Status:
RECRUITING
Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer
Lead Sponsor:
Shengjing Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
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.
Detailed Description
Triple-negative breast cancer is named because of lack of expression of estrogen receptor, progesterone receptor, and proto-oncogene HER2. This type of breast cancer is highly heterogeneous, is more l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04136782
Start Date
July 19 2021
End Date
November 30 2026
Last Update
July 20 2021
Active Locations (7)
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1
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China, 150081
2
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
3
Dalian Municipal Central Hospital
Dalian, Liaoning, China, 116033
4
Panjin Liaohe Oilfield Gem Flower Hospital
Panjin, Liaoning, China, 124010