Working... Menu
Trial record 16 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01275859
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : August 29, 2017
Information provided by (Responsible Party):
Sung-Bae Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Letrozole, Lapatinib Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Letrozole and Lapatinib in Postmenopausal Women With ER and Her2 Positive Breast Cancer
Study Start Date : September 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Letrozole, Lapatinib
Letrozole 2.5mg po qd + Lapatinib 1500mg po qd for 18-21 wks
Drug: Letrozole, Lapatinib
Letrozole 2.5mg po qd+ Lapatinib 1500mg po qd for 18-21 wks
Other Names:
  • Femara
  • Tykerb

Primary Outcome Measures :
  1. pCR [ Time Frame: 2010 Nov- 2012 May ]
    To evaluate the pathologic complete response (pCR) rate to lapatinib combined with letrozole in neoadjuvant setting

Secondary Outcome Measures :
  1. SUV for [18F]FES PET [ Time Frame: 2010 Nov- 2012 May ]
    • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01275859

Layout table for location information
Korea, Republic of
Asan Nedical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Layout table for investigator information
Principal Investigator: Sung-Bae Kim, MD Asan Medical Center

Layout table for additonal information
Responsible Party: Sung-Bae Kim, Professor, Asan Medical Center Identifier: NCT01275859     History of Changes
Other Study ID Numbers: 2009-0729
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Sung-Bae Kim, Asan Medical Center:

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors