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A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer

ConditionEarly or Locally Advanced HER2-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai JMT-Bio Inc.

About this trial

This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in the experiment and sign the informed consent;

Aged >= 18 years;

Histologically and cytologically confirmed primary invasive carcinoma of the breast with early (T2-3, N0-1, M0) or locally advanced stage (T2-3, N2-3, M0; T4, any N, M0) (AJCC 8th Edition);

ECOG PS 0-1;

Disqualifiers

Inflammatory or bilateral breast cancer;

History of non-breast malignancies within the 3 years prior to study entry, except for carcinoma in situ of the cervix or breast, and basal cell and squamous cell carcinomas of the skin, etc.;

The researchers determine that there are contraindications for breast cancer surgery;

Participants who underwent primary lumpectomy and/or axillary lymph node dissection biopsy prior to randomization (except for diagnostic biopsy of primary breast cancer or surgery for benign breast tumors);

Trial design

Design model

Parallel

Treatments tested in this trial

  • KN026

    Drug

    KN026

  • HB1801

    Drug

    HB1801

  • Pertuzumab

    Drug

    Pertuzumab

  • Trastuzumab

    Drug

    Trastuzumab

  • Docetaxel

    Drug

    Docetaxel

  • Carboplatin

    Drug

    Carboplatin

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: KN026 plus HB1801 ± CarboplatinExperimental treatment 2 interventions
Group B: Pertuzumab and trastuzumab plus docetaxel ± CarboplatinActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

tpCR (BIRC, AJCC 8th)

tpCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

EFS (INV, RECIST v1.1)

EFS event was defined as the time between the data of randomization and the date on which any of the following events: disease progression; breast cancer recurrence; death attributable to any cause.

Time frame
Through study completion, an average of 1 year
2

tpCR (INV, AJCC 8th)

Description: tpCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

Time frame
Through study completion, an average of 1 year
3

bpCR (BIRC and INV, AJCC 8th)

bpCR (ypT0/Tis) is defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.

Time frame
Through study completion, an average of 1 year
4

ORR (INV, RECIST v1.1)

Time frame
After 2 cycles of chemotherapy (21 days as 1 cycle).

Other outcomes

Sponsors and contacts

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

Shanghai JMT-Bio Inc.

Lead sponsor

Source ClinicalTrials.gov
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