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

NCT01275859 | Completed Phase 2

• 1 other identifier: 2009-0729
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Neoadjuvant; Letrozole; Lapatinib; Postmenopausal

Outcome Measures

Primary Outcomes (1)

• pCR

  To evaluate the pathologic complete response (pCR) rate to lapatinib combined with letrozole in neoadjuvant setting

  2010 Nov- 2012 May

Secondary Outcomes (1)

• SUV for [18F]FES PET

  2010 Nov- 2012 May

Study Arms (1)

Letrozole, Lapatinib

EXPERIMENTAL

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

Drug: Letrozole, Lapatinib

Interventions

Letrozole, Lapatinib DRUG

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

Also known as: Femara, Tykerb

Letrozole, Lapatinib

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Nedical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Lapatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sung-Bae Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

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: January 12, 2011
• First Posted: January 13, 2011
• Study Start: September 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

KR (1)