Breast CancerPhase 2HERAKLESNCT02214004
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
A Phase 2 study testing Trastuzumab and Letrozole in people with Breast Cancer, run by Gangnam Severance Hospital at 14 sites in South Korea.
Trial summary
The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and HER2-positive breast cancer. 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?
- Trastuzumab and Letrozole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Mar 2015to Jun 2019
- 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
- Invasive cancer (clinical stage IB-IIIC)
- Measurable tumor larger than 1cm
- ECOG status 0 or 1
- Postmenopausal women
- Age ≥55 years and amenorrhea
- Age <55 years and amenorrhea for ≥12 months with FSH >30 mIU/ml
Show all 15Show fewer
- HER2 positive tumor
- 3 positive on IHC
- 2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
- Estrogen receptor positive tumor
- Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7
- Eligible cardiac function
- Normal heard evaluated by ECG
- Consider clinically non-significant arrythmia and ischemic change as normal
- LVEF ≥ 55% measured by ECHO or MUGA scan
Who cannot join
- Inflammatory breast cancer
- Bilateral breast cancer
- Patients with previous breast cancer history
- Patients with previous breast cancer treatment: Generally include hormone therapy, chemotherapy, and radiotherapy)
- Patients having uncontrolled heart problems
- Ischemic heart disease within 6 months
Show all 10Show fewer
- Congestive heart failure more than NYHA class II
- Unstable angina
- Clinically significant pericarditis
- Amyloid heart disease
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites, 14 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang
Lee Su Kim, M.D.,Ph.D., lskim0503@hallym.ac.kr
- Not yet recruiting
Inje University Pusan Paik Hospital
Busan
Taehyun Kim, M.D.,Ph.D.
- Recruiting
Dankook University Hospital
Cheonan
Junwon Min, M.D.,Ph.D.
- Recruiting
Ilsan Paik Hospital
Goyang
Jae Il Kim, M.D., Ph.D., erythrokim@paik.ac.kr
- Not yet recruiting
National Cancer Center
Goyang
Eun Sook Lee, M.D.,Ph.D., eslee@ncc.re.kr
- Recruiting
Gangnam Severance Hospital
Seoul, 135720
Joon Jeong, M.D.,Ph.D., 82220193370, gsjjoon@yuhs.ac
Sung Gwe Ahn, M.D., 82220193370, asg2004@yuhs.ac
- Not yet recruiting
Asan Medical Center
Seoul
Byung Ho Son, M.D.,Ph.D.
- Recruiting
Kangbuk Samsung Hospital
Seoul
Chan Heun Park, M.D.,Ph.D., chanheun.park@samsung.com
- Recruiting
Korea Institute of Radiological and Medical Sciences
Seoul
Woo Chul Noh, M.D.,Ph.D., 8229701280, nohwoo@kcch.re.kr
- Recruiting
Korea University Anam Hospital
Seoul
Jeoung Won Bae, M.D.,Ph.D.
- Not yet recruiting
Samsung Medical Center
Seoul
Seok Jin Nam, M.D.,Ph.D., seokjin.nam@samsung.com
- Recruiting
Seoul Medical Center
Seoul
Dong Hui Cho
- Recruiting
Seoul National University Hospital
Seoul
Wonshik Han, M.D.,Ph.D., hanw@snu.ac.kr
- Not yet recruiting
Ajou University School of Medicine
Suwon
Yongsik Jung, M.D.,Ph.D., drjys@ajou.ac.kr
About this study
Official title: A Phase II Trial of Preoperative HER2 Targeting and Endocrine Therapy in Postmenopausal Women With HER2 and HR Positive Breast Cancer
The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and HER2-positive breast cancer.
Read the detailed description
Eligibility criteria
- Ages Eligible for Study: ≥ 20 years
- Invasive cancer (clinical stage IB-IIIB)
- Measurable tumor larger than 1cm
- ECOG status 0 or 1
- Postmenopausal women
- Age ≥55 years and amenorrhea
- Age <55 years and amenorrhea for ≥12 months with FSH >30 mIU/ml
- HER2 positive tumor
- 3 positive on IHC
- 2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
- Estrogen receptor positive tumor
- Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7
- Eligible cardiac function
- Normal heard evaluated by ECG
- Consider clinically non-significant arrythmia and ischemic change as normal
- LVEF ≥ 55% measured by ECHO or MUGA scan
Outcome measures
- Primary End-point
- The rate of pathologic complete response (pCR)
- No residual invasive cancer in breast
- Secondary End-point
- Clinical Response Rate
- Safety profiles for the preoperative use of concurrent trastuzumab and letrozole
- The rate of breast conservative surgery
- Total pathologic complete response (tpCR)
- No residual invasive cancer in breast and ipsilateral axilla
- Analysis of biomarkers based on baseline specimen and residual tumor
- Ki67 expression
- cDNA microarray: gene expression profiling
- Association between clinical response rate and circulating tumor cells (CTCs)
- CTCs are measured by CytoGen (SEOUL, KOREA)"
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab, Letrozole
- Keywords
- Breast cancer, HER2, ER, Postmenopausal, Trastuzumab, Letrozole, Neoadjuvant endocrine treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Herceptin
- Eight times IV administration of trastuzumab per 3 weeks
- Trastuzumab 8mg/kg on Day 1 of Cycle 1
- Trastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8
LetrozoleDrug
Also called Femara
- Daily letrozole 2.5 mg/day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab and Letrozole | Experimental | - Concurrently initiate two drugs on Day 1 of Cycle 1 Receives: Drug: Trastuzumab; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of pathologic complete response
No residual invasive cancer in breast regardless of axilla
Measured: At time of surgery
Secondary outcomes (6)
Clinical Response Rate
Clinical response includes complete response, partial response and stable disease.
Measured: At time of surgery
Safety profiles for the preoperative use of concurrent trastuzumab and letrozole
Toxicity according to CTCAE protocol from the initiated day to 3 months after surgery
Measured: Up to 3 months after surgery
The rate of breast conservative surgery
The rate of breast conservative surgery among the patients receiving surgery
Measured: Up to 3 weeks after surgery
Total pathologic complete response (tpCR)
No residual invasive cancer in breast and ipsilateral axilla
Measured: At time of surgery
Analysis of biomarkers based on baseline specimen and residual tumor
- Ki67 expression
- cDNA microarray: gene expression profiling
Measured: Baseline and at time of surgery
Association between clinical response rate and circulating tumor cells (CTCs)
Association between clinical response rate and circulating tumor cells (CTCs)
: CTCs are measured by CytoGen (SEOUL, KOREA)"
Measured: Baseline and at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startMar 2015
- Primary completionMar 2019 (estimated)
- Study completionJun 2019 (estimated)
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.
- 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Severance Hospital, Samsung Medical Center, Asan Medical Center
- Responsible party
- Principal investigator, Joon Jeong, Gangnam Severance Hospital
- Investigators
- Joon Jeong, M.D.,Ph.D., Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214004
- Sponsor's protocol ID
- HERAKLES
- Acronym
- HERAKLES
- Status last verified
- Feb 2018
- First submitted
- 5 Aug 2014
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Preoperative HER2 Targeting and Endocrine Therapy in Postmenopausal Women With HER2 and HR Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT02214004
- Acronym / sponsor ID
- HERAKLES / HERAKLES
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, HER2, ER, Postmenopausal, Trastuzumab, Letrozole, Neoadjuvant endocrine treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Severance Hospital, Samsung Medical Center, Asan Medical Center
- Study start
- Mar 2015
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 12 Aug 2014 (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.
The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and HER2-positive breast cancer.
Detailed description
Eligibility criteria
- Ages Eligible for Study: ≥ 20 years
- Invasive cancer (clinical stage IB-IIIB)
- Measurable tumor larger than 1cm
- ECOG status 0 or 1
- Postmenopausal women
- Age ≥55 years and amenorrhea
- Age <55 years and amenorrhea for ≥12 months with FSH >30 mIU/ml
- HER2 positive tumor
- 3 positive on IHC
- 2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
- Estrogen receptor positive tumor
- Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7
- Eligible cardiac function
- Normal heard evaluated by ECG
- Consider clinically non-significant arrythmia and ischemic change as normal
- LVEF ≥ 55% measured by ECHO or MUGA scan
Outcome measures
- Primary End-point
- The rate of pathologic complete response (pCR)
- No residual invasive cancer in breast
- Secondary End-point
- Clinical Response Rate
- Safety profiles for the preoperative use of concurrent trastuzumab and letrozole
- The rate of breast conservative surgery
- Total pathologic complete response (tpCR)
- No residual invasive cancer in breast and ipsilateral axilla
- Analysis of biomarkers based on baseline specimen and residual tumor
- Ki67 expression
- cDNA microarray: gene expression profiling
- Association between clinical response rate and circulating tumor cells (CTCs)
- CTCs are measured by CytoGen (SEOUL, KOREA)"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab and Letrozole | Experimental | Drug: Trastuzumab, Drug: Letrozole- Concurrently initiate two drugs on Day 1 of Cycle 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Invasive cancer (clinical stage IB-IIIC)
- Measurable tumor larger than 1cm
- ECOG status 0 or 1
- Postmenopausal women
- HER2 positive tumor
Key exclusion criteria (10 listed)
- Inflammatory breast cancer
- Bilateral breast cancer
- Patients with previous breast cancer history
- Patients with previous breast cancer treatment: Generally include hormone therapy, chemotherapy, and radiotherapy)
- Patients having uncontrolled heart problems
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 |
|---|---|---|
| TrastuzumabAlso: Herceptin- Eight times IV administration of trastuzumab per 3 weeks * Trastuzumab 8mg/kg on Day 1 of Cycle 1 * Trastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8 | Drug | Trastuzumab and Letrozole |
| LetrozoleAlso: Femara- Daily letrozole 2.5 mg/day for 24 weeks | Drug | Trastuzumab and Letrozole |
Primary outcome
The rate of pathologic complete response
Time frame: At time of surgery
No residual invasive cancer in breast regardless of axilla
6 secondary outcomes
Clinical Response Rate
Time frame: At time of surgery
Safety profiles for the preoperative use of concurrent trastuzumab and letrozole
Time frame: Up to 3 months after surgery
The rate of breast conservative surgery
Time frame: Up to 3 weeks after surgery
Total pathologic complete response (tpCR)
Time frame: At time of surgery
Analysis of biomarkers based on baseline specimen and residual tumor
Time frame: Baseline and at time of surgery
Association between clinical response rate and circulating tumor cells (CTCs)
Time frame: Baseline and at time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Joon Jeong, M.D.,Ph.D. principal investigator
Gangnam Severance Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab and Letrozole in people with Breast Cancer, run by Gangnam Severance Hospital at 14 sites 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 15 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joon Jeong, M.D.,Ph.D. (82220193370, gsjjoon@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of pathologic complete response (time frame: At time of surgery). 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 15 Feb 2018.