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Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy (PER-ELISA)

Primary Purpose

Endocrine Sensitive HER2+/HR+ Breast Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Pertuzumab
Sponsored by
Istituto Oncologico Veneto IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endocrine Sensitive HER2+/HR+ Breast Cancer focused on measuring HER2+/HR+, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    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

Exclusion Criteria:

  • 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.
  • 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

Sites / Locations

  • Policlinico Vittorio Emanuele
  • Arcispedale S. Anna
  • Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori
  • Ospedale "Guglielmo da Saliceto"
  • Istituto Oncologico Veneto, Oncologia Medica 2
  • Arcispedale S. Maria Nuova
  • A. O. U. Santa Maria della Misericordia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pertuzumab, Trastuzumab, Letrozole

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Rate of Conservative Surgery
Safety profile assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) To version 4.0 will be used
Occurrence of mutations in the PIK3CA gene

Full Information

First Posted
March 5, 2015
Last Updated
September 17, 2018
Sponsor
Istituto Oncologico Veneto IRCCS
Collaborators
Association for Translational Research in Oncology (AS.T.R.O.)
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1. Study Identification

Unique Protocol Identification Number
NCT02411344
Brief Title
Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy
Acronym
PER-ELISA
Official Title
PERtuzumab-trastuzumab Plus lEetrozoLe In Endocrine Sensitive Breast Cancer: a Phase II neoAdjuvant Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 12, 2018 (Actual)
Study Completion Date
January 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Oncologico Veneto IRCCS
Collaborators
Association for Translational Research in Oncology (AS.T.R.O.)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine Sensitive HER2+/HR+ Breast Cancer
Keywords
HER2+/HR+, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pertuzumab, Trastuzumab, Letrozole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta
Intervention Description
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).
Primary Outcome Measure Information:
Title
Rate of pathologic complete response
Description
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.
Time Frame
At time of surgery, within 3 weeks from the last i.v. therapy
Secondary Outcome Measure Information:
Title
Percentage of clinical objective response.
Description
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.
Time Frame
At time of surgery, within 3 weeks from the last i.v. therapy
Title
Rate of Conservative Surgery
Time Frame
At time of surgery, within 3 weeks from the last i.v. therapy
Title
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
Title
Occurrence of mutations in the PIK3CA gene
Time Frame
Within 4 weeks prior to first dose treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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 Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Guarneri, MD; PhD
Organizational Affiliation
Medical Oncology 2, Istituto Oncologico Veneto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Vittorio Emanuele
City
Catania
State/Province
CT
Country
Italy
Facility Name
Arcispedale S. Anna
City
Cona
State/Province
FE
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
State/Province
MI
Country
Italy
Facility Name
Istituto Nazionale Tumori
City
Milano
State/Province
MI
Country
Italy
Facility Name
Ospedale "Guglielmo da Saliceto"
City
Piacenza
State/Province
PC
Country
Italy
Facility Name
Istituto Oncologico Veneto, Oncologia Medica 2
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
State/Province
RE
Country
Italy
Facility Name
A. O. U. Santa Maria della Misericordia
City
Udine
State/Province
UD
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30778520
Citation
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.
Results Reference
derived

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Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy

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