Efficacy and Safety of TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Exemestane
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Tianjin Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exemestane
Arm Description
Exemestane for neoadjuvant chemotherapy
Outcomes
Primary Outcome Measures
therapeutic assessment
therapeutic assessment
Secondary Outcome Measures
Adverse reactions and disease-free survival
Adverse reactions and disease-free survival
Full Information
NCT ID
NCT01648608
First Posted
July 19, 2012
Last Updated
August 2, 2012
Sponsor
Tianjin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01648608
Brief Title
Efficacy and Safety of TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Breast Cancer
Official Title
Study to Assessment the Efficacy and Safety of Joint TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Operable Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The investigators 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exemestane
Arm Type
Experimental
Arm Description
Exemestane for neoadjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
Exemestane
Intervention Description
Exemestane for neoadjuvant chemotherapy
Primary Outcome Measure Information:
Title
therapeutic assessment
Description
therapeutic assessment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adverse reactions and disease-free survival
Description
Adverse reactions and disease-free survival
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Recurrence or death
Description
Recurrence or death
Time Frame
5 years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jin Zhang, Professor
Organizational Affiliation
Tianjin Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZHANG SHENG, DOCTOR
Phone
86-022-23340123
Ext
2901
First Name & Middle Initial & Last Name & Degree
ZHANG SHENG, DORTOR
Phone
86-022-23340123
Ext
2901
First Name & Middle Initial & Last Name & Degree
ZHANG JIN, PROFESSOR
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Breast Cancer
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