NCT04136782 Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer
| NCT ID | NCT04136782 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shengjing Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2021-07-19 |
| Primary Completion | 2025-11-30 |
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.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 110 participants in total. It began in 2021-07-19 with a primary completion date of 2025-11-30.
⚠ 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
To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.
Eligibility Criteria
Inclusion Criteria: * patients developing breast cancer as confirmed by X-ray examination, cancer tissue negative for estrogen receptor, progesterone receptor and HER2, and tumor stage II-III; * estimated survival \> 3 months; * presence of clinically measurable lesions; * Karnofsky functional status score ≥ 70; * normal routine blood test results, normal liver and kidney function, and near normal electrocardiographic manifestations; * age at 18-70 years. Exclusion Criteria: * stage IV breast cancer patients with bone metastasis or other distant metastasis; * severe renal insufficiency; * older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy; * those who have received antineoplastic therapy; * those who have received neoadjuvant chemotherapy but fail in 2 cycles of neoadjuvant chemotherapy and switch to other regimens or terminate chemotherapy; * those with history of other malignant tumors; * those with severe heart, liver, and kidney organ dysfunction or poor health who cannot tolerate chemotherapy, or those who cannot tolerate chemotherapy and switch to other therapeutic regimens; * those with mental and nervous system diseases who cannot comply with treatment; * those with dexamethasone intolerance or those who are highly allergic to any drug in neoadjuvant chemotherapy; * pregnant or lactating women; * those who are participating in other trials.
Contact & Investigator
Caigang Liu, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Shengjing Hospital
Frequently Asked Questions
Who can join the NCT04136782 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying 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 NCT04136782 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04136782 currently recruiting?
Yes, NCT04136782 is actively recruiting participants. Contact the research team at jadegx@163.com for enrollment information.
Where is the NCT04136782 trial being conducted?
This trial is being conducted at Harbin, China, Changchun, China, Dalian, China, Panjin, China and 3 additional locations.
Who is sponsoring the NCT04136782 clinical trial?
NCT04136782 is sponsored by Shengjing Hospital. The principal investigator is Caigang Liu, M.D., Ph.D. at Shengjing Hospital. The trial plans to enroll 110 participants.
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