Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT02000596
Recruitment Status : Terminated (funding withdrawn by sponsor)
First Posted : December 4, 2013
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Katherine Tkaczuk, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE December 4, 2013
Last Update Posted Date February 7, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • ORR in T+P only [ Time Frame: 24 weeks ]
    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.
  • ORR in T+P plus hormonal therapy (HT) [ Time Frame: 24 weeks ]
    Overall response rate (ORR) in patients with HER2+ ER and/or PR > 1% positive MBC with T+P+ Hormonal therapy ( Anastrozole+ Fulvestrant) after progression on T+P alone (Cohort 2-ArmA). 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 RECIST 1.1 response criteria.
  • ORR in T+P plus chemotherapy with Eribulin [ Time Frame: 24 weeks ]
    Overall response rate (ORR) in patients with HER2+, ER/PR negative MBC with T+P+ Eribulin (Cohort 2 - arm-B) after progression on T+P alone. ORR 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 RECIST 1.1 response criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • Progression-free survival [ Time Frame: every 12 weeks until progression of disease ]
    To assess Progression-free survival (PFS) and overall survival (OS) in treatment cohorts 1 and 2 as well as arms A and B
  • safety and tolerability [ Time Frame: until progression of disease ]
    the safety and tolerability of Trastuzumab and Pertuzumab alone and in combination with hormonal therapy or single agent chemotherapy. in HER2+ MBC patients
  • quality of life [ Time Frame: until progression of disease ]
    assess quality of life and treatment side effects via patient-reported and investigator reported outcomes
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.
Official Title  ICMJE 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
Brief Summary 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Trastuzumab plus Pertuzumab
  • Drug: Hormonal Therapy with Anastrozole and Fulvestrant
    Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
    Other Names:
    • Anastrozole (Arimidex)
    • Fulvestrant (Faslodex)
  • Drug: Chemotherapy with Eribulin
Study Arms  ICMJE
  • Experimental: Cohort 1: T+P
    Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
    Intervention: Drug: Trastuzumab plus Pertuzumab
  • Experimental: Cohort 2 - Arm A
    Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
    Interventions:
    • Drug: Trastuzumab plus Pertuzumab
    • Drug: Hormonal Therapy with Anastrozole and Fulvestrant
  • Experimental: Cohort 2 - Arm B
    Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
    Interventions:
    • Drug: Trastuzumab plus Pertuzumab
    • Drug: Chemotherapy with Eribulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 1, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
60
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000596
Other Study ID Numbers  ICMJE HP-00054959; 1303GCC
GCC1303 ( Other Identifier: University of Maryland Greenebaum Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Katherine Tkaczuk, University of Maryland, College Park
Study Sponsor  ICMJE Katherine Tkaczuk
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Katherine Tkaczuk, MD University of Maryland Greenebaum Cancer Center
PRS Account University of Maryland, Baltimore
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP