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

NCT ID: NCT01648608

Last Updated: 2012-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exemestane

Exemestane for neoadjuvant chemotherapy

Group Type EXPERIMENTAL

Exemestane

Intervention Type DRUG

Exemestane for neoadjuvant chemotherapy

Interventions

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Exemestane

Exemestane for neoadjuvant chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhang jin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jin Zhang, Professor

Role: STUDY_CHAIR

Tianjin Cancer Hospital

Locations

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Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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ZHANG SHENG, DOCTOR

Role: primary

ZHANG SHENG, DORTOR

Role: backup

Other Identifiers

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TENBC

Identifier Type: -

Identifier Source: org_study_id