Efficacy and Safety of TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Breast Cancer
Study to Assessment the Efficacy and Safety of Joint TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Operable Breast Cancer
1 other identifier
interventional
600
1 country
1
Brief Summary
Select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jan 2012
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 3, 2012
August 1, 2012
11 months
July 19, 2012
August 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
therapeutic assessment
therapeutic assessment
6 months
Secondary Outcomes (1)
Adverse reactions and disease-free survival
2 years
Other Outcomes (1)
Recurrence or death
5 years
Study Arms (1)
Exemestane
EXPERIMENTALExemestane for neoadjuvant chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Karnofsky ≥ 70
- Provision of informed consent
- Pathological confirmation of invasive ductal carcinoma and estrogen receptor is positive
- Tumor stage(TNM):T2-4bN0-3M0
- Premenopausal woman
- Not previously received treatment with bisphosphonate
- Laboratory criteria:
- PLT ≥ 100\*109/L
- WBC ≥ 4000/mm3
- HGB ≥ 10g/dl
- GOT,GPT,ALP ≤ 2\*ULN
- TBIL,DBIL,CCr ≤ 1.5\*ULN
You may not qualify if:
- Pregnant or lactation woman
- History of organ transplantation
- With mental disease
- With severe infection or active gastrointestinal ulcers
- With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
- Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
- With heart disease
- Experimental drug allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
jin Zhang, Professor
Tianjin Cancer Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 19, 2012
First Posted
July 24, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
August 3, 2012
Record last verified: 2012-08