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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02411344
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : September 18, 2018
Association for Translational Research in Oncology (AS.T.R.O.)
Information provided by (Responsible Party):
Valentina Guarneri, Istituto Oncologico Veneto IRCCS

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.

Condition or disease Intervention/treatment Phase
Endocrine Sensitive HER2+/HR+ Breast Cancer Drug: Pertuzumab Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PERtuzumab-trastuzumab Plus lEetrozoLe In Endocrine Sensitive Breast Cancer: a Phase II neoAdjuvant Study
Study Start Date : February 2014
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pertuzumab, Trastuzumab, Letrozole Drug: Pertuzumab
  • 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).
Other Name: Perjeta

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Percentage of clinical objective response. [ Time Frame: At time of surgery, within 3 weeks from the last i.v. therapy ]
    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.

  2. Rate of Conservative Surgery [ Time Frame: At time of surgery, within 3 weeks from the last i.v. therapy ]
  3. 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 ]
  4. Occurrence of mutations in the PIK3CA gene [ Time Frame: Within 4 weeks prior to first dose treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02411344

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Policlinico Vittorio Emanuele
Catania, CT, Italy
Arcispedale S. Anna
Cona, FE, Italy
Istituto Europeo di Oncologia
Milano, MI, Italy
Istituto Nazionale Tumori
Milano, MI, Italy
Ospedale "Guglielmo da Saliceto"
Piacenza, PC, Italy
Istituto Oncologico Veneto, Oncologia Medica 2
Padova, PD, Italy, 35128
Arcispedale S. Maria Nuova
Reggio Emilia, RE, Italy
A. O. U. Santa Maria della Misericordia
Udine, UD, Italy
Sponsors and Collaborators
Istituto Oncologico Veneto IRCCS
Association for Translational Research in Oncology (AS.T.R.O.)
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Principal Investigator: Valentina Guarneri, MD; PhD Medical Oncology 2, Istituto Oncologico Veneto
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Valentina Guarneri, MD, PhD, Istituto Oncologico Veneto IRCCS Identifier: NCT02411344    
Other Study ID Numbers: AS.T.R.O.BC01-13
2013-002662-40 ( EudraCT Number )
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Valentina Guarneri, Istituto Oncologico Veneto IRCCS:
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents