NCT04159142RecruitingPhase 2
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of 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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 414 (estimated)
- First submitted
- 23 Oct 2019
- Start date
- 20 Nov 2019
- Primary completion date
- 20 Jun 2026
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04159142
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 414
- From 20 Nov 2019 to the primary completion date, 20 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
Other illness
- Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
- Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;
- Patients with severe systemic infection or other serious diseases;
- Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
- Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
Lab values
- Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;
Age
- Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
Other
- Brain metastasis;
- Recurrence or metastasis within 6 months after capecitabine withdrawal;
- Recurrence or metastasis within 6 months after platinum withdrawal;
- Patients who had Grade 2 or above Peripheral neuropathy;
- The researchers considered the patients who were not suitable for enrollment.
Who the study is looking for
- Females with age between 18 to 70 years old;
- Histologically confirmed triple negative breast cancer;
- No more than one-line prior treatment for locally advanced or metastatic breast cancer;
- Have at least one measurable lesion as per the RECIST criteria (version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
- Patients with life expectancy of at least 3 months;
- Bone marrow function：neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L);
- 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;
- Patients had good compliance with the planned treatment, understood the research process and written informed consent.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.