Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer

NCT ID: NCT07088263

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2028-06-24

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.

Detailed Description

This is a prospective, multicenter phase Ⅲ clinical Trial. The objective of the study is to evaluate the efficacy and safety of adaptive chemotherapy vs. conventional chemotherapy in the treatment of advanced breast cancer progressive after standard treatment. 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 is designed to recruit up to 192 subjects.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy repeated every 28 days

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.

Group Type: EXPERIMENTAL

Gemcitabine, Vinorelbine, Eribulin, or Utidelone

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Gemcitabine, Vinorelbine, Eribulin, or Utidelone

Intervention Type: DRUG

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

Interventions

Gemcitabine, Vinorelbine, Eribulin, or Utidelone

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• 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

Sun Yat-sen University Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhong-yu Yuan, M.D.

Role: CONTACT

yuanzhy@sysucc.org.cn

China: +86 20 87343009

Facility Contacts

Zhong-yu Yuan, M.D.

Role: primary

yuanzhy@sysucc.org.cn

86-20-87343794

Other Identifiers

SYSUCC-081

Identifier Type: -

Identifier Source: org_study_id