Nab-paclitaxel with carboplatin versus nab-paclitaxel with epirubicin before surgery for triple-negative breast cancer

Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

This trial will test whether adding carboplatin or adding epirubicin to nab-paclitaxel before surgery works better for women with triple-negative breast cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 520 (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: NCT04138719 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label, randomized Phase 2 comparison of two neoadjuvant chemotherapy combinations given before surgery for triple-negative breast cancer. About 520 eligible women with primary TNBC and tumors larger than 2 cm will be randomly assigned to receive nab-paclitaxel plus carboplatin or nab-paclitaxel plus epirubicin. The study will monitor tumor response, surgical outcomes, and safety, with collection of blood samples and tumor tissue at baseline and blood at surgery. Results will be used to compare the effectiveness and tolerability of the two regimens to guide clinical choices for preoperative treatment.

Who should consider this trial

Good fit: Women aged 18–70 with histologically confirmed primary invasive triple-negative breast cancer, a measurable tumor >2 cm, ECOG 0–1, adequate heart, liver, kidney and bone marrow function, and willingness to provide tissue and blood samples are ideal candidates.

Not a fit: Patients with hormone receptor–positive or HER2‑positive disease, metastatic cancer, significant organ dysfunction (including LVEF <55%), or those outside the age range are unlikely to benefit from joining this protocol.

Why it matters

Potential benefit: If successful, the better regimen could increase tumor shrinkage before surgery and help more women undergo breast-conserving operations.

How similar studies have performed: Previous trials have shown that adding carboplatin to taxane-based neoadjuvant regimens can increase pathological response rates in TNBC and anthracyclines like epirubicin are established agents, but direct randomized head-to-head comparisons of these exact combinations are less common.

Eligibility criteria

Inclusion Criteria:

1. Females with age between 18 to 70 years old;
2. Histologically confirmed primary invasive breast cancer;
3. Histologically confirmed triple negative breast cancer;
4. Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
5. Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
6. Have at least one measurable lesion as per the RECIST criteria (version 1.1);
7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
8. LVEF≥55%；
9. Bone marrow function：neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L);
10. 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;
11. Patients had good compliance with the planned treatment, understood the research process and written informed consent.

Exclusion Criteria:

1. Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
2. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
3. Patients with severe systemic infection or other serious diseases;
4. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
5. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
6. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
7. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
8. 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 Breast Cancer; Triple-negative Breast Cancer; Nab-paclitaxel; Carboplatin; Epirubicin