Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as... | NCT02769104

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

NCT02769104

Sponsor

Zhejiang Cancer Hospital

Status

Unknown status

Last Update Posted

Jan 9, 2018Actual

Enrollment

120Estimated

Phase

Phase 3

Conditions

Neoadjuvant Therapy

Interventions

Letrozole (Aromatase Inhibitors)
AC*4-T*4

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Jul 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

May 8, 2016

First Submission Date that Met QC Criteria

May 10, 2016

First Posted Date

May 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2018

Last Update Posted Date

Jan 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AI+Chemo	Experimental	aromatase inhibitors (Letrozole 2.5mg po. QD for 5 years) starts at the beginning of neoadjuvant treatment combined with chemotherapy (AC4-T4) in patients with postmenopausal hormone receptor-positive breast cancer	Drug: Letrozole (Aromatase Inhibitors) Drug: AC4-T4
Chemo	Active Comparator	chemotherapy (AC4-T4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer	Drug: AC4-T4

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Letrozole (Aromatase Inhibitors)	Drug	Letrozole (Aromatase Inhibitors) for 5 years	AI+Chemo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effective rate	CR+PR	half year after randomized

Secondary Outcomes

Measure	Description	Time Frame
pCR	pathological CR	half year after randomized
disease-free survival (DFS)	disease-free survival	2 years after randomized

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Hong-Jian Yang, MD.	Contact			yhjzlyy@163.com

Name	Affiliation	Role
Hong-Jian Yang, MD.	Zhejiang Cancer Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Zhejiang Cancer Hospital	Recruiting	Hangzhou	Zhejiang	310022	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The investigators have not decided if the data can be available.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D000077289	Letrozole
D047072	Aromatase Inhibitors
D000077143	Docetaxel

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573