Status:
NOT_YET_RECRUITING
Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy
Lead Sponsor:
Shengjing Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief Summary
With the development of neoadjuvant therapy for tumors, neoadjuvant chemotherapy (NAC) has become one of the most common and effective methods for preoperative systemic treatment of locally advanced b...
Detailed Description
reast cancer is one of the most prevalent malignant tumors in women, accounting for 23% of all malignant tumors. Approximately 1.3 million people are diagnosed with breast cancer every year in the wor...
Eligibility Criteria
Inclusion
- pathological examination confirms estrogen receptor positive, and Ki67 \< 30% in breast cancer patients;
- postmenopausal women;
- tumor size stage ≥ T3, or lymph node stage ≥ N2, or ipsilateral upper extremity edema or the extent of lesions exceeds the scope of radical surgery;
- Karnofsky functional status score ≥ 70;
- normal findings of blood examination, normal liver and kidney functions, and basically normal electrocardiogram results before chemotherapy;
- age range from 18-70 years old.
Exclusion
- history of anti-tumor treatment;
- inflammatory breast cancer or occult breast cancer;
- stage IV breast cancer;
- history of other malignant tumors;
- severe vital organ dysfunction, such as heart, liver and kidney or poor constitution cannot tolerate chemotherapy, or the treatment plan change due to intolerance during chemotherapy;
- cannot comply with the treatment because of mental and neurological diseases;
- dexamethasone contraindications or severe allergies to any drug in NAC;
- receiving NAC, but it is judged to be ineffective after two cycles of treatment, and other programs are forced to be used or chemotherapy is stopped to receive surgery;
- participation in other clinical trials.
Key Trial Info
Start Date :
July 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04137640
Start Date
July 19 2021
End Date
May 31 2026
Last Update
July 20 2021
Active Locations (1)
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1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004