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

Conditions

Breast Cancer

Keywords

Neoadjuvant, endocrine therapy, premenopausal, hormone responsive, HER2 negative, lymph node positive

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.

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

Sungchan Gwark, Sei Hyun Ahn, Jong Won Lee, Byung Ho Son, Beom Seok Ko et al. (14 authors)

Cancer Research2023-03-01

10.1158/1538-7445.sabcs22-p2-10-02

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

Sungchan Gwark, Woo Chul Noh, Sei Hyun Ahn, Kyu Eun Lee, Yong Sik Jung et al. (11 authors)

Frontiers in Oncology2021-09-306 citations

10.3389/fonc.2021.741120

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

Sungchan Gwark, Sei Hyun Ahn, Woo Chul Noh, Kyu Eun Lee, Yong Sik Jung et al. (11 authors)

Frontiers in Oncology2021-07-021 citations

10.3389/fonc.2021.608207

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.

Kim HJ, Noh WC, Lee ES, Jung YS, Kim LS, Han W, Nam SJ, Gong G-, Kim HJ, Ahn SH.

2020-05-2744 citations

10.1186/s13058-020-01288-5

Neoadjuvant endocrine therapy versus neoadjuvant chemotherapy in young women with breast cancer: Prognosis and axillary node surgery.

Sungchan Gwark, Sei Hyun Ahn, Jin‐Hee Ahn, Kyung Hae Jung, Sung‐Bae Kim et al. (14 authors)

Journal of Clinical Oncology2020-05-20

10.1200/jco.2020.38.15_suppl.e12626

Sungchan Gwark, Sei Hyun Ahn, Woo Chul Noh, Eun Sook Lee, Yong Sik Jung et al. (11 authors)

Journal of Clinical Oncology2020-05-20

10.1200/jco.2020.38.15_suppl.e19242

A phase III, open label, prospective, randomized, multicenter, neoadjuvant study of chemotherapy versus endocrine therapy in premenopausal patient with hormone responsive, HER2 negative, breast cancer (KBCSG 012).

hee Jeong Kim, Woo Chul Noh, Eun Sook Lee, Leesu Kim, Yong Sik Jung et al. (8 authors)

Journal of Clinical Oncology2017-05-201 citations

10.1200/jco.2017.35.15_suppl.517

Interventions

DRUGAdriamycin+Cyclophosphamide>Docetaxel

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

DRUGGnRHa with Tamoxifen

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment 2. Pathologically proven lymph node positive tumor(FNAB or Core biopsy) 3. 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) 4. 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 5. over 20 years old 6. 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 7. ECOG PS of 0 or 1 8. No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up 9. Before any study-specific procedures, the appropriate written informed consent must be obtained

Exclusion criteria

1. Inflammatory breast cancer 2. Inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment 3. Known severe hypersensitivity to GnRHa treatment 4. Bilateral invasive breast cancer 5. 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 6. HRT within 4 weeks of starting treatment 7. Definite contra-indications for the use of corticosteroids. 8. 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) 9. Systemic metastatic (Tests for the diagnosis of systemic metastatic comply with the guideline in each institution) 10. Pregnant or breastfeeding women 11. Chronic oral treatment with corticosteroids unless initiated \> 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent).

Design outcomes

Primary

Measure	Time frame
Response Rate	6 months

Secondary

Measure	Time frame
Pathologic complete response	6 months

Countries

South Korea

Contacts

Primary ContactAhn Sei Hyun, MD.PhD

ahnsh@amc.seoul.kr82-2-3010-3490

Outcome results

None listed