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Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.
Patients with locally advanced breast cancer and patients with metastatic breast cancer who have not previously received an anthracycline will be treated with docetaxel and epirubicin.
Patients with metastatic breast cancer who have already received anthracyclines will be treated with docetaxel and capecitabine.
All patients will be randomized to receive their treatment either on an every three week schedule, or on a weekly schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Three-weekly chemotherapy |
|
| B | Experimental | Weekly chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | given in combination with epirubicin or capecitabine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | during first 6 weeks of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | After 12 and 24 weeks of chemotherapy | |
| Toxicity | every 3 weeks | |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea de Matteis, M.D. | NCI Naples, Division of Medical Oncology C | Principal Investigator |
| Francesco Perrone, M.D., Ph.D. | NCI Naples, Clinical Trials Office | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B | Naples | 80131 | Italy | |||
| Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21324184 | Result | Nuzzo F, Morabito A, Gravina A, Di Rella F, Landi G, Pacilio C, Labonia V, Rossi E, De Maio E, Piccirillo MC, D'Aiuto G, Thomas R, Rinaldo M, Botti G, Di Bonito M, Di Maio M, Gallo C, Perrone F, de Matteis A. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial. BMC Cancer. 2011 Feb 16;11:75. doi: 10.1186/1471-2407-11-75. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D015251 | Epirubicin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| epirubicin |
| Drug |
for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines |
|
| capecitabine | Drug | for metastatic breast cancer patients previously treated with anthracyclines |
|
| 2 years |
| Naples |
| 80131 |
| Italy |
| Ospedale S. Luca ASL SA 3 | Vallo della Lucania | Italy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |