MedTrace Logo

Biomarkers Investigation of Neoadjuvant Chemotherapy for Breast Cancer

NCT03242551 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-11-14

No results posted yet for this study

Summary

The BINC-B trial is a diagnostic and interventional study in which various function imaging methods as Magnetic Resonance Imaging (PWI, DWI and DCE-MRI) and will be compared with common imaging methods (mammography and/or ultrasound) to investigate if an early response to a combined neoadjuvant chemotherapy in operable or potentially operable breast cancer. For breast cancer patients with positive HER-2, additional Herceptin could improve the response further. In this study the efficacy of combined neoadjuvant therapy with or without Herceptin should be evaluated and the role in predicting the tumor response with different imaging should be estimated.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Chemotherapy

"AC" followed by "T" Chemotherapy with or without trastuzumab, i.e. Epirubicin 100mg/m2 and cyclophosphamine 600mg/m2 for four cycles followed by paclitaxol 175mg/m2 for four cycles with (for patients with positive HER-2) or without Trastuzumab (loading dose of 6 mg/kg followed by 4 mg/kg every 2 weeks for four cycles), each cycle is 14 days.

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • Wenyong Tan, Dr. · Shenzhen People Hospital

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2022-08-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03242551 on ClinicalTrials.gov