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Trial record 88 of 157 for:    eribulin

Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer (E-SPEC)

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ClinicalTrials.gov Identifier: NCT02551263
Recruitment Status : Active, not recruiting
First Posted : September 16, 2015
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Kyoto Breast Cancer Research Network
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief Summary:
This is a observational study in a real-world setting, not requiring determining a dosage regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose of the study is to investigate the efficacy of eribulin as the first or second line chemotherapy to prolong overall survival and to explore factors affecting the survival in patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who scheduled to receive the first or second line chemotherapy in clinical practice in Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year enrollment period and 3-year observational period; the duration of patient participation will be 3 years. All patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the Japanese Breast Cancer Society Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will enter patient data into an electronic data capture (EDC) system up to the third chemotherapy in the study. The end of the study is defined as the time the last patient completes observational period. Patients will primarily be assessed by overall survival (OS) of the first line chemotherapy.

Condition or disease Intervention/treatment
Breast Cancer Drug: Eribulin

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study to Explore the Efficacy of Eribulin as 1st-line or 2nd-line Chemotherapy in Patients With HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer
Actual Study Start Date : July 22, 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational group
All patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the Japanese Breast Cancer Society Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will enter patient data into an electronic data capture (EDC) system up to the third chemotherapy in the study.
Drug: Eribulin
Eribulin 1.4 mg/m2 will be administered intravenously over 2 to 5 minutes on day 1 and 8 of every 21-day cycle, in a real-world setting.




Primary Outcome Measures :
  1. Overall survival (OS) of the first line chemotherapy [ Time Frame: From starting date of the first line chemotherapy until date of death from any cause (up to 5 years) ]

Secondary Outcome Measures :
  1. Overall survival (OS) of the second and third line chemotherapy [ Time Frame: From starting date of each line of chemotherapy until date of death from any cause (up to 5 years) ]
  2. Progression-free survival (PFS) of the first, second and third line chemotherapy [ Time Frame: From starting date of each line of chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first (up to 5 years) ]
  3. Post progression survival (PPS) of the first, second and third line chemotherapy [ Time Frame: From the date of first documented disease progression in each line of chemotherapy until date of death from any cause (up to 5 years) ]
  4. Time to treatment failure (TTF) of the first, second and third line chemotherapy [ Time Frame: From starting date of each line of chemotherapy until date of discontinuation of study treatment for any reason including disease progression, treatment toxicity or death (up to 5 years) ]
  5. New metastasis-free survival (nMFS) of the first, second and third line chemotherapy [ Time Frame: From starting date of each line of chemotherapy until the date of first documented disease progression due to appearance of a new metastasis or date of death from any cause, whichever comes first (up to 5 years) ]
  6. Assessment and comparison of Quality Adjusted Life Years (QALYs) in the first, second and third line chemotherapy, using Japanese version of the EQ-5D-5L value set [ Time Frame: From date of the baseline QALYs assessment in each line of chemotherapy until the last date of each line of chemotherapy (up to 5 years) ]
  7. Serious adverse events [ Time Frame: Up to 5 years ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer, who are scheduled to receive the first or second line chemotherapy in clinical practice in Japan.
Criteria

Inclusion Criteria:

  1. Female patients with histologically or cytologically confirmed breast cancer.
  2. Patients with inoperable or recurrent metastatic breast cancer regardless of the metastatic site and number, excluding symptomatic central nervous system metastases.
  3. Patients with HER2-negative disease confirmed as ISH negative or IHC 0, 1+ or 2+ (Those with IHC 2+ are eligible, if the additional ISH test results are negative. Those are ineligible who are with any positive results of estrogen receptor or progesterone receptor test on primary and recurrent lesion).
  4. Patients who are resistant to hormone therapy.
  5. Patients with indication for the first or second line chemotherapy in HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who are scheduled to receive the chemotherapy.
  6. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status score 0-3 at the time of enrollment.
  7. Patients with adequate bone marrow and major organ function judged by the primary physician.
  8. Patients who have signed written informed consent to participate in this study.

Exclusion Criteria:

  1. Patients with symptomatic metastasis in the central nervous system.
  2. Patients with a previous history of hypersensitivity to any component of drugs which will be administered in the treatment.
  3. Patients who are considered to be inappropriate for the study participation by the primary physician.

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): NCT02551263


Locations
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Japan
Kobe City Medical Center General Hospital
Kobe-city, Hyogo-prefecture, Japan, 650-0047
Kyoto University Hospital
Kyoto-city, Kyoto-prefecture, Japan, 606-8507
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Kyoto Breast Cancer Research Network
Investigators
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Principal Investigator: Yuichiro Kikawa, MD Kobe City Medical Center General Hospital
Principal Investigator: Takeshi Kotake, MD Kyoto University

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Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT02551263     History of Changes
Other Study ID Numbers: TRIBC1505
UMIN000018178 ( Registry Identifier: UMIN-CTR )
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
Breast Cancer
Eribulin
HER2-negative
hormone-resistant
inoperable
recurrent metastatic

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs