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Targeted Next Generation Sequencing for the Efficacy of Trastuzumab Neoadjuvant Chemotherapy in Breast Cancer

NCT03728829 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-07-09

No results posted yet for this study

Summary

To explore the genetic background of patients with HER2 positive breast cancer that benefit from trastuzumab combined with neoadjuvant chemotherapy, identify clinically actionable mutations that associated with trastuzumab resistance or drug efficacy, we designed this Observational phase II trial. The primary endpoint is genetic profile of HER2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy. Secondary endpoints included pathological complete response (pCR) rate and safety.

Conditions

  • Observational
  • Prospective

Interventions

DRUG

Trastuzumab+TP

Trastuzumab (4 mg/kg loading dose, then 2 mg/kg I.V., every week, totally 17 weeks (6 cycles)) combined with TC neoadjuvant chemotherapy (Docetaxel 75 mg/m2 I.V., day 1, Carboplatin 400 mg/kg, I.V., day 2, every 3 weeks, totally 6 cycles).

Sponsors & Collaborators

  • OrigiMed

    collaborator INDUSTRY

  • Hebei Medical University Fourth Hospital

    lead OTHER

Principal Investigators

  • Baoen Shan, MD,PhD · Hebei Medical University Fourth Hospital

Eligibility

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

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2022-10-30
Completion
2022-12-31

Countries

  • China

Study Locations

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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 NCT03728829 on ClinicalTrials.gov