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Breast Cancer Early Stage Breast Cancer (Stage 1-3)Phase 2NCT06927180

SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC

A Phase 2 study testing SHR-A1811, Pertuzumab and Albumin-Paclitaxel in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Henan Cancer Hospital 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

The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
SHR-A1811, Pertuzumab and Albumin-Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
16 Apr 2025to 1 Dec 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-70 years old, ECOG 0-1 point.
  • Clinical T2-T4, with any LN, M0.
  • HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization [FISH] in the pathological test/review of the primary focus conducted by the Pathology Department of the Research Center Hospital).
  • Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of randomization.
  • Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy：Absolute value of neutrophil count ≥ 1.5 × 10^9/L; Hemoglobin ≥ 90g/L; Platelet count ≥ 100 × 10^9/L; Total bilirubin≤1.5 ULN (upper limit of normal value); Creatinine≤1.5 × ULN; AST/ALT ≤ 2.5 × ULN.
  • Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 50%).
  • Women of childbearing age tested negative for serum pregnancy test 7 days before randomization.
  • Sign an informed consent form.

Who cannot join

  • Stage IV (metastatic) breast cancer.
  • Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.
  • The patient has a second primary malignant tumor, except for fully treated skin cancer.
  • The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
  • The presence of uncontrolled cardiovascular and cerebrovascular disease, including (but not limited to) any of the following within the 6 months prior to the first dose: congestive heart failure (NYHA III or IV), myocardial infarction or cerebral infarction, pulmonary embolism, unstable angina, or arrhythmia requiring treatment at the time of screening; Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy); A clinically significant history of prolonged QTc, grade II type II atrioventricular block or grade III atrioventricular block or QTc interphase (F method) > 470 msec (female); Atrial fibrillation (EHRA grade ≥2b); Unmanageable hypertension, which the investigators judged unsuitable for study participation.
  • Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.
  • Individuals with a known history of allergies to the drug components of this protocol;
  • Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.

Trial locations and contacts

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

Zhenzhen Liu contact

86+13603862755

liuzhenzhen73@126.com

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Recruiting

Other trials in China

About this study

Official title: SHR-A1811 Plus Pertuzumab in Combination With or Without Albumin-paclitaxel as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Randomized, Open-label, Phase II Trial.

The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are:

  • Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment?
  • Is the safety of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? Researchers will compare SHR-A1811+pertuzumab or SHR-A1811+pertuzumab+albumin-paclitaxel to TCbHP to see if SHR-A1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced HER2-positive breast cancer.
Read more

Subjects will be randomly assigned 1:1:1 to：

  • cohort 1：SHR-A1811 combined with pertuzumab for 6 cycles;
  • cohort 2：SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles;
  • cohort 3：TCbHP (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Being tested
SHR-A1811, Pertuzumab, Albumin-Paclitaxel, Docetaxel, Carboplatin
Keywords
Breast Cancer, HER2-positive Breast Cancer, pathologic complete response, SHR-A1811, Pertuzumab, Albumin-Paclitaxel
Medical subject headings
Breast Neoplasms, Pathologic Complete Response

What participants receive

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

Study groups in NCT06927180
Study groupRoleWhat they receive
Cohort 1：SHR-A1811+PertuzumabExperimentalParticipants will receive SHR-A1811+Pertuzumab for 6 cycles.
Receives: Drug: SHR-A1811; Drug: Pertuzumab
Cohort 2：SHR-A1811+Pertuzumab+Albumin-PaclitaxelExperimentalParticipants will receive SHR-A1811+Pertuzumab+Albumin-Paclitaxel for 6 cycles.
Receives: Drug: SHR-A1811; Drug: Pertuzumab; Drug: Albumin-Paclitaxel
Cohort 3：TCbHPActive comparatorParticipants will receive Docetaxel +Carboplatin +Trastuzumab +Pertuzumab for 6 cycles.
Receives: Drug: Pertuzumab; Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab

What is being measured

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

  1. Pathological complete response rate (pCR rate)

    After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)

    Measured: After surgery（within 1 month）

Secondary outcomes (4)

  1. Invasive Disease Free Survival of 5 years

    5-year Invasive Disease-Free Survival was defined as patients who did not experience regional, contralateral or distant recurrence, or dies during a follow-up period of at least 5 years from the date of surgery.

    Measured: 5-year

  2. Event-Free Survival of 5 years

    5-year Event-Free Survival was defined as patients who did not experience disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or dies during a follow-up period of at least 5 years after treatment.

    Measured: 5-year

  3. 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.

    Measured: During neoadjuvant therapy before surgery（within 6 months）

  4. Adverse Events rate

    Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0

    Measured: 2-year

Timeline

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

  1. First posted15 Apr 2025
  2. Study start16 Apr 2025
  3. Primary completion1 May 2029 (estimated)
  4. Study completion1 Dec 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
Randomised
Intervention model
Parallel groups
Model description
Patients who meet the inclusion criteria were randomly divided into SHR-A1811+pertuzumab and SHR-A1811+pertuzumab+albumin-paclitaxel and TCbHP group in a 1:1:1 ratio.
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06927180
Sponsor's protocol ID
2024-543
Status last verified
Jun 2025
First submitted
4 Mar 2025
Last updated
23 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-A1811, Pertuzumab and Albumin-Paclitaxel in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Henan Cancer Hospital 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 8 inclusion and 8 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 23 Jun 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?

Contact Zhenzhen Liu (86+13603862755, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (pCR rate) (time frame: After surgery（within 1 month）). 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 NCT06927180.

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 23 Jun 2025.

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