Breast Cancer
Conditions
Interventions
None listed
Sponsors
Japan Agency for Medical Research and Development
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The subjects are the patients enrolled in the following five clinical trials conducted by JBCRG and OOTR. i. JBCRG-01 (n=202) ii. JBCRG-02 (n=31) iii. JBCRG-02' (n=19) iv. JBCRG-03 (n=130) v. OOTR-N003 (n=500) In addition, perioperative chemotherapy-free hormone receptor positive breast cancer (HR+BC) patients will be collected targeting at 340 cases. Selection criteria for perioperative chemotherapy-free HR+BC cases are as follows according to the eligibility criteria of the above five clinical trials. Cases that satisfy all the following 1 to 7 1. Cases with histologically confirmed primary breast cancer (invasive cancer) and undergone curative resection 2. Cases in which TNM at diagnosis satisfies the following {cT1 c-3 cN0 cM0 (> 1 cm) / cT1-3 cN1 cM0} 3. Cases in which chemotherapy were not given as preoperative or postoperative adjuvant therapy (cases in which endocrine therapy were given are acceptable) 4. 20 years old or older and less than 70 years old 5. Cases in which regular follow-up has been performed at the facility where surgery for breast cancer was performed and of whom sufficient prognostic information can be obtained (Follow-up period must be over 5 years in cases without recurrence). 6. Cases in which the following samples can be submitted Cases with preoperative endocrine therapy: Biopsy tumor samples obtained before endocrine therapy (formalin fixed paraffin embedded tissue, total of 12 slides of 4 micro meter thick unstained specimens) Cases without preoperative endocrine therapy: Biopsy tumor samples at diagnosis or tumor samples resected by surgery (formalin fixed paraffin embedded tissue, total of 12 slides of 4 micro meter thick unstained specimens) 7. Cases diagnosed with primary breast cancer between August 2005 and July 2009 The number of cases in each facility is limited to 60 cases, and all eligible cases after August 2005 have to be registered consecutively.
Exclusion criteria
Exclusion criteria: 1. Male 2. Cases judged by investigator to be unfit to be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Countries
Japan
Contacts
Public ContactShin Takahashi
Institute of Development, Aging and Cancer, Tohoku University Department of Clinical Oncology
Outcome results
None listed