Pre-operative Therapy in Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRenJi Hospital
About this trial
This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, Aged ≥18 years
Histologically confirmed primary breast cancer
Plan to receive pre-operative therapy
Adequate organ function
Disqualifiers
History of neurological or psychological disease, including epilepsy or dementia
Not suitable to participate in this study judged by investigators
Trial population
The study population will be selected from the hospital where they are treated
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
pre-operative therapy
Drugpre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy
Treatment groups
6,032 Participants
are divided into 2 treatment groupsGroup A: early breast cancer1 intervention
Group B: advanced breast cancer1 intervention
Trial outcomes
Primary outcomes
1
Pathologic Complete Response
ypT0 ypN0, ypT0/is ypN0
Time frame
at surgerySecondary outcomes
1
Objective response rate
the rate of complete response and partial response
Time frame
from the start of pre-operative treatment until the completion of surgery up to 6 months2
Disease-free Survival
Disease-free survival time is defined as the time from date of randomization until the first occurrence of disease recurrence, distant metastasis and death from any cause.
Time frame
From surgery until time of event up to 8 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov