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Trial record 74 of 173 for:    pertuzumab

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

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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Recruitment Status : Terminated (funding withdrawn by sponsor)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

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Trastuzumab plus Pertuzumab Drug: Hormonal Therapy with Anastrozole and Fulvestrant Drug: Chemotherapy with Eribulin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Cohort 1: T+P
Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
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 +
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)

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 -
Drug: Trastuzumab plus Pertuzumab
Drug: Chemotherapy with Eribulin



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. quality of life [ Time Frame: until progression of disease ]
    assess quality of life and treatment side effects via patient-reported and investigator reported outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02000596


Locations
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United States, Maryland
University of Maryland Marlene & Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Katherine Tkaczuk
Genentech, Inc.
Investigators
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Principal Investigator: Katherine Tkaczuk, MD University of Maryland Greenebaum Cancer Center

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Responsible Party: Katherine Tkaczuk, Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02000596     History of Changes
Other Study ID Numbers: HP-00054959; 1303GCC
GCC1303 ( Other Identifier: University of Maryland Greenebaum Cancer Center )
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Keywords provided by Katherine Tkaczuk, University of Maryland, College Park:
HER2 overexpressed
Metastatic Breast Cancer
Elderly
Additional relevant MeSH terms:
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Pertuzumab
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Fulvestrant
Anastrozole
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action