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A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

ConditionHER2 + Breast Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Henlius Biotech

About this trial

The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Advanced or metastatic breast cancer.

HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.

Positive or negative for hormone receptor HR (including estrogen receptor [ER] and progesterone receptor [PgR]) as determined by the central laboratory 4. No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer (1 line of endocrine therapy is allowed).

Disqualifiers

1. History of a second malignancy within 3 years prior to signing the ICF. 2. Previous use of doxorubicin with a concentration of > 360 mg/m2 (or equivalent).

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX87 + HLX22

    Drug

    HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. HLX22 is a novel monoclonal antibody targeting HER2 .

  • HLX87 + Pertuzumab

    Drug

    HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan

  • T-Dxd + Pertuzumab

    Drug

    T-Dxd is a HER2-targeted ADC

  • THP

    Drug

    Pertuzumab+ Trastuzumab+Docetaxel

Treatment groups

706 Participants
are divided into 4 treatment groups
Group A: HLX87+ HLX22Experimental treatment 1 intervention
Group B: HLX87+ PertuzumabExperimental treatment 1 intervention
Group C: T-Dxd + PertuzumabActive comparator 1 intervention
Group D: THPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1)

Time frame
up to 26 months
2

Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1)

Time frame
up to 37 months

Secondary outcomes

1

● ORR (assessed by the investigator as per RECIST v1.1)

Time frame
up to 26 months
2

● PFS (assessed by the investigator as per RECIST v1.1)

Time frame
up to 37 months
3

Second progression-free survival (PFS2)

Time frame
up to 37 months
4

Overall survival (OS)

Time frame
up to 37 months

Other outcomes

Sponsors and contacts

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

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov
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