Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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

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.

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

- 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

- Pregnant or nursing mother (if applicable)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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

Outcome Time Frame:

2010 Nov- 2012 May

Safety Issue:


Principal Investigator

Sung-Bae Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

April 2013

Related Keywords:

  • Breast Cancer
  • Neoadjuvant
  • Letrozole
  • Lapatinib
  • Postmenopausal
  • Breast Neoplasms