Actively Recruiting

Phase 3
Age: 18Years - 75Years
FEMALE
NCT07088263

Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer

Led by Sun Yat-sen University · Updated on 2025-12-11

192

Participants Needed

1

Research Sites

144 weeks

Total Duration

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AI-Summary

What this Trial Is About

The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of advanced breast cancer progressive after standard treatment.

CONDITIONS

Official Title

Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Understands and voluntarily signs the informed consent form.
  • ECOG performance status of 0 or 1.
  • Expected survival longer than 3 months.
  • Histologically or cytologically confirmed advanced invasive breast cancer.
  • Histological type must be HR+/HER2- or HR-/HER2- as defined by specific hormone receptor and HER2 criteria.
  • Previous failure of first-line treatment for metastatic disease, including endocrine therapy with CDK4/6 inhibitors for HR+/HER2- or chemotherapy with PD-1 inhibitors or PARP inhibitors for TNBC as applicable.
  • At least one measurable lesion according to RECIST criteria.
  • Adequate organ function including bone marrow, kidney, liver, and heart.
  • Premenopausal women must use medically acceptable contraception during the study.
  • Compliance with the study protocol.
Not Eligible

You will not qualify if you...

  • Investigator judgment that medical conditions like uncontrolled hypertension or active infection would interfere with study participation or compliance.
  • Persistent toxicities from previous anti-tumor treatments not improved to Grade 2 or baseline.
  • Presence of neoplastic spinal cord compression or active brain metastases.
  • Significant fluid retention such as ascites or pleural effusion.
  • Uncontrolled infection requiring intravenous antibiotics.
  • Active or uncontrolled hepatitis B or C infection.
  • Uncontrolled or significant heart disease.
  • Suspected interstitial lung disease or non-infectious pneumonia.
  • Active autoimmune or inflammatory diseases, including inflammatory bowel disease.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510080

Actively Recruiting

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Research Team

Z

Zhong-yu Yuan, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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