Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

There are no standard neodjuvant regimens adapted according to the different subtypes of breast cancer. This is a phase 2, randomized study to evaluate several regimens in different subtypes of breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Epirubicin; Paclitaxel

Criteria

Inclusion Criteria:

• Stage IIa-IIIc breast cancer patients plan to receive neoadjuvant chemotherapy

• Patients have enough tissue sample to do IHC test for subtype classification

• Patients have at least one measurable lesion according to RECIST1.1

• KPS≥80

• No prior treatment for breast cancer

• Adequate bone marrow (neutrophil count ≥1500 ml and platelet count ≥100,000 ml), renal (serum creatinine <1.5 times the upper limit of normal [ULN] or a creatinine clearance of ≥60 ml/minute), hepatic (total bilirubin ≤1.5 ULN; alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase ≤2.5 ULN), and cardiac function (assessed by electrocardiogram or thoracic radiography) were required.

Exclusion Criteria:

• Fertile women were excluded if pregnant or lactating or if they were not using adequate contraception.

• Previous chemotherapy for breast cancer.

• history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, AIDS), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for >10 years).