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Study to Assessment the Efficacy and Safety of Joint TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Operable Breast Cancer


Phase 2/Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Study to Assessment the Efficacy and Safety of Joint TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Operable Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

therapeutic assessment

Outcome Description:

therapeutic assessment

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

jin Zhang, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Tianjin cancer hospital

Authority:

China: Ministry of Health

Study ID:

TENBC

NCT ID:

NCT01648608

Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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