NCT01622361

Brief Summary

The purpose of this study is to compare neo-adjuvant therapy of cytotoxic chemotherapy versus GnRHa with tamoxifen , of response rate(RR) in patients of hormone responsive and HER2 negative, lymph node positive, primary breast cancer in premenopausal women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

September 30, 2013

Status Verified

September 1, 2013

Enrollment Period

3.7 years

First QC Date

June 13, 2012

Last Update Submit

September 26, 2013

Conditions

Breast Cancer

Keywords

Neoadjuvantendocrine therapypremenopausalhormone responsiveHER2 negativelymph node positive

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    6 months

Secondary Outcomes (1)

  • Pathologic complete response

    6 months

Study Arms (2)

Chemotherapy Group

ACTIVE COMPARATOR

Chemotherapy Adriamycin+Cyclophosphamide\>Docetaxel

Drug: Adriamycin+Cyclophosphamide>Docetaxel

Endocrine therapy group

EXPERIMENTAL

Endocrine therapy(GnRHa with Tamoxifen) group

Drug: GnRHa with Tamoxifen

Interventions

Adriamycin+Cyclophosphamide>DocetaxelDRUG

1. Adriamycin 60mg/m2 + Cyclophosphamide 600mg/m2 * Route: by slow intravenous bolus * Schedule: every 3weeks for 4 cycle 2. Docetaxel 75mg/m2 * Route: intravenous as per local practice * Schedule: every 3weeks for 4 cycle

Also known as: Chemotherapy
Chemotherapy Group
GnRHa with TamoxifenDRUG

1. Goserelin(GnRHa) 3.6mg * Route: subcutaneously under the abdominal skin * Schedule: every 4weeks for 6cycles (period of 34 days between 2 administrations must not be exceeded) 2. Tamoxifen 20mg/day * Route: Oral * Schedule: everyday

Also known as: Endocrine Therapy
Endocrine therapy group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment
  • Pathologically proven lymph node positive tumor(FNAB or Core biopsy)
  • Tumor must be ER positive(eligible patients include Allred score 5 and more, Modified Allred 4 and more) and HER-2 negative(IHC score is 0-1+; If IHC score is 2+, the result of FISH or SISH is negative)
  • Premenopausal women
  • Premenopausal status as defined by :
  • Last menses within 6 month of randomization or
  • For patients who have had a unilateral oophorectomy, E2 ≥ 20PG/mL and FSH \< 30mIU/Ml within 4 weeks of randomization
  • over 20 years old
  • Pre-treatment haematology and biochemistry values within acceptable limits :
  • ANC ≥ 1.5 × 109/l
  • Hb \> 9g/dl
  • Platelets ≥ 100 × 109/l
  • AST/ALT ≤ 1.5 × ULN(Upper Limit of Normal)
  • ALP ≤ 1.5 × ULN
  • Serum bilirubin ≤ 1.5 × ULN
  • +4 more criteria

You may not qualify if:

  • Inflammatory breast cancer
  • Inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment
  • Known severe hypersensitivity to GnRHa treatment
  • Bilateral invasive breast cancer
  • Other serious illness or medical condition:
  • congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
  • history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
  • active uncontrolled infection
  • HRT within 4 weeks of starting treatment
  • Definite contra-indications for the use of corticosteroids.
  • Last 10 years with a history of other malignant tumor (except in the case of basal cell carcinoma or cervical carcinoma in situ, and where treatment consisted solely of resection)
  • Systemic metastatic (Tests for the diagnosis of systemic metastatic comply with the guideline in each institution)
  • Pregnant or breastfeeding women
  • Chronic oral treatment with corticosteroids unless initiated \> 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

RECRUITING

Related Publications (3)

  • Gwark S, Noh WC, Ahn SH, Lee ES, Jung Y, Kim LS, Han W, Nam SJ, Gong G, Kim SO, Kim HJ. Axillary Lymph Node Dissection Rates and Prognosis From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer. Front Oncol. 2021 Sep 30;11:741120. doi: 10.3389/fonc.2021.741120. eCollection 2021.

    PMID: 34660302DERIVED

  • Gwark S, Ahn SH, Noh WC, Lee ES, Jung Y, Kim LS, Han W, Nam SJ, Gong G, Kim SO, Kim HJ. Patient-Reported Outcomes From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer. Front Oncol. 2021 Jul 2;11:608207. doi: 10.3389/fonc.2021.608207. eCollection 2021.

    PMID: 34277393DERIVED

  • Kim HJ, Noh WC, Lee ES, Jung YS, Kim LS, Han W, Nam SJ, Gong G-, Kim HJ, Ahn SH. Efficacy of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy in pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer. Breast Cancer Res. 2020 May 27;22(1):54. doi: 10.1186/s13058-020-01288-5.

    PMID: 32460816DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug TherapyTamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Ahn Sei Hyun, MD.PhD

CONTACT

82-2-3010-3490ahnsh@amc.seoul.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 19, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

September 30, 2013

Record last verified: 2013-09

Locations

KR(1)