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This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin + Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85). After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. During this period participants will be evaluated once a year on the anniversary date of randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-Fluorouracil + Epirubicin + Cyclophosphamide | Active Comparator | Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of 5-FU + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel. |
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| Capecitabine + Epirubicin + Cyclophosphamide | Experimental | Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of capecitabine + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | Drug | 5-FU will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle during neoadjuvant treatment period for 4 cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\n | Day 120 +/- 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification | Day 120 +/- 7 days | |
| Percentage of participants with breast conserving surgery | Day 120 +/- 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayonne | 64100 | France | ||||
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| Capecitabine | Drug | Capecitabine will be administered at 900 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle for 4 cycles during neoadjuvant treatment period. |
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| Cyclophosphamide | Drug | Cyclophosphamide will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period. |
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| Docetaxel | Drug | Docetaxel will be administered at 100 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period. |
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| Epirubicin | Drug | Epirubicin will be administered at 100 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period. |
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| Percentage of participants with objective clinical response, assessed by World Health Organization (WHO) criteria | Week 15 |
| Percentage of participants with clinical response, assessed by WHO criteria | Week 15 |
| Percentage of participants with disease progression, assessed by WHO criteria | Baseline up to 29 +/- 1 weeks |
| Percentage of participants with abnormalities in bilateral mammography | Day 85 |
| Percentage of participants who died | Baseline up to 29 +/- 1 weeks |
| Percentage of participants with abnormal left ventricular ejection fraction (LVEF) | Days 1-85 |
| Percentage of participants with abnormal liver ultrasound | Days 1-85 |
| Percentage of participants with abnormal Chest X-Ray | Days 1-85 |
| Overall survival | Baseline up to 5 years |
| Disease free survival, according to WHO criteria | Baseline up to 5 years |
| Béziers |
| 34500 |
| France |
| Bourg-en-Bresse | 01012 | France |
| Colmar | 68024 | France |
| Dijon | 21079 | France |
| Hyères | 83400 | France |
| La Tronche | 38700 | France |
| Le Mans | 72037 | France |
| Limoges | 87042 | France |
| Lyon | 69437 | France |
| Marseille | 13385 | France |
| Montbéliard | 25209 | France |
| Montfermeil | 93370 | France |
| Nice | 06189 | France |
| Nîmes | 30029 | France |
| Paris | 75181 | France |
| Pierre-Bénite | 69310 | France |
| Saint-Herblain | 44805 | France |
| Strasbourg | 67010 | France |
| Toulouse | 31059 | France |
| Vannes | 56001 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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