Clinical Trials /

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

NCT02411344

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Patients With Breast Cancer Sensitive to Hormonal Therapy
  • Official Title: PERtuzumab-trastuzumab Plus lEetrozoLe In Endocrine Sensitive Breast Cancer: a Phase II neoAdjuvant Study

Clinical Trial IDs

  • ORG STUDY ID: AS.T.R.O.BC01-13
  • SECONDARY ID: 2013-002662-40
  • NCT ID: NCT02411344

Conditions

  • Endocrine Sensitive HER2+/HR+ Breast Cancer

Interventions

DrugSynonymsArms
PertuzumabPerjetaPertuzumab, Trastuzumab, Letrozole

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
Pertuzumab, Trastuzumab, LetrozoleExperimental
  • Pertuzumab

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Rate of pathologic complete response
Time Frame:At time of surgery, within 3 weeks from the last i.v. therapy
Safety Issue:
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.

Secondary Outcome Measures

Measure:Percentage of clinical objective response.
Time Frame:At time of surgery, within 3 weeks from the last i.v. therapy
Safety Issue:
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.
Measure:Rate of Conservative Surgery
Time Frame:At time of surgery, within 3 weeks from the last i.v. therapy
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Occurrence of mutations in the PIK3CA gene
Time Frame:Within 4 weeks prior to first dose treatment
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Istituto Oncologico Veneto IRCCS

Trial Keywords

  • HER2+/HR+
  • breast cancer

Last Updated

September 16, 2016