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

NCT02769104 | Unknown Phase 3 DMC

• 1 other identifier: ZJCH-ACCN
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoadjuvant Therapy

Keywords

aromatase inhibitors; chemotherapy; neoadjuvant; postmenopausal; breast cancer

Outcome Measures

Primary Outcomes (1)

• effective rate

  CR+PR

  half year after randomized

Secondary Outcomes (3)

• pCR

  half year after randomized

• disease-free survival (DFS)

  2 years after randomized

• side effect rate

  2 years after randomized

Study Arms (2)

AI+Chemo

EXPERIMENTAL

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

Drug: Letrozole (Aromatase Inhibitors); Drug: AC*4-T*4

Chemo

ACTIVE COMPARATOR

chemotherapy (AC\*4-T\*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer

Drug: AC*4-T*4

Interventions

Letrozole (Aromatase Inhibitors) DRUG

Letrozole (Aromatase Inhibitors) for 5 years

Also known as: Letrozole

AI+Chemo

AC*4-T*4 DRUG

CTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks\*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks\*4cycles

Also known as: CTX+Anthracyclines, Docetaxel

AI+Chemo; Chemo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Aromatase Inhibitors; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Hong-Jian Yang, MD.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong-Jian Yang, MD.

CONTACT

yhjzlyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

CN (1)