Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast Cancer
NCT ID: NCT02769104
Last Updated: 2018-01-09
Study Results
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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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2016-05-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Letrozole (Aromatase Inhibitors)
Letrozole (Aromatase Inhibitors) for 5 years
AC*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
Chemo
chemotherapy (AC\*4-T\*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer
AC*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
Interventions
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Letrozole (Aromatase Inhibitors)
Letrozole (Aromatase Inhibitors) for 5 years
AC*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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Hong-Jian Yang, MD.
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZJCH-ACCN
Identifier Type: -
Identifier Source: org_study_id
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