JSKN003 vs Chemotherapy for Advanced Breast Cancer

JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Recruiting Phase 3 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
Who this trial is looking for

This trial is looking for adults with advanced breast cancer who have not responded to previous treatments. Participants will receive either the new drug JSKN003 or a chemotherapy chosen by their doctor.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with advanced breast cancer.
  • I have already received at least one previous chemotherapy treatment.
  • I have a measurable cancer lesion outside the brain.
  • I can provide tumor samples for testing.
  • I am willing to use effective contraception if I can become pregnant.
  • I am expected to live for at least 3 more months.

You may not be able to join if

  • I have untreated brain or spinal cancer.
  • I only have skin cancer lesions.
  • I have had another type of cancer in the past 5 years.
  • I have ongoing pneumonia or lung disease.
  • I cannot swallow or absorb medication properly.
  • I have a history of autoimmune disease.
  • I have uncontrolled other health problems.
  • I have had severe allergic reactions to medications.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial
This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemothera…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1\. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form. 2\. The subject ≥ 18 years old on the day of signing the informed consent form, male or female. 3\. Unresectable locally recurrent or metastatic b…
Contacts

Erwei Song

020-81332507

songew@mail.sysu.edu.cn

CONTACT

Jiong Wu

02164175590

wujiong1122@vip.sina.com

CONTACT