BIG 02/98 Docetaxel - Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00174655|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 10, 2011
- To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes.
- To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes
- To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes
- To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus polychemotherapy).
- To compare overall survival of treatment arms.
- To compare toxicity of treatment arms.
- To evaluate pathologic and molecular markers for predicting efficacy.
- Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Doxorubicine + docetaxel sequential Drug: doxorubicine + cyclophosphamide sequential Drug: doxorubicine + cyclophosphamide combined Drug: doxorubicine + docetaxel combined||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2887 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Intergroup Phase III Trial to Evaluate the Activity of Docetaxel, Given Either Sequentially or in Combination With Doxorubicin, Followed by CMF, in Comparison to Doxorubicin Alone or in Combination With Cyclophosphamide, Followed by CMF, in the Adjuvant Treatment of Node-positive Breast Cancer Patients.|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
|Active Comparator: A1||
Drug: doxorubicine + cyclophosphamide sequential
doxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles
|Active Comparator: A2||
Drug: doxorubicine + cyclophosphamide combined
doxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
Drug: Doxorubicine + docetaxel sequential
doxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles
Drug: doxorubicine + docetaxel combined
doxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
- DFS of docetaxel arms versus non toxanes arm (DFS: interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death for any cause whichever occurs first. [ Time Frame: 810 events or median 5 year follow-up whichever occurs first ]
- DFS sequential/combined arms [ Time Frame: 810 events or median 5 year follow-up whichever occurs first ]
- Safety NCI common toxicity criteria [ Time Frame: from baseline to study end ]
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): NCT00174655
|Macquarie Park, Australia|
|Sao Paulo, Brazil, ao|
|Providencia Santiago, Chile|
|Praha, Czech Republic|
|Auckland, New Zealand|
|Porto Salvo, Portugal|
|Gauteng, South Africa|
|Guildford Surrey, United Kingdom|
|Study Director:||Jean-Philippe Aussel||Sanofi|