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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Aromatase Inhibitors; Docetaxel; Hormones; Letrozole

Criteria

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