NCT02411344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

3.9 years

First QC Date

March 5, 2015

Last Update Submit

September 17, 2018

Conditions

Endocrine Sensitive HER2+/HR+ Breast Cancer

Keywords

HER2+/HR+breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    At time of surgery, within 3 weeks from the last i.v. therapy

Secondary Outcomes (4)

  • Percentage of clinical objective response.

    At time of surgery, within 3 weeks from the last i.v. therapy

  • Rate of Conservative Surgery

    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

    Every 21-day cycles

  • Occurrence of mutations in the PIK3CA gene

    Within 4 weeks prior to first dose treatment

Study Arms (1)

Pertuzumab, Trastuzumab, Letrozole

EXPERIMENTAL
Drug: Pertuzumab

Interventions

PertuzumabDRUG

* 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).

Also known as: Perjeta
Pertuzumab, Trastuzumab, Letrozole

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Policlinico Vittorio Emanuele

Catania, CT, Italy

Location

Arcispedale S. Anna

Cona, FE, Italy

Location

Istituto Europeo di Oncologia

Milan, MI, Italy

Location

Istituto Nazionale Tumori

Milan, MI, Italy

Location

Ospedale "Guglielmo da Saliceto"

Piacenza, PC, Italy

Location

Istituto Oncologico Veneto, Oncologia Medica 2

Padua, PD, 35128, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, RE, Italy

Location

A. O. U. Santa Maria della Misericordia

Udine, UD, Italy

Location

Related Publications (1)

  • 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.

    PMID: 30778520DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Valentina Guarneri, MD; PhD

    Medical Oncology 2, Istituto Oncologico Veneto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 5, 2015

First Posted

April 8, 2015

Study Start

February 1, 2014

Primary Completion

January 12, 2018

Study Completion

January 12, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(8)