017-10-31
Completion
2018-10-15

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT01104935 on ClinicalTrials.gov