Clinical trial NCT02769104: Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast Cancer
Official title: Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neoadjuvant Therapy
Keywords: aromatase inhibitors
chemotherapy
neoadjuvant
postmenopausal
breast cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: effective rate
timeFrame: half year after randomized
Secondary outcomes:
measure: pCR
timeFrame: half year after randomized
measure: disease-free survival (DFS)
timeFrame: 2 years after randomized
measure: side effect rate
timeFrame: 2 years after randomized
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Hong-Jian Yang, MD.
role: PRINCIPAL_INVESTIGATOR
References: