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

Primary Purpose

Neoadjuvant Therapy

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Letrozole (Aromatase Inhibitors)
AC*4-T*4
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoadjuvant Therapy focused on measuring aromatase inhibitors, chemotherapy, neoadjuvant, postmenopausal, breast cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AI+Chemo

Chemo

Arm Description

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

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

Outcomes

Primary Outcome Measures

effective rate
CR+PR

Secondary Outcome Measures

pCR
pathological CR
disease-free survival (DFS)
disease-free survival
side effect rate

Full Information

First Posted
May 8, 2016
Last Updated
January 8, 2018
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02769104
Brief Title
Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast Cancer
Acronym
ACCN
Official Title
Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoadjuvant Therapy
Keywords
aromatase inhibitors, chemotherapy, neoadjuvant, postmenopausal, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AI+Chemo
Arm Type
Experimental
Arm Description
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
Arm Title
Chemo
Arm Type
Active Comparator
Arm Description
chemotherapy (AC*4-T*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer
Intervention Type
Drug
Intervention Name(s)
Letrozole (Aromatase Inhibitors)
Other Intervention Name(s)
Letrozole
Intervention Description
Letrozole (Aromatase Inhibitors) for 5 years
Intervention Type
Drug
Intervention Name(s)
AC*4-T*4
Other Intervention Name(s)
CTX+Anthracyclines, Docetaxel
Intervention Description
CTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks*4cycles
Primary Outcome Measure Information:
Title
effective rate
Description
CR+PR
Time Frame
half year after randomized
Secondary Outcome Measure Information:
Title
pCR
Description
pathological CR
Time Frame
half year after randomized
Title
disease-free survival (DFS)
Description
disease-free survival
Time Frame
2 years after randomized
Title
side effect rate
Time Frame
2 years after randomized

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong-Jian Yang, MD.
Email
yhjzlyy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong-Jian Yang, MD.
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong-Jian Yang, MD.
Email
yhjzlyy@163.com
First Name & Middle Initial & Last Name & Degree
Hong-Jian Yang, MD.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators have not decided if the data can be available.

Learn more about this trial

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

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