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Completed

NCT Number: NCT06533722

Adaptive Therapy for Post-Second-Line Advanced Breast Cancer

The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of post-second-line metastatic breast cancer.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

This is a phase II, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of adaptive therapy in the treatment of post-second-line advanced breast cancer. The therapy regimen primarily including Gemcitabine, Vinorelbine, or Eribulin, will be selected by the investigator based on current guidelines, available treatments, and an assessment of the patient's clinical status, preferences, and financial situation. This study plans to recruit 10 subjects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Understands and voluntarily signs the informed consent form.
  • Minimum life expectancy 16 weeks.
  • Histologically or cytologically confirmed advanced invasive breast cancer.
  • Histological type: human epidermal growth factor receptor 2 (HER2) negative.
  • Prior failure of at least first-line treatment for metastatic disease.
  • At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
  • Premenopausal women must use medically acceptable contraception during the study.
  • Compliance with the study protocol.

Exclusion criteria

  • Pregnant or breast feeding.
  • Uncontrolled medical problems.
  • Evidence of active acute or chronic infection.
  • Hepatic, renal, cardiac, or bone marrow dysfunction.
  • Concurrent malignancy or history of other malignancy within the last five years.
  • Patients were unable or unwilling to comply with program requirements.
  • Concurrent use of any other anti-cancer therapy.

Treatment and study plan

Gemcitabine, Vinorelbine, or Eribulin

Drug

Gemcitabine Gemcitabine 1000 mg/m^2 IV on days 1 and 8, cycled every 33 days Vinorelbine 25 mg/m^2 IV on days 1 and 8, cycled every 33 days Eribulin 1.4 mg/m^2 IV on days 1 and 8, cycled every 33 days

Other names: chemotherapy

Primary outcomes

  1. progression-free survival (PFS)

    Time frame: 12 months

    The interval time from the date of initiation treatment after recruit to the date of the first documented disease progression or death due to any cause.

Secondary outcomes

  1. Occurrence and severity of adverse events (AEs)

    Time frame: 12 months

    Occurrence and severity of AEs by NCI-CTCAE v5. Changes in laboratory parameters (hematology and serum chemistry), vital signs and ECG parameters. Grade 3 or 4 abnormalities in serum chemistry laboratory parameters

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Phase II Study of the Efficacy and Safety of Adaptive Therapy for Metastatic Refractory Breast Cancer

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 1, 2024
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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