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Breast Carcinoma in SituPhase 2NCT06843681

Trastuzumab Plus Taxane Neoadjuvant Therapy for HER2-Positive Breast Ductal Carcinoma In Situ (DCIS) : A Phase II Study

A Phase 2 study testing Trastuzumab combined with taxane neoadjuvant therapy in people with Breast Carcinoma in Situ, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is a phase II single-center single-arm clinical study designed to analyze the efficacy and safety of trastuzumab combined with taxane neoadjuvant therapy for HER2-positive breast carcinoma in situ (or with invasive carcinoma). Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Carcinoma in Situ
What is being tested?
Trastuzumab combined with taxane neoadjuvant therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
1 Mar 2025to 1 Jan 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Diagnosed breast carcinoma in situ (female, 18 to 70 years old);
  • Breast mass ≥2cm, and in situ cancer pathology confirmed HER2 positive (definition: immunohistochemical results 3+ or in situ hybridization results positive);
  • No evidence of distant transfer;
  • Have not received any previous cancer treatment;
  • Imaging examination showed at least one measurable lesion within 2 weeks before enrollment;
  • Left ventricular ejection fraction (LVEF) was measured by echocardiography ≥50%;
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  • Previous treatment-related toxicity should be alleviated to NCI CTCAE (version 5.0) ≤1 degree, AST and ALT≤2.5 times the upper limit of normal, total bilirubin ≤1.5 times the upper limit of normal;
  • Liver and kidney function tests are basically normal:
  • Total bilirubin (TBIL) ≤3× upper limit of normal (ULN),
  • Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤2.5×ULN (patients with liver metastasis ≤5xULN),
  • Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml/min;
  • Adequate bone marrow functional reserve:
  • White blood cell count (WBC) ≥3.0×10^9 / L,
  • Neutrophil count (ANC) ≥1.5×10^9 / L,
  • Platelet count (PLT) ≥70×10^9 / L
  • Fertile women must use contraceptives;
  • Be able to understand the research process, voluntarily participate in the study, and sign the informed consent.

Who cannot join

  • Metastatic breast cancer (stage IV);
  • History of invasive breast cancer, or prior systemic treatment to treat or prevent breast cancer;
  • Previous or concurrent malignant diseases, except skin basal cell carcinoma or cervical cancer in situ;
  • Patients with severe heart disease or discomfort that is not expected to tolerate chemotherapy, including but not limited to: fatal arrhythmias or higher grade atrioventricular block, unstable angina pectoris, clinically significant valvular disease, transmural myocardial infarction shown by electrocardiogram, uncontrolled hypertension;
  • Insufficient bone marrow or kidney function, liver function impairment;
  • Grade 2 or more severe peripheral neuropathy;
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  • Patients with thrombocytopenia, neutropenia, anemia, hypokalemia, and elevation of alanine aminotransferase or aspartate aminotransferase above CTCAE Level 1;
  • Patients who are known to be allergic to the active ingredient or other ingredient of the investigational drug;
  • Had received radiotherapy, chemotherapy, endocrine therapy, or was participating in any interventional drug clinical trial within 4 weeks prior to enrollment;
  • Pregnant or lactating women, women of childbearing age who refused to use effective contraception during the study period;
  • Any other conditions that the investigator considers the patient unfit to participate in the study, concomitant diseases or conditions that may interfere with study participation, or any serious medical disorder that may affect the safety of the subject (e.g., uncontrolled heart disease, high blood pressure, active or uncontrollable infection, active hepatitis B virus infection).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: Trastuzumab Combined With Taxane Neoadjuvant Therapy for HER2-positive Breast Carcinoma in Situ: a Phase II Single-arm Clinical Study

This is a phase II single-center single-arm clinical study designed to analyze the efficacy and safety of trastuzumab combined with taxane neoadjuvant therapy for HER2-positive breast carcinoma in situ (or with invasive carcinoma).

Read the detailed description

This Phase II single-center, single-arm clinical study was designed to evaluate the efficacy and safety of trastuzumab combined with taxane as a neoadjuvant treatment for patients with HER2-positive breast cancer in situ or invasive breast cancer. The study was designed to determine breast-conserving surgery rates and pathologic complete response (pCR) rates, assess tumor size reduction, and evaluate potential adverse events associated with treatment options. Participants will be treated with trastuzumab and taxane on a prescribed schedule, with periodic evaluations including imaging, histopathological analysis, and safety monitoring. The aim is to gain insight into the therapeutic potential of this combination therapy in improving outcomes for patients with HER2-positive breast cancer.

Being tested
Trastuzumab combined with taxane neoadjuvant therapy
Medical subject headings
Breast Carcinoma In Situ

What participants receive

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

  • Trastuzumab combined with taxane neoadjuvant therapyDrug

    Trastuzumab combined with taxane neoadjuvant therapy

Study groups in NCT06843681
Study groupRoleWhat they receive
treatmentExperimentalThe study includes a single treatment arm where all participants will receive a combination of trastuzumab and taxane as part of the neoadjuvant therapy. This treatment arm is designed to assess the efficacy and safety of the regimen in patients with HER2-positive breast carcinoma in situ 1. Trastuzumab (HER2-Targeted Therapy): * Trastuzumab will be administered intravenously at a standard dosage based on the patient's body weight. The initial dose will be a loading dose followed by maintenance doses every three weeks, as per clinical guidelines for HER2-positive breast cancer treatment. * The therapy targets the HER2 receptor to inhibit tumor growth and improve response rates. 2. Taxane (Chemotherapy): * A taxane-based chemotherapeutic agent (e.g., paclitaxel or docetaxel) will be administered intravenously. The specific agent, dosage, and schedule will follow standard protocols used in the neoadjuvant setting for HER2-positive breast cancer. * Taxanes work by disrupting microt
Receives: Drug: Trastuzumab combined with taxane neoadjuvant therapy

What is being measured

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

  1. Breast-conserving surgery rate after 4-6 cycles of treatment

    The breast-conserving surgery rate was calculated as a percentage of the total number of patients who successfully completed breast-conserving surgery after neoadjuvant therapy. For this study, all patients were required to confirm after treatment that the tumor was resectable and had no significant metastasis by imaging evaluation, such as breast ultrasound or MRI.

    Measured: From the start of neoadjuvant therapy to the completion of surgery (approximately 3-4 months after enrollment)

Secondary outcomes (8)

  1. pathological Complete Response (pCR)

    pCR refers to the situation in which a patient's carcinoma in situ tumor has completely disappeared through pathological examination after neoadjuvant therapy.

    Measurement Tool: Histopathological examination of surgical specimens.

    Measured: Within 3-4 months from enrollment, at the completion of neoadjuvant therapy.

  2. Objective Response Rate (ORR)

    ORR is the proportion of patients whose tumors have shrunk significantly over the course of treatment. Specifically, ORR includes both partial response (PR) and complete response (CR). Partial response (PR) : The maximum diameter or volume of the tumor is reduced by at least 30%, but it does not completely disappear. Complete response (CR) : The tumor disappears completely and no visible signs of cancer are confirmed by imaging tests, such as CT scans, MRI, or ultrasound.

    Measurement Tool: Imaging assessments (MRI, CT, or ultrasound).

    Measured: Within 3-4 months from enrollment, at the completion of neoadjuvant therapy.

  3. Event-free survival (EFS) of 3 years

    Event-free survival (EFS) is defined as the time from the initiation of neoadjuvant therapy to the first occurrence of disease progression, recurrence, second primary cancer, or death from any cause. In this study, 3-year EFS is defined as the proportion of patients who have not experienced any of these events within 36 months after starting treatment.

    Measurement Tool: Clinical and imaging follow-ups, verified by medical records.

    Measured: At 36 months from the date of enrollment.

  4. Event-free survival (EFS) of 5 years

    Measurement Tool: Clinical and imaging follow-ups, verified by medical records.

    Measured: At 60 months from the date of enrollment.

  5. Overall survival

    Measurement Tool: Survival status verified through medical records and patient follow-up.

    Measured: From enrollment to 60 months ± 3 months or until the date of death from any cause, whichever occurs first.

  6. Biomarker analysis o f HER2 and Ki-67 using immunohistochemistry (IHC) or quantitative PCR

    Measurement Tool: Expression levels of specific biomarkers, such as HER2 and Ki-67, will be assessed using immunohistochemistry (IHC) or quantitative PCR, with tumor tissue or blood samples collected at baseline and post-therapy.

    Measured: Within 4-6 months from enrollment, at the completion of surgery.

  7. AE rate

    Adverse event rate

    Measured: From enrollment to 12 months after the end of study treatment.

  8. Assessment of quality of life in patients using the FACT-B scale

    Quality of life refers to people's perception and experience of their physical state, mental function, social ability, and overall personal situation based on socioeconomic, cultural background and value orientation. FACT-B scale was used to assess patients before treatment, during treatment (from the first day of the third cycle, and every two cycles thereafter), and 30 days after treatment. Patients' quality of life was quantified by the proportion of changes in the score

    Measured: From enrollment to 12 months after the end of study treatment or the last follow-up visit.

Timeline

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

  1. First posted25 Feb 2025
  2. Study start1 Mar 2025
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2030 (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
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06843681
Sponsor's protocol ID
SYSKY-2024-746-01
Status last verified
Nov 2025
First submitted
26 Dec 2024
Last updated
28 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab combined with taxane neoadjuvant therapy in people with Breast Carcinoma in Situ, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 17 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 28 Nov 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast-conserving surgery rate after 4-6 cycles of treatment (time frame: From the start of neoadjuvant therapy to the completion of surgery (approximately 3-4 months after enrollment)). 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 NCT06843681.

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 28 Nov 2025.

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