Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Sung-Bae Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01275859
First received: January 12, 2011
Last updated: November 19, 2013
Last verified: July 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Letrozole, Lapatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Letrozole and Lapatinib in Postmenopausal Women With ER and Her2 Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • pCR [ Time Frame: 2010 Nov- 2012 May ] [ Designated as safety issue: Yes ]
    To evaluate the pathologic complete response (pCR) rate to lapatinib combined with letrozole in neoadjuvant setting


Secondary Outcome Measures:
  • SUV for [18F]FES PET [ Time Frame: 2010 Nov- 2012 May ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 32
Study Start Date: September 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275859

Contacts
Contact: Sung-Bae Kim, MD +82-2-3010-3217 sbkim3@amc.seoul.kr

Locations
Korea, Republic of
Asan Nedical Center Recruiting
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Sung-Bae Kim, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Sung-Bae Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01275859     History of Changes
Other Study ID Numbers: 2009-0729
Study First Received: January 12, 2011
Last Updated: November 19, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Neoadjuvant
Letrozole
Lapatinib
Postmenopausal

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Lapatinib
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014