Clinical Trials /

1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.

NCT02000596

Description:

This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally advanced and/or metastatic breast carcinoma.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.
  • Official Title: 1303GCC: Phase II Study of Trastuzumab and Pertuzumab Alone and in Combination With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over With HER2/Neu Overexpressed Locally Advanced and/or Metastatic Breast Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: HP-00054959; 1303GCC
  • SECONDARY ID: GCC1303
  • NCT ID: NCT02000596

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
Trastuzumab plus PertuzumabCohort 1: T+P
Hormonal Therapy with Anastrozole and FulvestrantAnastrozole (Arimidex), Fulvestrant (Faslodex)Cohort 2 - Arm A
Chemotherapy with EribulinCohort 2 - Arm B

Purpose

This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally advanced and/or metastatic breast carcinoma.

Detailed Description

      Currently available standard therapies for HER2 overexpressed metastatic breast cancers (MBC)
      include treatments with chemotherapy or hormonal therapy, alone or in combination with
      medications that target HER2 gene, such as Trastuzumab or Pertuzumab. This study will examine
      the effect of treating HER2 overexpressed MBC with the combination of Trastuzumab plus
      Pertuzumab, without hormonal or chemotherapy, as a first line treatment. If patients progress
      on this treatment, they will receive hormonal or chemotherapy in addition to the Trastuzumab
      plus Pertuzumab treatment. The objective is to see how the overall response rate for this
      treatment compares to other first line treatments in the same patient population.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1: T+PExperimentalTrastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
  • Trastuzumab plus Pertuzumab
Cohort 2 - Arm AExperimentalHormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
  • Trastuzumab plus Pertuzumab
  • Hormonal Therapy with Anastrozole and Fulvestrant
Cohort 2 - Arm BExperimentalChemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
  • Trastuzumab plus Pertuzumab
  • Chemotherapy with Eribulin

Eligibility Criteria

        Inclusion Criteria:

          1. Women ≥60 Years of Age.

          2. Histologically confirmed, locally advanced (T4 primary tumor and stage IIIB or IIIC
             disease) or metastatic breast cancer that progressed after treatment with standard
             treatment regimens in the adjuvant or neoadjuvant setting.

          3. Prior treatment with trastuzumab and/or lapatinib in the neo-adjuvant or adjuvant
             setting is allowed but not required. Lapatininb has to be discontinued > 21 days
             before the initiation of the T+P study treatments.

          4. Up to 3 prior chemo regimens for treatment of metastatic disease are allowed as long
             as the study subject is acceptable for study treatment with chemo required on this
             study in cohort 2 at progression on T+P.

          5. Patients may have had prior hormonal therapy with any hormonal agents as per section
             3.1.5 of this protocol.

          6. Zometa or denosumab can be continued as per standard of care as long as started before
             the study treatment is started.

          7. HER2 positive breast cancer, as defined in Section 3.3 of this protocol

          8. Must have measurable or evaluable disease according to RECIST 1.1 criteria.

          9. Lab values obtained ≤7 days prior to registration as indicated in 3.1.9 of this
             protocol.

         10. ECOG Performance Status (PS) of 0, 1 or 2.

         11. LVEF at least 50% as determined by MUGA or ECHO.

         12. Life expectancy >3 months.

         13. Written informed consent.

         14. Willingness to return to study site for treatment and follow-up.

         15. Normal QTc interval defined on EKG as QTc ≤ 440 msec.

         16. Postmenopausal women defined in section 3.1.16 of this protocol.

        Exclusion Criteria:

          1. Stage III or IV cancer, other than breast cancer, in ≤5 years prior to registration.

          2. Actively being treated for other malignancy.

          3. New York Heart Association Class III or IV cardiovascular disease.

          4. History of coronary heart failure (CHF)

          5. Current use of drugs known to prolong the QTc interval including Class Ia and III
             antiarrhythmics or history of congenital long QTc syndrome.

          6. Evidence of active brain metastasis including leptomeningeal involvement.

          7. Major surgery, chemotherapy, hormonal or immunologic therapy ≤3 weeks prior to
             registration.

          8. Radiotherapy ≤3 weeks prior to registration, except if to a non-target lesion only.

          9. Prior treatment with Pertuzumab, Eribulin, Fulvestrant or Anastrozole.

         10. Uncontrolled illness.

         11. Co-morbid systemic illnesses or other severe concurrent disease. See section 3.2.11.

         12. Currently receiving treatment in a different clinical study in which investigational
             procedures are performed or investigational therapies are administered.

         13. Immunocompromised patients (other than that related to the use of corticosteroids)
             including patients known to be HIV positive.

         14. International normalized ratio (INR), activated partial thromboplastin time (aPTT) or
             partial thromboplastin time (PTT) >1.5 × ULN (unless on anticoagulation medication)

         15. Receipt of intravenous (IV) antibiotics for infection within 7 days prior to
             enrollment into the study.

         16. Current chronic daily treatment with corticosteroids. See section 3.2.16 of this
             protocol.

         17. Known hypersensitivity to any of the study treatments or to excipients of recombinant
             human or humanized antibodies.

         18. History of receiving any investigational treatment within 28 days prior to enrollment
             into the study.

         19. 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:60 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:ORR in T+P only
Time Frame:24 weeks
Safety Issue:
Description:Overall response rate (ORR) in patients with HER2+ MBC treated with Trastuzumab and Pertuzumab (T+P) alone (cohort 1). Defined as the total of complete response (CR) + partial response (PR) + stable disease (SD) >= 24 weeks over the total number of participants (ORR=[CR+PR+SD]/n) as defined by the Response Evaluation in Solid Tumors (RECIST) 1.1 response criteria.

Secondary Outcome Measures

Measure:Progression-free survival
Time Frame:every 12 weeks until progression of disease
Safety Issue:
Description:To assess Progression-free survival (PFS) and overall survival (OS) in treatment cohorts 1 and 2 as well as arms A and B
Measure:safety and tolerability
Time Frame:until progression of disease
Safety Issue:
Description:the safety and tolerability of Trastuzumab and Pertuzumab alone and in combination with hormonal therapy or single agent chemotherapy. in HER2+ MBC patients
Measure:quality of life
Time Frame:until progression of disease
Safety Issue:
Description:assess quality of life and treatment side effects via patient-reported and investigator reported outcomes

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Katherine Tkaczuk

Trial Keywords

  • HER2 overexpressed
  • Metastatic Breast Cancer
  • Elderly

Last Updated

February 5, 2018