Breast CancerPhase 2Neo-All-InNCT01275859
Neoadjuvant Combined Endocrine and HER2 Target Therapy in Postmenopausal Women With ER and Her2 Positive Breast Cancer
A Phase 2 study testing Letrozole, Lapatinib in people with Breast Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Letrozole, Lapatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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:
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Letrozole and Lapatinib in Postmenopausal Women With ER and Her2 Positive Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Letrozole, Lapatinib
- Keywords
- Neoadjuvant, Letrozole, Lapatinib, Postmenopausal
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole, LapatinibDrug
Also called Femara, Tykerb
Letrozole 2.5mg po qd+ Lapatinib 1500mg po qd for 18-21 wks
| Study group | Role | What they receive |
|---|---|---|
| Letrozole, Lapatinib | Experimental | Letrozole 2.5mg po qd + Lapatinib 1500mg po qd for 18-21 wks Receives: Drug: Letrozole, Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
To evaluate the pathologic complete response (pCR) rate to lapatinib combined with letrozole in neoadjuvant setting
Measured: 2010 Nov- 2012 May
Secondary outcomes (1)
SUV for [18F]FES PET
- 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
Measured: 2010 Nov- 2012 May
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Bae Kim, Asan Medical Center
- Investigators
- Sung-Bae Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275859
- Sponsor's protocol ID
- 2009-0729
- Acronym
- Neo-All-In
- Status last verified
- Aug 2017
- First submitted
- 12 Jan 2011
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Letrozole and Lapatinib in Postmenopausal Women With ER and Her2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01275859
- Acronym / sponsor ID
- Neo-All-In / 2009-0729
- Conditions
- Breast Cancer
- Keywords
- Neoadjuvant, Letrozole, Lapatinib, Postmenopausal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole, Lapatinib | Experimental | Drug: Letrozole, LapatinibLetrozole 2.5mg po qd + Lapatinib 1500mg po qd for 18-21 wks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole, LapatinibAlso: Femara, TykerbLetrozole 2.5mg po qd+ Lapatinib 1500mg po qd for 18-21 wks | Drug | Letrozole, Lapatinib |
Primary outcome
pCR
Time frame: 2010 Nov- 2012 May
To evaluate the pathologic complete response (pCR) rate to lapatinib combined with letrozole in neoadjuvant setting
1 secondary outcome
SUV for [18F]FES PET
Time frame: 2010 Nov- 2012 May
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Bae Kim, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole, Lapatinib in people with Breast Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: 2010 Nov- 2012 May). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.