NCT04159142 Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
| NCT ID | NCT04159142 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hebei Medical University Fourth Hospital |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 414 participants |
| Start Date | 2019-11-20 |
| Primary Completion | 2026-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 414 participants in total. It began in 2019-11-20 with a primary completion date of 2026-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Zefei Jiang, M.D.
STUDY CHAIR
Beijing 302 Hospital
Frequently Asked Questions
Who can join the NCT04159142 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04159142 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04159142 currently recruiting?
Yes, NCT04159142 is actively recruiting participants. Contact the research team at gengcuizhi@hotmail.com for enrollment information.
Where is the NCT04159142 trial being conducted?
This trial is being conducted at Shijiazhuang, China.
Who is sponsoring the NCT04159142 clinical trial?
NCT04159142 is sponsored by Hebei Medical University Fourth Hospital. The principal investigator is Zefei Jiang, M.D. at Beijing 302 Hospital. The trial plans to enroll 414 participants.
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