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Efficacy and Safety of TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Breast Cancer

This study is currently recruiting participants.
Verified August 2012 by Tianjin Medical University
Sponsor:
Information provided by (Responsible Party):
Zhang jin, Tianjin Medical University
ClinicalTrials.gov Identifier:
NCT01648608
First received: July 19, 2012
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Exemestane
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Exemestane
U.S. FDA Resources

Further study details as provided by Tianjin Medical University:

Primary Outcome Measures:
  • therapeutic assessment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    therapeutic assessment


Secondary Outcome Measures:
  • Adverse reactions and disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Adverse reactions and disease-free survival


Other Outcome Measures:
  • Recurrence or death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Recurrence or death


Estimated Enrollment: 600
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exemestane
Exemestane for neoadjuvant chemotherapy
 Drug: Exemestane
Exemestane for neoadjuvant chemotherapy
Other Name: 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648608

Locations
China, Tianjin
Tianjin Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: ZHANG SHENG, DOCTOR     86-022-23340123 ext 2901        
Contact: ZHANG SHENG, DORTOR     86-022-23340123 ext 2901        
Principal Investigator: ZHANG JIN, PROFESSOR            
Sponsors and Collaborators
Tianjin Medical University
Investigators
Study Chair: jin Zhang, Professor Tianjin cancer hospital
  More Information

No publications provided

Responsible Party: Zhang jin, Professor, Tianjin Medical University
ClinicalTrials.gov Identifier: NCT01648608     History of Changes
Other Study ID Numbers: TENBC
Study First Received: July 19, 2012
Last Updated: August 2, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013