Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Letrozole

Antineoplastic Agents, Immunological

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

- Concurrently initiate two drugs on Day 1 of Cycle 1

- Eight times IV administration of trastuzumab per 3 weeks

* Trastuzumab 8mg/kg on Day 1 of Cycle 1
* Trastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8

- Daily letrozole 2.5 mg/day for 24 weeks

Joon Jeong, M.D.,Ph.D.

Sung Gwe Ahn, M.D.

Lee Su Kim, M.D.,Ph.D.

Taehyun Kim, M.D.,Ph.D.

Junwon Min, M.D.,Ph.D.

Jae Il Kim, M.D., Ph.D.

Eun Sook Lee, M.D.,Ph.D.

Byung Ho Son, M.D.,Ph.D.

Chan Heun Park, M.D.,Ph.D.

Woo Chul Noh, M.D.,Ph.D.

Jeoung Won Bae, M.D.,Ph.D.

Seok Jin Nam, M.D.,Ph.D.

Dong Hui Cho

Wonshik Han, M.D.,Ph.D.

Yongsik Jung, M.D.,Ph.D.

The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and HER2-positive breast cancer.

Eligibility criteria

* Ages Eligible for Study: ≥ 20 years
* Invasive cancer (clinical stage IB-IIIB)
* Measurable tumor larger than 1cm
* ECOG status 0 or 1
* Postmenopausal women

  * Age ≥55 years and amenorrhea
  * Age \<55 years and amenorrhea for ≥12 months with FSH \>30 mIU/ml
* HER2 positive tumor

  * 3 positive on IHC
  * 2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
* Estrogen receptor positive tumor

  * Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7
* Eligible cardiac function

  * Normal heard evaluated by ECG

    * Consider clinically non-significant arrythmia and ischemic change as normal
  * LVEF ≥ 55% measured by ECHO or MUGA scan

Outcome measures

* Primary End-point

  * The rate of pathologic complete response (pCR)

    * No residual invasive cancer in breast
* Secondary End-point

  * Clinical Response Rate
  * Safety profiles for the preoperative use of concurrent trastuzumab and letrozole
  * The rate of breast conservative surgery
  * Total pathologic complete response (tpCR)

    * No residual invasive cancer in breast and ipsilateral axilla
  * Analysis of biomarkers based on baseline specimen and residual tumor
* Ki67 expression
* cDNA microarray: gene expression profiling
* Association between clinical response rate and circulating tumor cells (CTCs)

  * CTCs are measured by CytoGen (SEOUL, KOREA)"

Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women

A Phase II Trial of Preoperative HER2 Targeting and Endocrine Therapy in Postmenopausal Women With HER2 and HR Positive Breast Cancer

No residual invasive cancer in breast regardless of axilla

Clinical response includes complete response, partial response and stable disease.

Toxicity according to CTCAE protocol from the initiated day to 3 months after surgery

The rate of breast conservative surgery among the patients receiving surgery

No residual invasive cancer in breast and ipsilateral axilla

* Ki67 expression
* cDNA microarray: gene expression profiling

Association between clinical response rate and circulating tumor cells (CTCs)

: CTCs are measured by CytoGen (SEOUL, KOREA)"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women	NCT02214004	Breast Cancer	Trastuzumab Letrozole	18 Years -	Gangnam Severance Hospital
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women	NCT02214004	Breast Cancer	Trastuzumab Letrozole	18 Years -	Gangnam Severance Hospital

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