Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- effective rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
AI+Chemo
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
Intervention: Letrozole (Aromatase Inhibitors) (Drug)
AI+Chemo
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
Intervention: AC*4-T*4 (Drug)
Chemo
chemotherapy (AC*4-T*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer
Intervention: AC*4-T*4 (Drug)
Outcomes
Primary Outcomes
effective rate
Time Frame: half year after randomized
CR+PR
Secondary Outcomes
- pCR(half year after randomized)
- disease-free survival (DFS)(2 years after randomized)
- side effect rate(2 years after randomized)