Neoadjuvant Combined Endocrine and HER2 Target Therapy in Postmenopausal Women With ER and Her2 Positive Breast Cancer (Neo-All-In)

Asan Medical Center

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Letrozole, Lapatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT01275859

2009-0729

Details and patient eligibility

About

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.

Full description

To evaluate the efficacy of the neoadjuvant combination therapy with letrozole and lapatinib in postmenopausal patients with ER-positive and HER2-positive breast cancer.
To assess markers predictive of treatment response and outcome in this setting.

Enrollment

25 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)