T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients

July 12, 2023 updated by: Zhimin Shao, Fudan University

An Open-label, Single-arm Phase II Trial of First-line Treatment With Trastuzumab Deruxtecan for Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer, Luminal Androgen Receptor Subtype With Low Human Epidermal Growth Factor Receptor 2 (HER2) Expression.

This is an open-label, single-arm phase II trial of first-line treatment with trastuzumab deruxtecan (T-DXd) for patients with locally advanced or metastatic triple-negative breast cancer, luminal androgen receptor subtype (TNBC-LAR) with low HER2 expression.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Breast cancer institute of Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women aged 18-70 years old;
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score 0 or 1;
  3. Expected lifetime of not less than three months;
  4. Disease-free interval >6 months；
  5. Adequate tumor tissue samples collected within a time frame of less than 3 months;
  6. Histological results recorded as TNBC [negative HER2, ER, and progesterone receptor (PgR) status] and LAR subtype according to the classification of Fudan University Shanghai Cancer Center (FUSCC);
  7. Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1);
  8. Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resected;
  9. Adequate hematologic and end-organ function, laboratory test results;
  10. Within the 3 weeks prior to study initiation, patients have not received radiotherapy, endocrine therapy, targeted therapy, or surgery, and have recovered from acute toxicities associated with previous treatments (if surgery was performed, wound healing is complete); no peripheral neuropathy or grade I peripheral neurotoxicity.
  11. Female subjects with fertility are required to use a medically approved contraceptive method during the study treatment；
  12. Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.

Exclusion Criteria:

  1. Use of radiotherapy (except for palliative reasons), chemotherapy, and immunotherapy in the 3 weeks prior to treatment, excluding bisphosphonates (which can be used for bone metastasis)；
  2. History of clinically uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmias；
  3. Common Terminology Criteria for Adverse Events (CTCAE) grade ≥1 adverse reactions attributed to previous treatments；
  4. Underwent major surgery (excluding outpatient minor procedures, such as placement of vascular access) within the first 3 weeks of the investigational treatment；
  5. Pregnant or lactating patients；
  6. History of malignancy within the past five years (excluding cured basal cell carcinoma and cervical carcinoma in situ)；
  7. Presence of third-space fluid accumulation (such as significant pleural effusion and ascites) that cannot be controlled by drainage or other methods；
  8. Non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid hormone therapy, current ILD/non-infectious pneumonia, or suspected ILD/non-infectious pneumonia that cannot be ruled out by imaging examinations during screening (Note: Subjects found to have ILD/non-infectious pneumonia during baseline screening chest CT are ineligible)；
  9. Known active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection or HBV DNA ≥500, or patients with chronic phase accompanied by abnormal liver function；
  10. Individuals with allergies or a history of known allergy to components of the study drugs or other monoclonal antibodies；
  11. History of immunodeficiency, including HIV-positive test results, acquired or congenital immunodeficiency diseases, or history of organ transplantation. Positive syphilis antibody test；
  12. According to the investigator's judgment, any evidence of diseases that the investigator considers unfavorable for the subject's participation in the study or that may affect their adherence to the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trastuzumab Deruxtecan (T-DXd)
Drug: Trastuzumab Deruxtecan
Trastuzumab Deruxtecan for TNBC-LAR patients with HER2 low expression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response of Complete Response (ORR)
Time Frame: 3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first)
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in all Participants
3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: 3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first)
Length of time that a tumor continues to respond to treatment without the cancer Duration of response is the time from response to progression/death
3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first)
Disease Control Rate (DCR)
Time Frame: 3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first)
Proportion of all subjects receiving study therapy whose best overall response is complete response (CR), partial response (PR), and stable disease (SD) for 8 weeks or more according to RECIST v1.1 criteria.
3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first)
Progression Free Survival (PFS)
Time Frame: 3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first)
Defined as the date from enrollment to the first recording of tumor progression (as measured by RECIST v1.1 criteria with or without continued treatment) or the date of death from any cause, whichever occurs first.
3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first)
Overall Survival (OS)
Time Frame: Every 6 months
Defined as the time from enrollment to the date of death from any cause.
Every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHBCC-N059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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