Endocrine Sensitive HER2+/HR+ Breast CancerPhase 2PER-ELISANCT02411344
Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy
A Phase 2 study testing Pertuzumab in people with Endocrine Sensitive HER2+/HR+ Breast Cancer, run by Istituto Oncologico Veneto IRCCS at 8 sites in Italy.
Trial summary
The purpose of this study is to evaluate the activity of molecular response in endocrine sensitive breast cancer HER2+/HR+ patients treated with Pertuzumab-trastuzumab plus Ietrozole. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endocrine Sensitive HER2+/HR+ Breast Cancer
- What is being tested?
- Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 8 sitesItaly
- Study dates
- Feb 2014to 12 Jan 2018
- 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
- primary diagnosis of infiltrating breast cancer
- HR positivity (ER ≥ 10% and/or PgR ≥10%) and HER2 positivity (IHC 3+ or FISH/CISH amplification), as assessed by local laboratory.
- Stage II-IIIA
- age >18 yrs
- ECOG Performance Status 0-1
- Postmenopausal status, defined by at least one of the following:
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- 60 years of age; < 60 years of age and amenorrheic for >/=12 months prior to day 1 < 60 years of age, without a uterus, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range Prior bilateral oophorectomy Prior radiation castration with amenorrhea for at least 6 months
- Cardiac ejection fraction within the institutional range of normal (as measured by echocardiogram or MUGA scan).
- Normal organ and marrow function as defined below:
- (leukocytes >=3000/mcL; absolute neutrophil count >=1,500/mcL; platelets >=100,000/mcL; total bilirubin within 1.25 x normal institutional limits (with the exception of Gilbert's syndrome); AST (SGOT)/ALT(SGPT) within 1.25 x institutional upper limit of normal creatinine within normal institutional limits
- Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Stage IIIB, IIIC, and inflammatory breast cancer
- Stage IV breast cancer
- Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with HER2 targeting therapies
- LVEF below the ULN
- Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA)/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) grade II or higher, or serious cardiac arrhythmia requiring medication.
- Received any investigational treatment within 4 weeks of study start.
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- Subjects with known infection with HIV, HBV, HCV
- Known hypersensitivity to any of the study drugs or excipients.
- Dyspnoea at rest or other disease requiring continuous oxygen therapy.
- Psychiatric illness/social situations that would limit compliance with study requirements
- Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Policlinico Vittorio Emanuele
Catania, CT
Arcispedale S. Anna
Cona, FE
Istituto Europeo di Oncologia
Milan, MI
Istituto Nazionale Tumori
Milan, MI
Istituto Oncologico Veneto, Oncologia Medica 2
Padova, PD, 35128
Ospedale "Guglielmo da Saliceto"
Piacenza, PC
Arcispedale S. Maria Nuova
Reggio Emilia, RE
A. O. U. Santa Maria della Misericordia
Udine, UD
About this study
Official title: PERtuzumab-trastuzumab Plus lEetrozoLe In Endocrine Sensitive Breast Cancer: a Phase II neoAdjuvant Study
The purpose of this study is to evaluate the activity of molecular response in endocrine sensitive breast cancer HER2+/HR+ patients treated with Pertuzumab-trastuzumab plus Ietrozole.
Read the detailed description
The purpose of this study is:
- to evaluate the rate of pathologic complete response (pCR), as defined as complete disappearance of invasive tumor in breast and axillary nodes.
- to estimate the percentage of clinical objective responses (cOR) (complete plus partial) in the breast, as assessed by ultrasonography (US)
- to estimate the percentage of breast conservative surgery
- to evaluate the safety profile
- To perform correlative biomarker analyses
- Being tested
- Pertuzumab
- Keywords
- HER2+/HR+, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PertuzumabDrug
Also called Perjeta
- Pertuzumab 840 mg loading dose iv on day one, followed by 420 mg iv every 3 weeks for 5 cycles
- Trastuzumab 8 mg/kg loading dose iv on day 2, followed by 6 mg/kg iv on day 2 of each subsequent 3 weekly cycle
- Letrozole 2.5 mg daily p.o. for five 21-day cycles (to be continued until surgery).
| Study group | Role | What they receive |
|---|---|---|
| Pertuzumab, Trastuzumab, Letrozole | Experimental | Not described Receives: Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pathologic complete response
A pathologic complete response (pCR) is defined the complete absence of infiltrating tumor cells in the breast and in lymph nodes. Residual in situ disease (DCIS) will be included in the pCR category.
Measured: At time of surgery, within 3 weeks from the last i.v. therapy
Secondary outcomes (4)
Percentage of clinical objective response.
The Clinical Response will be defined according to RECIST criteria comparing the tumor size (largest tumor diameter) before and after treatment, as assessed by ultrasound examination.
Measured: At time of surgery, within 3 weeks from the last i.v. therapy
Rate of Conservative Surgery
Measured: At time of surgery, within 3 weeks from the last i.v. therapy
Safety profile assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) To version 4.0 will be used
Measured: Every 21-day cycles
Occurrence of mutations in the PIK3CA gene
Measured: Within 4 weeks prior to first dose treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endocrine Sensitive HER2+/HR+ 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Association for Translational Research in Oncology (AS.T.R.O.)
- Responsible party
- Principal investigator, Valentina Guarneri, Istituto Oncologico Veneto IRCCS
- Investigators
- Valentina Guarneri, MD; PhD, Principal investigator, Medical Oncology 2, Istituto Oncologico Veneto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411344
- Sponsor's protocol ID
- AS.T.R.O.BC01-13
- Other IDs
- 2013-002662-40
- Acronym
- PER-ELISA
- Status last verified
- Sep 2018
- First submitted
- 5 Mar 2015
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guarneri V, Dieci MV, Bisagni G, Frassoldati A, Bianchi GV, De Salvo GL, Orvieto E, Urso L, Pascual T, Pare L, Galvan P, Ambroggi M, Giorgi CA, Moretti G, Griguolo G, Vicini R, Prat A, Conte PF. De-escalated therapy for HR+/HER2+ breast cancer patients with Ki67 response after 2-week letrozole: results of the PerELISA neoadjuvant study. Ann Oncol. 2019 Jun 1;30(6):921-926. doi: 10.1093/annonc/mdz055.
PubMed 30778520
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERtuzumab-trastuzumab Plus lEetrozoLe In Endocrine Sensitive Breast Cancer: a Phase II neoAdjuvant Study
- ClinicalTrials.gov ID
- NCT02411344
- Acronym / sponsor ID
- PER-ELISA / AS.T.R.O.BC01-13
- Keywords
- HER2+/HR+, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Collaborators
- Association for Translational Research in Oncology (AS.T.R.O.)
- Study start
- Feb 2014
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 8 Apr 2015 (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 the activity of molecular response in endocrine sensitive breast cancer HER2+/HR+ patients treated with Pertuzumab-trastuzumab plus Ietrozole.
Detailed description
The purpose of this study is:
- to evaluate the rate of pathologic complete response (pCR), as defined as complete disappearance of invasive tumor in breast and axillary nodes.
- to estimate the percentage of clinical objective responses (cOR) (complete plus partial) in the breast, as assessed by ultrasonography (US)
- to estimate the percentage of breast conservative surgery
- to evaluate the safety profile
- To perform correlative biomarker analyses
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pertuzumab, Trastuzumab, Letrozole | Experimental | Drug: Pertuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- primary diagnosis of infiltrating breast cancer
- HR positivity (ER ≥ 10% and/or PgR ≥10%) and HER2 positivity (IHC 3+ or FISH/CISH amplification), as assessed by local laboratory.
- Stage II-IIIA
- age >18 yrs
- ECOG Performance Status 0-1
Key exclusion criteria (11 listed)
- Stage IIIB, IIIC, and inflammatory breast cancer
- Stage IV breast cancer
- Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with HER2 targeting therapies
- LVEF below the ULN
- Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA)/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) grade II or higher, or serious cardiac arrhythmia requiring medication.
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 |
|---|---|---|
| PertuzumabAlso: Perjeta* Pertuzumab 840 mg loading dose iv on day one, followed by 420 mg iv every 3 weeks for 5 cycles * Trastuzumab 8 mg/kg loading dose iv on day 2, followed by 6 mg/kg iv on day 2 of each subsequent 3 weekly cycle * Letrozole 2.5 mg daily p.o. for five 21-day cycles (to be continued until surgery). | Drug | Pertuzumab, Trastuzumab, Letrozole |
Primary outcome
Rate of pathologic complete response
Time frame: At time of surgery, within 3 weeks from the last i.v. therapy
A pathologic complete response (pCR) is defined the complete absence of infiltrating tumor cells in the breast and in lymph nodes. Residual in situ disease (DCIS) will be included in the pCR category.
4 secondary outcomes
Percentage of clinical objective response.
Time frame: At time of surgery, within 3 weeks from the last i.v. therapy
Rate of Conservative Surgery
Time frame: At time of surgery, within 3 weeks from the last i.v. therapy
Safety profile assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) To version 4.0 will be used
Time frame: Every 21-day cycles
Occurrence of mutations in the PIK3CA gene
Time frame: Within 4 weeks prior to first dose treatment
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 18 Sep 2018.
- Derived from this study: PubMed 30778520Guarneri V, Dieci MV, Bisagni G, Frassoldati A, Bianchi GV, De Salvo GL, Orvieto E, Urso L, Pascual T, Pare L, Galvan P, Ambroggi M, Giorgi CA, Moretti G, Griguolo G, Vicini R, Prat A, Conte PF. De-escalated therapy for HR+/HER2+ breast cancer patients with Ki67 response after 2-week letrozole: results of the PerELISA neoadjuvant study. Ann Oncol. 2019 Jun 1;30(6):921-926. doi: 10.1093/annonc/mdz055.
- Individual participant dataSharing planned: No
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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.
Valentina Guarneri, MD; PhD principal investigator
Medical Oncology 2, Istituto Oncologico Veneto
8 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 Pertuzumab in people with Endocrine Sensitive HER2+/HR+ Breast Cancer, run by Istituto Oncologico Veneto IRCCS at 8 sites in Italy.
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 12 inclusion and 11 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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?
Rate of pathologic complete response (time frame: At time of surgery, within 3 weeks from the last i.v. therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02411344, which also lists 1 linked publication.
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 18 Sep 2018.