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

ConditionBreast Cancer Early Stage Breast Cancer (Stage 1-3)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHenan Cancer Hospital

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1811

    Drug

    an anti-HER2 antibody-drug conjugate (ADC)

  • Pertuzumab

    Drug

    Pertuzumab

  • Albumin-Paclitaxel

    Drug

    Nab paclitaxel

  • Docetaxel

    Drug

    Docetaxel

  • Carboplatin

    Drug

    Carboplatin

  • Trastuzumab

    Drug

    Trastuzumab

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Cohort 1：SHR-A1811+PertuzumabExperimental treatment 2 interventions
Group B: Cohort 2：SHR-A1811+Pertuzumab+Albumin-PaclitaxelExperimental treatment 3 interventions
Group C: Cohort 3：TCbHPActive comparator 4 interventions

Trial outcomes

Primary outcomes

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)

Time frame
After surgery（within 1 month）

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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

Time frame
2-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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