Neoadjuvant Therapy
Conditions
Keywords
aromatase inhibitors, chemotherapy, neoadjuvant, postmenopausal, breast cancer
Brief summary
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
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.
Interventions
Letrozole (Aromatase Inhibitors) for 5 years
DRUGAC*4-T*4
CTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks\*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks\*4cycles
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effective rate | half year after randomized | CR+PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pCR | half year after randomized | pathological CR |
| disease-free survival (DFS) | 2 years after randomized | disease-free survival |
| side effect rate | 2 years after randomized | — |
Countries
China
Contacts
Primary ContactHong-Jian Yang, MD.
Outcome results
None listed