Adaptive Therapy for Post-Second-Line Advanced Breast Cancer

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: HER2-negative Metastatic Breast Cancer
• Intervention / Treatment: Drug: Gemcitabine, Vinorelbine, or Eribulin

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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)	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

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

Study record dates

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: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine; Gemcitabine
• 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