Neoadjuvant Combined Endocrine and HER2 Target Therapy in Postmenopausal Women With ER and Her2 Positive Breast Cancer

NCT ID: NCT01275859

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-05-31

Brief Summary

Cross-talk between epidermal growth factors and the ER occurs at multiple levels and seems to play a crucial role in breast cancer progression and endocrine resistance.Combined HER1/HER2-targeted therapy with aromatase inhibitors for ER-positive and HER-2 positive postmenopausal breast cancer might enhance response and block emergence of endocrine resistant tumor.

Detailed Description

1. To evaluate the efficacy of the neoadjuvant combination therapy with letrozole and lapatinib in postmenopausal patients with ER-positive and HER2-positive breast cancer.

2. To assess markers predictive of treatment response and outcome in this setting.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Letrozole, Lapatinib

Letrozole 2.5mg po qd + Lapatinib 1500mg po qd for 18-21 wks

Group Type: EXPERIMENTAL

Letrozole, Lapatinib

Intervention Type: DRUG

Letrozole 2.5mg po qd+ Lapatinib 1500mg po qd for 18-21 wks

Interventions

Letrozole, Lapatinib

Letrozole 2.5mg po qd+ Lapatinib 1500mg po qd for 18-21 wks

Intervention Type: DRUG

Other Intervention Names

Femara; Tykerb

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Female patients
• Histologically confirmed invasive breast cancer
• Primary tumor greater than 2cm diameter, measured by sonography
• N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed)
• ER positive (intermediate and strong positive)
• HER2 positive (IHC3+ or FISH positive in case of IHC 2+)
• No evidence of metastasis (M0)
• No prior hormonal, chemotherapy or radiotherapy is allowed
• No breast operation other than biopsy to make diagnosis is allowed
• Postmenopausal women with ECOG Performance Status of 0 or 1
• Postmenopausal, as defined by any of the following:
• At least 55 years of age
• Under 55 years of age and amenorrheic for at least 12 months OR follicle-stimulating hormone (FSH) values ≥ 30 IU/L and estradiol levels ≤ 20 IU/L
• Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months
• Adequate hematopoietic, renal, hepatic function:

Exclusion Criteria

• Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
• Patients who underwent surgery for breast cancer
• Patients with bilateral invasive breast cancer
• Patients with inflammatory breast cancer (T4d)
• Patients without primary tumor (T0) Inability to perform [18F]FES PET imaging due to physical inability, claustrophobia, or other mental illness.
• ER poor disease as defined locally (e.g: Allred score 1-3, H-score<100)
• Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
• Chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day)
• Chronic daily treatment with corticosteroids (dose of >10mg /day ethylprednisolone equivalent)
• Clinically significant cardiovascular disease: CVA/stroke (<6month prior to enroll), MI (<6month prior to enroll), unstable angina, NYHA Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication.
• Hormone replacement therapy within 4 weeks of starting treatment
• Known hypersensitivity to any of the study drugs including ditosylate monohydrate salt
• Pregnant or nursing mother (if applicable)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sung-Bae Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Bae Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Nedical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2009-0729

Identifier Type: -

Identifier Source: org_study_id