Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast Cancer

Study Overview
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Brief Summary
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The investigators designed this study to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.

Detailed Description
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The endocrine therapy has been used more and more in neoadjuvant treatment of hormone receptor-positive breast cancer. But it still a question if neoadjuvant endocrine therapy can be used combined with chemotherapy. There have been several small-sample studies concerning about this item and also got some results that support the suppose that endocrine therapy combined with chemotherapy could rise the effect of neoadjuvant treatment. This study is to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.

Official Title
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Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer

Conditions
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Neoadjuvant Therapy

Intervention / Treatment
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* Drug: Letrozole (Aromatase Inhibitors)
* Drug: AC*4-T*4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: provision of informed consent clinical stage IIA IIIC histologically proven HR+ invasive breast cancer women defined as postmenopausal according to NCCN guideline plan to accept the neoadjuvant (pre operational) chemotherapy treatment Exclusion Criteria: clinical evidence of metastatic disease bilateral oophorectomy; radiation of the ovaries patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements patients who accepted anti-cancer treatment before previous hormonal therapy as adjuvant treatment for non-cancer disease patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied treatment with a non-approved or experimental drug during 1 month before entry into the study history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin) leukopenia and/or thrombocytopenia history of ocular fundus diseases history of thromboembolic diseases history of osteoporotic fractures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI+Chemo<br>aromatase inhibitors (Letrozole 2.5mg po. QD for 5 years) starts at the beginning of neoadjuvant treatment combined with chemotherapy (AC*4-T*4) in patients with postmenopausal hormone receptor-positive breast cancer | Drug: Letrozole (Aromatase Inhibitors)<br>* Letrozole (Aromatase Inhibitors) for 5 years<br>* Other names: Letrozole;Drug: AC*4-T*4<br>* CTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks*4cycles<br>* Other names: CTX+Anthracyclines, Docetaxel;|
| Active Comparator: Chemo<br>chemotherapy (AC*4-T*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer | Drug: AC*4-T*4<br>* CTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks*4cycles<br>* Other names: CTX+Anthracyclines, Docetaxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective rate | CR+PR | half year after randomized | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCR | pathological CR | half year after randomized | 
| disease-free survival (DFS) | disease-free survival | 2 years after randomized | 
| side effect rate |  | 2 years after randomized | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatase inhibitors, chemotherapy, neoadjuvant, postmenopausal, breast cancer