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AzTrials

HER2-positive Early Breast CancerPhase 2TAYLORNCT07340398

Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer

A Phase 2 study testing Nab paclitaxel, Carboplatin and Trastuzumab in people with HER2-positive Early Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
HER2-positive Early Breast Cancer
What is being tested?
Nab paclitaxel, Carboplatin and Trastuzumab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
25 Dec 2025to 1 Jan 2031
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤75 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Primary tumor size >1 cm.
  • Histologically confirmed invasive breast cancer, clinically staged as:
  • Stage I (T1cN0M0)
  • Stage II (T1cN1M0, T2N0-1M0 or T3N0M0)
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  • Stage III (T2N2-3M0, T3N1-3M0, or T4N0-3M0)
  • HER2-positive status: IHC 3+ or IHC 2+ with positive ISH.
  • Adequate major organ function:
  • Hematology (no transfusion or hematopoietic growth factors, e.g., G-CSF, within 14 days):
  • Hemoglobin ≥100 g/L
  • Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
  • Platelet count ≥100 × 10⁹/L
  • Biochemistry:
  • Total bilirubin ≤1.5 × ULN
  • ALT and AST ≤1.5 × ULN; ALP ≤2.5 × ULN
  • BUN and creatinine ≤1.5 × ULN
  • Cardiac function: LVEF ≥55% by echocardiography
  • Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study and for 8 weeks after the last dose.
  • Voluntary written informed consent and willingness to comply with study procedures and follow-up.

Who cannot join

  • Prior anti-tumor therapy for breast cancer, including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy.
  • Concurrent administration of any other anti-tumor treatment.
  • Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
  • Breast cancer not confirmed histologically.
  • History of other malignancy within the past 5 years, except successfully treated cervical carcinoma in situ.
  • Severe dysfunction of major organs (heart, liver, kidney).
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  • Conditions affecting oral drug administration or absorption, e.g., inability to swallow, chronic diarrhea, or intestinal obstruction.
  • Participation in another investigational drug trial within 4 weeks prior to enrollment.
  • Known hypersensitivity to study drug components; history of immunodeficiency (HIV positive, active HCV, active hepatitis B, other congenital/acquired immunodeficiency) or prior organ transplantation.
  • History of clinically significant cardiac disease, including:
  • Arrhythmia requiring medication
  • Myocardial infarction
  • Heart failure
  • Other cardiac conditions deemed unsuitable for study participation by the investigator
  • Pregnant or breastfeeding women, or women of childbearing potential who test positive at baseline or are unwilling to use effective contraception throughout the study.
  • Any condition that, in the investigator's judgment, poses serious risk to patient safety or may interfere with study completion (e.g., uncontrolled severe hypertension, uncontrolled diabetes, active infection).
  • History of neurological or psychiatric disorders (e.g., epilepsy or dementia) or any other condition the investigator considers incompatible with study participation.

Trial locations and contacts

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

Yiding Chen contact

15868131018

ydchen@zju.edu.cn

Yunxiang Zhou contact

yxzhou@zju.edu.cn

China1 site, 1 recruiting

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou

    Yunxiang Zhou, 15868131018, yxzhou@zju.edu.cn

    Yiding Chen

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer: A Response-Guided Phase II Study (TAYLOR)

This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After receiving neoadjuvant dual-HER2-targeted therapy with chemotherapy, patients are evaluated for their treatment response. Those achieving an adequate response continue the therapy, whereas patients with a suboptimal response transition to an intensified investigational regimen incorporating novel targeted agents. This adaptive approach aims to optimize pathologic response, minimize unnecessary toxicity, and explore more effective treatment options for individuals with insufficient benefit from conventional neoadjuvant therapy.

Read the detailed description

This is a prospective, response-guided, phase II study designed to evaluate individualized neoadjuvant treatment strategies in patients with HER2-positive early breast cancer. The study incorporates an adaptive treatment algorithm based on early response assessment to an initial neoadjuvant dual HER2-targeted therapy combined with chemotherapy, with the aim of optimizing therapeutic efficacy while minimizing unnecessary treatment-related toxicity.

All eligible patients initially receive neoadjuvant dual HER2-targeted therapy combined with chemotherapy according to the study protocol. Following completion of a predefined initial treatment phase, tumor response is systematically assessed using standardized clinical and radiologic criteria.

Patients who achieve an adequate response continue the same neoadjuvant treatment to complete the planned course of therapy. In contrast, patients demonstrating a suboptimal response are assigned to an intensified investigational neoadjuvant strategy. The escalation regimens include either trastuzumab-rezetecan in combination with pertuzumab or a pyrotinib-based multi-agent regimen incorporating chemotherapy and HER2-directed therapy. Treatment selection and administration follow protocol-specified criteria and schedules.

The response-guided escalation strategy is intended to address the unmet clinical need of patients who derive insufficient benefit from standard neoadjuvant dual HER2-targeted therapy combined with chemotherapy. By selectively intensifying treatment only in patients with suboptimal response, this study seeks to enhance pathologic response rates while avoiding overtreatment in patients who respond adequately to initial therapy.

Primary and secondary objectives focus on evaluating pathologic response outcomes, safety and tolerability of the adaptive treatment strategies, and feasibility of response-guided treatment modification in the neoadjuvant setting. Exploratory analyses will assess potential biomarkers associated with treatment response and resistance, providing insights to inform future personalized neoadjuvant treatment approaches in HER2-positive early breast cancer.

What participants receive

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

  • Nab paclitaxelDrug

    Nab paclitaxel

  • CarboplatinDrug

    carboplatin

  • TrastuzumabDrug

    trastuzumab

  • PertuzumabDrug

    pertuzumab

  • SHR-A1811Drug

    Also called Trastuzumab-rezetecan

    a HER2-targeted antibody-drug conjugate (ADC)

  • PyrotinibDrug

    Pyrotinib: an oral irreversible pan-HER tyrosine kinase inhibitor (TKI).

Study groups in NCT07340398
Study groupRoleWhat they receive
nab-PCbHPyExperimentalNot described
Receives: Drug: Nab paclitaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pyrotinib
SHR-A1811+PExperimentalNot described
Receives: Drug: Pertuzumab; Drug: SHR-A1811

What is being measured

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

  1. Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0

    The tpCR rate is defined as the proportion of participants with no residual invasive cancer cells in both the breast primary tumor site (residual in situ cancer cells are permitted) and all sampled axillary lymph nodes.

    Measured: 18 weeks

Secondary outcomes (4)

  1. Breast Pathological Complete Response (bpCR) Rate: ypT0/Tis

    The bpCR rate is defined as the proportion of participants with no residual invasive cancer cells in the breast primary tumor site (residual in situ cancer cells are permitted).

    Measured: 18 weeks

  2. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants with a complete or partial response.

    Measured: 18 weeks

  3. Event-Free Survival (EFS)

    EFS is defined as the time from randomization to any of the following events: precludes surgery, local or distant recurrence, second primary malignancy, or death due to any cause.

    Measured: Approximately five years

  4. Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product, temporally associated with study intervention, without presumption of causality.

    Measured: Approximately three years

Timeline

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

  1. First posted14 Jan 2026
  2. Study start25 Dec 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion1 Jan 2031 (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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07340398
Sponsor's protocol ID
2025-1587
Acronym
TAYLOR
Status last verified
Dec 2025
First submitted
6 Jan 2026
Last updated
21 Jan 2026
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 Nab paclitaxel, Carboplatin and Trastuzumab in people with HER2-positive Early Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 20 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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?

Contact Yiding Chen (15868131018, ydchen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0 (time frame: 18 weeks). 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 NCT07340398.

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 21 Jan 2026.

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