Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer

NCT07088263 | Recruiting Phase 3 DMC

• 1 other identifier: SYSUCC-081
• Study Type: interventional
• Target: 192
• 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 advanced breast cancer progressive after standard treatment.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  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

Study Arms (2)

Chemotherapy repeated every 28 days

EXPERIMENTAL

Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone. Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 28 days.

Drug: Gemcitabine, Vinorelbine, Eribulin, or Utidelone

Chemotherapy repeated every 21 days

ACTIVE COMPARATOR

Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone. Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 21 days.

Drug: Gemcitabine, Vinorelbine, Eribulin, or Utidelone

Interventions

Gemcitabine, Vinorelbine, Eribulin, or Utidelone DRUG

Gemcitabine, Vinorelbine, Eribulin, or Utidelone is recieved every 28 days. The chemotherapy interval is one cycle every 28 days.

Chemotherapy repeated every 21 days; Chemotherapy repeated every 28 days

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.
• ECOG PS of 0 or 1.
• Expected survival: \>3 months
• Histologically or cytologically confirmed advanced invasive breast cancer.
• Histological type: HR+/HER2- or HR-/HER2-. HR positivity is defined as ER and/or PR expression in ≥1% of tumor cells by IHC. HER2 negativity is defined according to the ASCO-CAP HER2 guidelines: IHC intensity of 0 or 1+, or IHC intensity of 2+ with negative in situ hybridization results.
• Previous failure of first-line treatment for metastatic disease. For HR+/HER2- patients: at least received endocrine therapy combined with CDK4/6 inhibitors. TNBC patients at least received chemotherapy combined with PD-1 inhibitors (if PD-L1 CPS ≥1), or PARP inhibitor treatment (if germline BRCA mutations), except for TNBC patients with known germline BRCA mutations whom the attending physician deems them unable or unsuitable for PARP inhibitor treatment.
• 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:

• The investigator considers that the presence of the following factors would be unfavorable to the subject's participation in the study or may affect protocol compliance, such as uncontrolled hypertension, persistent or active infection, etc.
• Persistent toxicities caused by previous anti-tumor treatment that have not improved to ≤ Grade 2 or baseline levels.
• Neoplastic spinal cord compression or active brain metastases.
• Significant third-space fluid retention (e.g., ascites or pleural effusion).
• Uncontrolled infection requiring treatment with intravenous antibiotic.
• Active or uncontrolled hepatitis B or hepatitis C virus infection.
• Uncontrolled or significant heart disease.
• Suspected ILD/non-infectious pneumonia.
• Active autoimmune disease or inflammatory disease (including inflammatory bowel disease.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Vinorelbine; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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

Central Study Contacts

Zhong-yu Yuan, M.D.

CONTACT

China: +86 20 87343009; yuanzhy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 24, 2027
• Study Completion (Estimated): June 24, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)