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Triple-Negative Breast CancerPhase 2NCT05953168

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

A Phase 2 study testing Trastuzumab Deruxtecan in people with Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Triple-Negative Breast Cancer
What is being tested?
Trastuzumab Deruxtecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteChina
Study dates
Aug 2023to Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged 18-70 years old;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score 0 or 1;
  • Expected lifetime of not less than three months;
  • Disease-free interval >6 months；
  • Adequate tumor tissue samples collected within a time frame of less than 3 months;
  • 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);
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  • Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1);
  • Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resected;
  • Adequate hematologic and end-organ function, laboratory test results;
  • 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.
  • Female subjects with fertility are required to use a medically approved contraceptive method during the study treatment；
  • 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.

Who cannot join

  • 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)；
  • History of clinically uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmias；
  • Common Terminology Criteria for Adverse Events (CTCAE) grade ≥1 adverse reactions attributed to previous treatments；
  • Underwent major surgery (excluding outpatient minor procedures, such as placement of vascular access) within the first 3 weeks of the investigational treatment；
  • Pregnant or lactating patients；
  • History of malignancy within the past five years (excluding cured basal cell carcinoma and cervical carcinoma in situ)；
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  • Presence of third-space fluid accumulation (such as significant pleural effusion and ascites) that cannot be controlled by drainage or other methods；
  • 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)；
  • 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；
  • Individuals with allergies or a history of known allergy to components of the study drugs or other monoclonal antibodies；
  • History of immunodeficiency, including HIV-positive test results, acquired or congenital immunodeficiency diseases, or history of organ transplantation. Positive syphilis antibody test；
  • 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.

Trial locations and contacts

1 site in 1 country.

Zhimin Shao, MD, PhD contact

+86-021-64175590 ext. 8808

zhimingshao@yahoo.com

China1 site

  • Breast cancer institute of Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: 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.

Being tested
Trastuzumab Deruxtecan
Keywords
triple-negative breast cancer, T-DXd treatment
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab DeruxtecanDrug

    Trastuzumab Deruxtecan for TNBC-LAR patients with HER2 low expression

Study groups in NCT05953168
Study groupRoleWhat they receive
Trastuzumab Deruxtecan (T-DXd)ExperimentalNot described
Receives: Drug: Trastuzumab Deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response of Complete Response (ORR)

    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

    Measured: 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 outcomes (4)

  1. Duration of response (DOR)

    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

    Measured: 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)

  2. Disease Control Rate (DCR)

    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.

    Measured: 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)

  3. Progression Free Survival (PFS)

    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.

    Measured: 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)

  4. Overall Survival (OS)

    Defined as the time from enrollment to the date of death from any cause.

    Measured: Every 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study startAug 2023 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05953168
Sponsor's protocol ID
SCHBCC-N059
Status last verified
Jul 2023
First submitted
12 Jul 2023
Last updated
19 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab Deruxtecan in people with Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhimin Shao, MD, PhD (+86-021-64175590 ext. 8808, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05953168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.

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