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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02015676 |
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Date of registration:
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03/12/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
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Scientific title:
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'A Study of the Effect of First Line Treatment With Paclitaxel and Myocet in Combination With Herceptin on Overall Tumor Response in Patients With Metastatic or Locally Advanced Breast Cancer and HER2 Overexpression.' |
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Date of first enrolment:
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July 2001 |
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Target sample size:
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69 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02015676 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- women 18-70 years of age;
- metastatic or locally advanced breast cancer;
- HER2 overexpression;
- >= 1 measurable lesion.
Exclusion Criteria:
- prior treatment for advanced breast cancer;
- prior treatment with Herceptin;
- bone or central nervous system metastasis as the only site of disease;
- history of another malignancy (except basal cell skin cancer and cancer in situ of the
uterine cervix, and contralateral breast cancer) within 5 years of study.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: paclitaxel
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Drug: Myocet
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Drug: trastuzumab
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Primary Outcome(s)
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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
[Time Frame: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Secondary Outcome(s)
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Overall Survival
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Duration of Response
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Time to Treatment Response
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Time to Disease Progression
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Time to Therapy Failure
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Time to Therapy Failure - Percentage of Participants With an Event
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Time to Disease Progression - Percentage of Participants With an Event
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Time to Treatment Response - Percentage of Participants With an Event
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Overall Survival (OS) - Percentage of Participants With an Event
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Duration of Response - Percentage of Participants With an Event
[Time Frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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