Comparing treatment methods for locally advanced breast cancer

Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study

This study is testing whether starting with chemotherapy or surgery first is better for women with locally advanced breast cancer in helping them live longer and stay cancer-free.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06080620 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of two treatment sequences for locally advanced breast cancer (LABC): chemotherapy followed by surgery versus surgery followed by chemotherapy. Patients will be randomly assigned to one of the two groups, with the primary focus on comparing disease-free survival (DFS) rates. Secondary endpoints include overall survival (OS), five-year survival rates, and the incidence of local recurrence or distant metastasis. The study will enroll approximately 50 female patients aged 18-70 who meet specific inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-70 with newly diagnosed locally advanced breast cancer (stage IIIb - IIIc) who are eligible for surgical resection.

Not a fit: Patients who have previously undergone breast cancer-related surgery, radiotherapy, or chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment sequence for improving survival outcomes in patients with locally advanced breast cancer.

How similar studies have performed: Other studies have explored treatment sequences for breast cancer, but this specific comparison of surgery and chemotherapy sequences in LABC is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. 18-70 year old female
2. Patients with locally advanced breast cancer (stage IIIb - IIIc) first diagnosed;
3. Clinical diagnosis of breast cancer, or puncture pathology suggests breast cancer;
4. After evaluation by experienced clinical physicians, the patient's tumor has the possibility of surgical resection. Specific evaluation indicators include ultrasound assessment of the tumor not surrounding the axillary vein;
5. Accept treatment plans including surgery, radiotherapy, and chemotherapy;
6. Volunteer to participate in clinical research and sign an informed consent form;
7. Willing to undergo follow-up and complete quality of life (EQ-5D series scale and FACT-B scale) and postoperative psychological status (Anxiety/Depression Self Rating Scale) assessments;

Exclusion Criteria:

1. Patients under 18 years old or over 70 years old;
2. Those who have received breast cancer related surgery, radiotherapy or chemotherapy;
3. Those who are not expected to receive surgery, radiotherapy or chemotherapy related to breast cancer
4. History of other malignant tumors;
5. Pregnant or lactating women;
6. Accompanying active infection and fever;
7. Other serious diseases that may significantly affect clinical trial compliance, such as severe cardiopulmonary dysfunction, liver and kidney dysfunction, poorly controlled diabetes and mental illness.

Where this trial is running

Beijing

• Ying Xu — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Ying Xu

Conditions: Locally Advanced Breast Cancer, prognosis