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

January 8, 2018 updated by: Zhejiang Cancer Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Hong-Jian Yang, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI+Chemo
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)
Letrozole (Aromatase Inhibitors) for 5 years
Other Names:
  • Letrozole
Drug: 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
Other Names:
  • CTX+Anthracyclines, Docetaxel
Active Comparator: Chemo
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
CTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks*4cycles
Other Names:
  • CTX+Anthracyclines, Docetaxel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Hong-Jian Yang, MD., Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 8, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJCH-ACCN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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