Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women

NCT02214004 | Unknown Phase 2 DMC

• 1 other identifier: HERAKLES
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; HER2; ER; Postmenopausal; Trastuzumab; Letrozole; Neoadjuvant endocrine treatment

Outcome Measures

Primary Outcomes (1)

• The rate of pathologic complete response

  No residual invasive cancer in breast regardless of axilla

  At time of surgery

Secondary Outcomes (6)

• Clinical Response Rate

  At time of surgery

• Safety profiles for the preoperative use of concurrent trastuzumab and letrozole

  Up to 3 months after surgery

• The rate of breast conservative surgery

  Up to 3 weeks after surgery

• Total pathologic complete response (tpCR)

  At time of surgery

• Analysis of biomarkers based on baseline specimen and residual tumor

  Baseline and at time of surgery

Study Arms (1)

Trastuzumab and Letrozole

EXPERIMENTAL

\- Concurrently initiate two drugs on Day 1 of Cycle 1

Drug: Trastuzumab; Drug: Letrozole

Interventions

Trastuzumab DRUG

\- 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

Also known as: Herceptin

Trastuzumab and Letrozole

Letrozole DRUG

\- Daily letrozole 2.5 mg/day for 24 weeks

Also known as: Femara

Trastuzumab and Letrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive cancer (clinical stage IB-IIIC)
• 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
• positive on IHC
• 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

You may not qualify if:

• Inflammatory breast cancer
• Bilateral breast cancer
• Patients with previous breast cancer history
• Patients with previous breast cancer treatment: Generally include hormone therapy, chemotherapy, and radiotherapy)
• Patients having uncontrolled heart problems
• Ischemic heart disease within 6 months
• Congestive heart failure more than NYHA class II
• Unstable angina
• Clinically significant pericarditis
• Amyloid heart disease

Sponsors & Collaborators

• Gangnam Severance Hospital: lead
• Seoul National University Hospital: collaborator
• Severance Hospital: collaborator
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator

Study Sites (14)

Hallym University Sacred Heart Hospital

Anyang, South Korea

RECRUITING

Inje University Pusan Paik Hospital

Busan, South Korea

NOT YET RECRUITING

Dankook University Hospital

Cheonan, South Korea

RECRUITING

Ilsan Paik Hospital

Goyang, South Korea

RECRUITING

National Cancer Center

Goyang, South Korea

NOT YET RECRUITING

Gangnam Severance Hospital

Seoul, 135720, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

NOT YET RECRUITING

Kangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

Korea Institute of Radiological and Medical Sciences

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

NOT YET RECRUITING

Seoul Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Ajou University School of Medicine

Suwon, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Joon Jeong, M.D.,Ph.D.

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82220193370; gsjjoon@yuhs.ac

Sung Gwe Ahn, M.D.

CONTACT

82220194402; asg2004@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 12, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

KR (14)