Adaptive Therapy for Post-Second-Line Advanced Breast Cancer

NCT06533722 | Completed Phase 2 DMC

• 1 other identifier: SYSUCC-049
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-negative Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Occurrence and severity of adverse events (AEs)

  12 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

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

Interventions

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

Also known as: chemotherapy

Treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

Gemcitabine; Vinorelbine; eribulin; Drug Therapy

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Zhongyu Yuan, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: August 4, 2024
• Primary Completion: September 20, 2024
• Study Completion: May 28, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)