Clincosm LogoSign in Get a demo

Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06125834
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to learn about the efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of patients with advanced HER2-positive breast cancer after TKIs or HP therapy. The main questions it aims to answer are:

  • The objective response rate of patients receiving T-DM1 therapy with advanced HER2-positive breast cancer after TKIs or HP therapy.

  • The adverse events and prognosis of patients with advanced HER2-positive breast cancer who receive the T-DM1 therapy.

  • Changes of anti-tumor immunity during T-DM1 therapy in patients with advanced HER2-positive breast cancer.

Participants will receive T-DM1 treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.

Condition or Disease Intervention/Treatment Phase
  • Drug: Trastuzumab Emtansine (T-DM1)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Trastuzumab Emtansine (T-DM1) Treatment in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy: a Multicenter, Single-arm, Phase II Study
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: T-DM1 treatment group

Trastuzumab Emtansine (T-DM1), 3.6mg/kg, d1/21, IVD, until progressive diseases or intolerable adverse effects occurs

Drug: Trastuzumab Emtansine (T-DM1)
Enrolled patients will receive Trastuzumab Emtansine (T-DM1) treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.

Outcome Measures

Primary Outcome Measures

  1. Objective response rate [up to 12 months]

Secondary Outcome Measures

  1. Progression-free survival [up to 36 months]

  2. Overall survival [up to 36 months]

  3. Adverse events [every 6 weeks]

  4. Antitumor immunity related parameters [up to 12 weeks]

    The changes of composition and function of immune cells in the tumor and peripheral blood before and after treatment

  5. Tumor related parameters [up to 12 weeks]

    Tumor heterogeneity before and after treatment its correlation with objective response rate, progression-free survival, overall survival, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age ≥ 18 years; pregnancy test (-) for premenopausal and perimenopausal patients, promising to use reliable contraception during treatment.

  • Patients who were be diagnosed with invasive breast cancer according to the eighth edition of American Joint Committee on Cancer (AJCC) staging system, and develop disease progression after anti-HER2 therapy (TKIs) for stage IV disease at initial diagnosis or within one year of adjuvant anti-HER2 therapy (HP) after surgery for early breast cancer.

  • At least one measurable lesion according to RECIST 1.1.

  • ECOG score of 0 or 1.

  • The organ function is still good and meets the following indicators: hemoglobin ≥ 90g/L, white blood cell ≥ 3.5×109/L, platelet ≥ 100×109/L, neutrophil ≥ 1.5×10^9/L, aspartate aminotransferase or alanine aminotransferase ≤ 3×ULN, total bilirubin ≤ 1.5×ULN, serum creatinine value ≤ 1.5×ULN.

  • Without myocardial ischemia in ECG.

  • NYHA grade I; Echocardiography LVEF ≥55%; Cardiac markers: cardiac troponin (cTnI) and brain natriuretic peptide (BNP) within normal range.

  • Complete all necessary baseline laboratory and radiological tests prior to treatment.

  • Complete clinical data.

Exclusion Criteria:

  • male breast cancer or inflammatory breast cancer.

  • Patients who have other malignant tumors or have contracted malignant tumors other than breast cancer in the past 5 years, except for basal cell carcinoma of the skin or flat cell carcinoma and carcinoma in situ of the cervix that have been adequately treated and controlled.

  • Accompanying other anti-tumor treatments or participating in other clinical trials.

  • Serious diseases that will affect the patient's compliance or put the patient at risk.

  • Major surgical procedures performed within 4 weeks prior to the commencement of study treatment or anticipated major surgical procedures during the course of the study.

  • Patients who have used ADC drugs at present or before this study.

  • History of allergic reactions or contraindications to use of any drug ingredient in this study.

  • Patients with chronic diarrhea and intestinal obstruction, as well as other diseases that affect drug administration and absorption.

  • Patients who have clinical cardiac symptoms or diseases that are not well controlled, such as: heart failure above NYHA 2; unstable angina; myocardial infarction occurred within one year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.

  • Dementia, intellectual abnormality, or any mental illness that interferes with the understanding of informed consent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China

Sponsors and Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT06125834
Other Study ID Numbers:
  • TEST-BC-2023
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Breast Neoplasms
Disease Progression
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine

Study Results

No Results Posted as of Nov 9, 2023