search
Back to results

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
Tianjin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Karnofsky ≥ 70
  2. Provision of informed consent
  3. Pathological confirmation of invasive ductal carcinoma and estrogen receptor is positive
  4. Tumor stage(TNM):T2-4bN0-3M0
  5. Premenopausal woman
  6. Not previously received treatment with bisphosphonate

  7. 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:

  1. Pregnant or lactation woman
  2. History of organ transplantation
  3. With mental disease
  4. With severe infection or active gastrointestinal ulcers
  5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
  6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
  7. With heart disease
  8. 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

First Posted
July 19, 2012
Last Updated
August 2, 2012
Sponsor
Tianjin Medical University
search

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

We'll reach out to this number within 24 hrs