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Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway

NCT04736589 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2021-02-03

No results posted yet for this study

Summary

This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzumab are enrolled and randomized to receive the treatment of Inetetamab plus Rapamycin plus chemotherapy or Pyrotinib plus chemotherapy.The study aimed to access the efficacy and safety of Inetetamab combined with Rapamycin and chemotherapy in HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway.

Conditions

Interventions

DRUG

Inetetamab

Initial dose of 8mg/kg, completed in 90 minutes IV infusion, and then 6 mg/kg over 30-90 minutes IV infusion every 3 weeks.

DRUG

Rapamycin

Oral 2mg, once a day.

DRUG

Pyrotinib

Oral 400mg, once a day.

DRUG

Chemotherapy

Chemotherapy drugs are not limited in this trial, please refer to their instructions for specific usage.

Sponsors & Collaborators

  • Peking Union Medical College

    lead OTHER

Principal Investigators

  • Fei Ma, MD · Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2024-02-02
Completion
2027-02-02

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT04736589 on ClinicalTrials.gov