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.
Verified July 2012 by Asan Medical Center
Sponsor:
Asan Medical Center
Information provided by (Responsible Party):
Sung-Bae Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01275859
First received: January 12, 2011
Last updated: July 27, 2012
Last verified: July 2012
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Purpose
Detailed Description:
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 2013 |
Estimated Primary Completion Date: | September 2012 (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:
|
Detailed 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.
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
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
Keywords provided by Asan Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
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: | July 27, 2012 |
Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Asan Medical Center:
Neoadjuvant Letrozole Lapatinib Postmenopausal |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Lapatinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on October 18, 2012