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

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

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 Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exemestane; Exemestane for neoadjuvant chemotherapy	Drug: Exemestane; Exemestane for neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
therapeutic assessment	therapeutic assessment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions and disease-free survival	Adverse reactions and disease-free survival	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence or death	Recurrence or death	5 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 23, 2012
• First Posted (Estimate): July 24, 2012

Study Record Updates

• Last Update Posted (Estimate): August 3, 2012
• Last Update Submitted That Met QC Criteria: August 2, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Exemestane
• Other Study ID Numbers: TENBC