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retrospective/prospective observational study. Objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.
This is a single-center retrospective/prospective observational study. Objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.
Regarding the prospective component of the study, it is clarified that therapy will be warranted by clinical practice regardless of study enrollment. Diagnostic investigations will also be conducted as per normal practice; enrollment in the study does not require additional examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| retrospective cohort | In this cohort data will be recorded retrospectively |
| |
| prospective cohort | In this cohort data will be recorded prospectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncologic drugs administered for treatment of breast cancer | Drug | Data on oncologic drugs administered for treatment of breast cancer will be recorded |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS | To evaluate effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: disease-free survival (DFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: progression-free survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated for breast or gynecologic cancer from January 2010.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudio Zamagni, MD | Contact | 0512144548 | 0039 | zamagniclaudio.sper@aosp.bo.it |
| Cinzia Pizzirani, PhD | Contact | 0512144447 | 0039 | cinzia.pizzirani@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Zamagni, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
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| Oncologic drug administered for treatment of gynecologic cancer | Drug | Data on oncologic drugs administered for treatment of gynecologic cancer will be recorded |
|
| OS |
Effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: overall survival (OS) |
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. |
| Side effects | Effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: side effects | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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