An Open-Label, Randomized, Multicenter, Phase II/III Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

Plain English Summary

A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer is a Phase 3 clinical trial sponsored by Shanghai Henlius Biotech studying HER2 + Breast Cancer. Tests a new combination of drugs to treat HER2-positive breast cancer that has come back or spread. For patients aged 18 and older with HER2-positive breast cancer who haven't had chemotherapy or HER2-targeted therapy before. Participation involves taking study drugs and having regular check-ups. Patients will be randomly assigned to one of the treatment groups. Alternative treatments include other HER2-targeted drugs like T-Dxd and Pertuzumab. The trial aims to enroll 706 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible patients must be 18 years or older, have HER2-positive breast cancer, and have not received prior chemotherapy or HER2-targeted therapy. Patients cannot have had a second cancer in the past 3 years, or certain heart or lung problems. Must be in good health overall, with no active infections or other serious illnesses. Women who are pregnant or breastfeeding are not eligible. This trial is studying HER2 + Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures, such as response rate and progression-free survival, will help determine if the treatment is effective for patients. The specific primary outcome measures are: Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1) (up to 26 months); Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1) (up to 37 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill a gap in treatment options for HER2-positive breast cancer, offering a new combination therapy that could improve outcomes. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets HER2 + Breast Cancer, where improved treatment options are needed.

Investor Insight

The large market size and competitive landscape suggest a high probability of approval, making this an attractive investment opportunity. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 706 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have HER2-positive breast cancer and if you are eligible for this study. Participation involves taking study drugs and having regular check-ups at the hospital. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 706 participants

Interventions

• DRUG: HLX87 + HLX22 — HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. HLX22 is a novel monoclonal antibody targeting HER2 .
• DRUG: HLX87 + Pertuzumab — HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan
• DRUG: T-Dxd + Pertuzumab — T-Dxd is a HER2-targeted ADC
• DRUG: THP — Pertuzumab+ Trastuzumab+Docetaxel

Primary Outcomes

• Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1) (up to 26 months)
• Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1) (up to 37 months)

Secondary Outcomes

• ● ORR (assessed by the investigator as per RECIST v1.1) (up to 26 months)
• ● PFS (assessed by the investigator as per RECIST v1.1) (up to 37 months)
• Second progression-free survival (PFS2) (up to 37 months)
• Overall survival (OS) (up to 37 months)
• Incidence and severity of adverse events (AEs) (up to 37 months)

Full Eligibility Criteria

Inclusion Criteria:

* 1\. Have a full understanding of the study content, and sign the informed consent form (ICF); 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Histopathologically confirmed breast cancer that meets the following criteria:

  1. Advanced or metastatic breast cancer.
  2. HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.
  3. 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).

  5\. At least one measurable lesion as assessed by central imaging according to RECIST v1.1.

  7\. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1.

  8\. Life expectancy ≥ 12 weeks. 9. Adequate organ functions

Exclusion Criteria:

* 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).

  3\. Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors.

  4\. Uncontrolled or significant cardiovascular diseases 5. Cerebrovascular accidents within 6 months prior to the first dose of study drugs.

  6\. ILD/pneumonitis, or suspected ILD/pneumonitis or clinically significant lung-specific intercurrent illness .

  7\. Active infection . 8. Presence of spinal cord compression or clinically symptomatic central nervous system metastases.

  9\. Residual toxicity from previous anti-tumor therapy that has not resolved to Grade ≤ 1 as per NCI-CTCAE V6.0 or baseline level (except for alopecia).

  10\. Presence of active tuberculosis. 11. Have received treatment with live attenuated vaccines within 30 days prior to the first dose of study drugs.

  12\. Known history of severe allergic reaction to macromolecular protein preparations, hypersensitivity to the ingredient of the investigational products, or severe hypersensitivity to any excipient of the study drugs.

  13\. Known history of abuse of psychotropic drugs or drug addiction. 14. Pregnant or lactating women.

Trial Locations

• Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

Frequently Asked Questions

Related Conditions

• Breast cancer, HER2-positive breast cancer, metastatic breast cancer, recurrent breast cancer, oncology

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