Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial
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ClinicalTrials.gov Identifier: NCT02181101 |
Recruitment Status :
Completed
First Posted : July 3, 2014
Last Update Posted : July 3, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | June 4, 2014 | |||
First Posted Date ICMJE | July 3, 2014 | |||
Last Update Posted Date | July 3, 2014 | |||
Study Start Date ICMJE | September 2005 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Disease free survival [ Time Frame: 5 years ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(Doc)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DocGemzar)-chemotherapy, and to compare the disease free survival after randomisation in patients treated with 2 years of Zoledronate versus 5 years of Zoledronate in patients with early primary breast cancer. Patients will be required to have histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: 'pT≥2 or histopathological grade 3, or age ≤ 35 or negative hormone receptor', but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study. After surgery, leading to R0 resection of the invasive and intraductal components of the primary tumor, patients will be randomized to one of the following treatments: First randomization AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (Doc), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (Gemzar), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22 AB: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (Doc), administered on day 1, repeated on day 22 Second randomization B BA: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years, subsequently followed by zoledronic acid 4 mg i.v., every 6 months for the duration of additional three years BB: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years During the zoledronic acid treatment period, patients will receive 500 mg Calcium p.o. qid and 400 i.E. Vitamin D p.o. qid. Patients with positive hormone receptor status (≥ 10 % positively stained cells for estrogen and/or progesterone) of the primary tumor will receive Tamoxifen treatment 20 mg p.o. per day for 2 years, after the end of chemotherapy. Subsequent to chemotherapy, postmenopausal patients with positive hormone receptor status will be treated with Anastrozole (Arimidex®) 1 mg p.o. for additional 3 years, premenopausal patients will continue Tamoxifen treatment for additional 3 years. In addition to tamoxifen, all patients with positive hormone receptor status of the primary tumor and under the age of 40 or restart of menstrual bleeding within 6 months after the completion of cytostatic treatment or with premenopausal hormone levels as defined below will receive Goserelin (Zoladex®) 3.6 mg subcutaneously every 4 weeks over a period of 2 years following chemotherapy. Premenopausal endocrine status will be assumed, if the following serum levels are met: Luteinizing hormone (LH) < 20 mIE/ml, follicle stimulating hormone (FSH) < 20 mIE/ml and estradiol (E2) > 20 pg/ml. Endocrine therapy will start after the end of chemotherapy. All patients with breast conserving therapy or more than 3 axillary lymph node metastases or in the following cases after mastectomy:
will receive adjuvant radiotherapy. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Neoplasms | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
3754 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2013 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 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 | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02181101 | |||
Other Study ID Numbers ICMJE | SUCCESS-A 2005-000490-21 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Prof. Dr. med. Harald Leo Sommer, Ludwig-Maximilians - University of Munich | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Ludwig-Maximilians - University of Munich | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Ludwig-Maximilians - University of Munich | |||
Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |