Adaptive Therapy for Post-Second-Line Advanced Breast Cancer

NCT ID: NCT06533722

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-04
• Study Completion Date: 2025-05-28

Brief Summary

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.

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.

Conditions

HER2-negative Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Gemcitabine, Vinorelbine, or Eribulin

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

chemotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhong-yu Yuan

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhongyu Yuan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSUCC-049

Identifier Type: -

Identifier Source: org_study_id