A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

Sponsor
RemeGen Co., Ltd.
Study ID
NCT04400695
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • RC48-ADC — DRUG
    RC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks
  • Paclitaxel Injection — DRUG
    Administered according to label, as one option for Physician's Choice (determined before randomization)
  • Docetaxel Injection — DRUG
    Administered according to label, as one option for Physician's Choice (determined before randomization)
  • Vinorelbine Tartrate Injection — DRUG
    Administered according to label, as one option for Physician's Choice (determined before randomization)
  • Capecitabine Tablets — DRUG
    Administered according to label, as one option for Physician's Choice (determined before randomization)

Study Details

This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis.

Key Dates

Start date
Sep 29, 2020
Status verified
Dec 2023
Primary completion
Jun 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
366 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RC48-ADC
    RC48-ADC common name：Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection Dosage form：Lyophilized powder injection specification：60 mg / piece Medication plan：Every 2 weeks Expiration date：18 months HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis.
  • Active Comparator: Physician's Choice
    Physician's Choice: HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis. Physician's choice from the following options: Paclitaxel Injection Docetaxel Injection Vinorelbine Tartrate Injection Capecitabine Tablets

Primary Outcome Measure

Progression-free survival (PFS), evaluated by an independent efficacy evaluation committee [ Time Frame: within approximately 3 years ]

Central Contacts

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