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

Breast Cancer Clinical Trial

— Neo-All-In  

Official title:

Neoadjuvant Letrozole and Lapatinib in Postmenopausal Women With ER and Her2 Positive Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275859
• Other study ID #: 2009-0729
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2011
• Last updated: August 26, 2017
• Start date: September 2010
• Est. completion date: May 2014

Study information

• Verified date: August 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole, Lapatinib
Letrozole 2.5mg po qd+ Lapatinib 1500mg po qd for 18-21 wks

Locations

Country	Name	City	State
Korea, Republic of	Asan Nedical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	To evaluate the pathologic complete response (pCR) rate to lapatinib combined with letrozole in neoadjuvant setting	2010 Nov- 2012 May
Secondary	SUV for [18F]FES PET	To evaluate clinical overall response (cORR) rate, disease free survival (DFS), overall survival (OS); To assess tolerability and QOL; To assess MRI response rate; To identify biological predictors of response to lapatinib combined letrozole treatment; To determine the correlation of [18F]FES PET with biological and imaging predictors of response to the combined modalities; To evaluate the diagnostic value of SUV for [18F]FES PET in the prediction of pathologic, clinical response to neoadjuvant HER2 target- and endocrine therapy	2010 Nov- 2012 May