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Sponsored by: |
Finnish Breast Cancer Group |
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Information provided by: | Finnish Breast Cancer Group |
ClinicalTrials.gov Identifier: | NCT00593697 |
The purpose of the study is to compare disease-free survival (DFS) of women treated with concomitant trastuzumab plus docetaxel followed by FEC to that of the women treated with the same regimen followed by single-agent trastuzumab to complete one year of trastuzumab administration as adjuvant treatments of early HER2-positive breast cancer.
Condition | Intervention | Phase |
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Breast Neoplasms |
Drug: trastuzumab (9 weeks) + docetaxel Drug: trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase III Study Comparing Trastuzumab Plus Docetaxel (HT) Followed by 5-FU, Epirubicin, and Cyclophosphamide (FEC) to the Same Regimen Followed by Single-Agent Trastuzumab as Adjuvant Treatments for Early Breast Cancer |
Estimated Enrollment: | 3000 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) (HT x3 -> FE75C x3)
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Drug: trastuzumab (9 weeks) + docetaxel
Patients diagnosed with early breast cancer with a high risk of disease recurrence will be randomly allocated to one of the following 2 arms in a 1:1 ratio: A. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) (HT x3 ->FE75C x3) B. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14) |
B: Active Comparator
Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14)
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Drug: trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks)
Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A high risk of breast cancer recurrence with one of the following:
Exclusion Criteria:
One or more of the following:
Contact: Heikki Joensuu, MD | +358 09 4711 | heikki.joensuu@hus.fi |
Contact: Riikka Huovinen, MD | +358 02 313 0000 | riikka.huovinen@tyks.fi |
Finland | |
Helsinki University Central Hospital, Department of Oncology | Recruiting |
Helsinki, Finland, 00029 HUS | |
Contact: Heikki Joensuu, MD +358 09 4711 heikki.joensuu@hus.fi | |
Contact: Riikka Huovinen, MD +358 02 313 0000 riikka.huovinen@tyks.fi | |
Principal Investigator: Heikki Joensuu, MD |
Responsible Party: | Department of Oncology, Helsinki University Central Hospital ( Principal Investigator: Heikki Joensuu ) |
Study ID Numbers: | Protocol number FBCSG-01-2007, EudraCT number 2007-002016-26 |
Study First Received: | January 3, 2008 |
Last Updated: | January 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00593697 |
Health Authority: | Finland: National Agency for Medicines |
breast cancer adjuvant therapy trastuzumab chemotherapy |
Docetaxel Skin Diseases Fluorouracil Trastuzumab |
Breast Neoplasms Cyclophosphamide Epirubicin Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |