Adaptive Therapy for Post-Second-Line Advanced Breast Cancer

June 5, 2025 updated by: Zhong-yu Yuan, Sun Yat-sen University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm
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
Drug: Gemcitabine, Vinorelbine, or Eribulin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Zhongyu Yuan, M.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2024

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

May 28, 2025

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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