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Breast CancerPhase 3NESTNCT01622361

Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer

A Phase 3 study testing Adriamycin+Cyclophosphamide>Docetaxel and GnRHa with Tamoxifen in people with Breast Cancer, run by Asan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Adriamycin+Cyclophosphamide>Docetaxel and GnRHa with Tamoxifen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
1 siteSouth Korea
Study dates
Jun 2012to Feb 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Serum creatinine ≤ 1.5 × ULN
  • ECOG PS of 0 or 1
  • No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up
  • Before any study-specific procedures, the appropriate written informed consent must be obtained

Who cannot join

  • 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
Show all 14Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Ahn Sei Hyun, MD.PhD contact

82-2-3010-3490

ahnsh@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, Songpa-gu, 138-736

    Ahn Sei Hyun, M.D., 82-2-3010-3490, ahnsh@amc.seoul.kr

    A. S. Hyun, MD.PhD

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase III, Open-Label, Prospective, Randomized, Multicenter, Neo-adjuvant Study of Chemotherapy Versus Endocrine Therapy in Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer

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.

Read the detailed description
  1. Primary objective : Response Rate-MRI and/or Caliper
  2. Secondary objectives
  • Pathologic complete response
  • Rate of conservation surgery
  • Ki-67 changes and its relationship to treatment response
  • Length of time to maximum response within the treatment period
  • Tolerability of two treatments
  • Disease-free survival(DFS)
  • Overall survival
Conditions
Breast Cancer
Being tested
Adriamycin+Cyclophosphamide>Docetaxel, GnRHa with Tamoxifen
Keywords
Neoadjuvant, endocrine therapy, premenopausal, hormone responsive, HER2 negative, lymph node positive
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adriamycin+Cyclophosphamide>DocetaxelDrug

    Also called Chemotherapy

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

  • GnRHa with TamoxifenDrug

    Also called Endocrine Therapy

    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)
    1. Tamoxifen 20mg/day
    • Route: Oral
    • Schedule: everyday
Study groups in NCT01622361
Study groupRoleWhat they receive
Chemotherapy GroupActive comparatorChemotherapy Adriamycin+Cyclophosphamide>Docetaxel
Receives: Drug: Adriamycin+Cyclophosphamide>Docetaxel
Endocrine therapy groupExperimentalEndocrine therapy(GnRHa with Tamoxifen) group
Receives: Drug: GnRHa with Tamoxifen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    Measured: 6 months

Secondary outcomes (1)

  1. Pathologic complete response

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionFeb 2016 (estimated)
  4. Study completionFeb 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01622361
Sponsor's protocol ID
KBCSG012
Acronym
NEST
Status last verified
Sep 2013
First submitted
13 Jun 2012
Last updated
30 Sep 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34660302

  • 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.

    PubMed 34277393

  • 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.

    PubMed 32460816

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adriamycin+Cyclophosphamide>Docetaxel and GnRHa with Tamoxifen in people with Breast Cancer, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahn Sei Hyun, MD.PhD (82-2-3010-3490, ahnsh@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01622361, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2013.

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