Comparing two nab‑paclitaxel combinations for advanced triple‑negative breast cancer

Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

This test compares nab‑paclitaxel with carboplatin versus nab‑paclitaxel with capecitabine in people with advanced triple‑negative breast cancer who have had up to one prior systemic treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 414 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT04159142 on ClinicalTrials.gov

What this trial studies

This is a multi‑center, open‑label Phase 2 trial that randomizes patients with advanced triple‑negative breast cancer to receive either nab‑paclitaxel plus carboplatin or nab‑paclitaxel plus capecitabine. Participants must have up to one prior line of systemic therapy for metastatic disease and at least one measurable lesion by RECIST 1.1. Treatment includes the combination phase and allows capecitabine maintenance after combination chemotherapy where applicable. The trial monitors safety and effectiveness outcomes such as response rates, progression‑free survival, and adverse events.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed triple‑negative advanced or metastatic breast cancer, ECOG performance status 0–1, measurable disease, and no more than one prior systemic treatment are ideal candidates.

Not a fit: Patients with significant heart disease (NYHA class II or worse), poor organ function, or more than one prior line of metastatic therapy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify a more effective and tolerable chemotherapy combination that prolongs disease control for people with advanced TNBC.

How similar studies have performed: Previous studies have shown activity for both platinum agents and capecitabine in TNBC and for nab‑paclitaxel combinations, but direct head‑to‑head comparisons in this exact setting are limited.

Eligibility criteria

Inclusion Criteria:

1. Females with age between 18 to 70 years old;
2. Histologically confirmed triple negative breast cancer;
3. No more than one-line prior treatment for locally advanced or metastatic breast cancer;
4. Have at least one measurable lesion as per the RECIST criteria (version 1.1);
5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
6. Patients with life expectancy of at least 3 months;
7. Bone marrow function：neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L);
8. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
9. Patients had good compliance with the planned treatment, understood the research process and written informed consent.

Exclusion Criteria:

1. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
2. Brain metastasis;
3. Recurrence or metastasis within 6 months after capecitabine withdrawal;
4. Recurrence or metastasis within 6 months after platinum withdrawal;
5. Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;
6. Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;
7. Patients who had Grade 2 or above Peripheral neuropathy;
8. Patients with severe systemic infection or other serious diseases;
9. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
10. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
11. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
12. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
13. The researchers considered the patients who were not suitable for enrollment.

Where this trial is running

Shijiazhuang, Hebei

• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Study coordinator: Cuizhi Geng, M.D.

Conditions Triple Negative Breast Cancer; Nab-paclitaxel; Carboplatin; Capecitabine; Maintenance therapy