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Not reveal any significant difference between the 2 treatment arms
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In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.
Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel-bevacizumab | Active Comparator | Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15 |
|
| exemestane-bevacizumab | Experimental | exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | IV, 80mg/m² at d1, d8, d15 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary free survival | 24 months for recruitment and 18 months for follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas BACHELOT, Md | GINECO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BACHELOT | Lyon | 69000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26916095 | Derived | Tredan O, Follana P, Moullet I, Cropet C, Trager-Maury S, Dauba J, Lavau-Denes S, Dieras V, Beal-Ardisson D, Gouttebel M, Orfeuvre H, Stefani L, Jouannaud C, Burki F, Petit T, Guardiola E, Becuwe C, Blot E, Pujade-Lauraine E, Bachelot T. A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study. Ann Oncol. 2016 Jun;27(6):1020-1029. doi: 10.1093/annonc/mdw077. Epub 2016 Feb 24. |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Bevacizumab |
| Drug |
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks |
|
| Exemestane | Drug | daily 25 mg (1 pill) oral intake |
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |