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

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ClinicalTrials.gov Identifier: NCT01648608
Recruitment Status : Unknown
Verified August 2012 by Zhang jin, Tianjin Medical University.
Recruitment status was:  Recruiting
First Posted : July 24, 2012
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
Zhang jin, Tianjin Medical University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Exemestane Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane

Arm Intervention/treatment
Experimental: Exemestane
Exemestane for neoadjuvant chemotherapy
Drug: Exemestane
Exemestane for neoadjuvant chemotherapy




Primary Outcome Measures :
  1. therapeutic assessment [ Time Frame: 6 months ]
    therapeutic assessment


Secondary Outcome Measures :
  1. Adverse reactions and disease-free survival [ Time Frame: 2 years ]
    Adverse reactions and disease-free survival


Other Outcome Measures:
  1. Recurrence or death [ Time Frame: 5 years ]
    Recurrence or death



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Zhang jin, Professor, Tianjin Medical University
ClinicalTrials.gov Identifier: NCT01648608     History of Changes
Other Study ID Numbers: TENBC
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs