breast cancer
Conditions
Interventions
B:paclitaxel
Sponsors
Department of Breast Medical Oncology, Beijing Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adult women (ages 18-70 years, inclusive) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom there was either visceral crisis or rapidly progressive diseases; 2. Documentation of histologically or cytologically confirmed diagnosis of estrogen-receptor positive at least 10% (ER+=10%) breast cancer based on laboratory results; 3. Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease; 4. Postmenopausal status and premenopausal status with ovarian suppression drug; 5. Measurable disease as defined per RECIST v.1.1 or bone-only disease; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; 7. Life expectancy more than 3 months; 8. Adequate organ and bone marrow function defined as follows: (1) Absolute Neutrophil Count (ANC) =1,500/mm3 (1.5 x 109 /L); (2) Platelets =100,000/mm3 (100 x 10^9/L); (3) Hemoglobin =9 g/dL (90 g/L); (4)Serum creatinine =1.5 x Upper Limit of Normal (ULN) or estimated creatinine clearance = 60 mL/min as calculated using the method standard for the institution; (5)Total serum bilirubin =1.5 x ULN (=3.0 x ULN if Gilberts disease); (6) AST and/or ALT =3 x ULN (=5.0 x ULN if liver metastases present); 9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion criteria
Exclusion criteria: 1. HER2-positive tumor as defined by documentation of erbB-2 gene amplification by FISH (as defined by a HER2/CEP17 ratio =2) or chromogenic in situ hybridization (CISH, as defined by the manufacturers kit instruction) or documentation of HER2-overexpression by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local laboratory results utilizing one of the sponsor-approved assays; 2. Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including pulmonary lymphangitis, and over 50% liver involvement); 3. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis,or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization; 4. Prior neoadjuvant or adjuvant treatment with paclitaxel with disease recurrence while on or within 12 months of completing treatment; 5. Prior neoadjuvant or adjuvant treatment with a steroidal aromatase inhibitor exemestane with disease recurrence while on or within 12 months of completing treatment; 6. Major surgery, chemotherapy, radiotherapy, any investigational agents, or other anti-cancer therapy within 2 weeks before randomization; 7. Diagnosis of any other malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix; 8. Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade =2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism; 9. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection; 10. Known hypersensitivity to paclitaxel or exemestane; 11. Patients with pregnancy and lactation; 12. Patients with severe or uncontrolled complications, such as infection requiring systemic therapy, uncontrolled diabetes or hypertension, and other complications that may interfere with drug therapy; 13. HIV virus, hepatitis B virus, hepatitis C virus infection occurred recently known; 14. Other severe acute or chronic medical or psychiatric condition (including recent or active suicidal ideation or behavior) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactHuiping Li
Department of Breast Medical Oncology, Beijing Cancer Hospital
Outcome results
None listed