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

Neoadjuvant Therapy Clinical Trial

— ACCN  

Official title:

Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02769104
• Other study ID #: ZJCH-ACCN
• Status: Recruiting
• Phase: Phase 3
• First received: May 8, 2016
• Last updated: January 8, 2018
• Start date: May 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Zhejiang Cancer Hospital
• Contact: Hong-Jian Yang, MD.
• Email: yhjzlyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoadjuvant Therapy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effective rate	CR+PR	half year after randomized
Secondary	pCR	pathological CR	half year after randomized
Secondary	disease-free survival (DFS)	disease-free survival	2 years after randomized
Secondary	side effect rate		2 years after randomized