Personalized Treatment vs Physician's Choice for Breast Cancer

Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer

Recruiting Phase 3 Interventional Study
Breast Cancer Refractory Breast Carcinoma
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
Prevention
Participants needed
302 (estimated)
Sponsor
Sun Yat-sen University · Other
Who this trial is looking for

This trial is looking for adults with advanced or metastatic breast cancer who have received multiple treatments but no longer respond to standard therapies. Participants will receive either a personalized treatment based on their tumor's characteristics or the usual treatment options chosen by their doctor.

Are You a Good Fit for This Trial?
Rules you out Heart failureActive pulmonary tuberculosisActive hepatitis

You may be able to join if

  • I am over 18 years old.
  • I have been diagnosed with breast cancer that has spread.
  • I have received at least 2 prior treatments for my cancer.
  • I have a life expectancy of at least 3 months.
  • I have measurable tumors that can be evaluated.
  • I do not have serious organ problems.
  • I can follow the study visit schedule.
  • I consent to using effective birth control if I am of childbearing age.

You may not be able to join if

  • I am currently participating in another clinical study.
  • I have had recent treatment for my cancer within the last 4 weeks.
  • I have another active cancer that requires treatment.
  • I have a history of organ transplantation.
  • I have severe heart problems.
  • I am pregnant or breastfeeding.
  • I have untreated active hepatitis.
  • I have a known allergy to any study drug.

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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About This Trial

This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment (OGPT)versus treatment of physician's choice (TPC) in previously treated refractory breast cancer.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form 2. Aged over 18 years old, regardless of gender; 3. Locally advanced or metastatic breast cancer confirmed by histopathology; 4. Received ≥2 previous lines of anti-tumor treatment and developed resistance to standard …
Contacts

Yanxia Shi

020-87343368

shiyx@sysucc.org.cn

CONTACT