Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic, Cervical Carcinoma, Endometrial Cancer, Ovarian Cancer
Conditions
Keywords
observational, breast cancer, gynecologic cancer, ovarian cancer, cervical carcinoma, endometrial cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGOncologic drugs administered for treatment of breast cancer
Data on oncologic drugs administered for treatment of breast cancer will be recorded
DRUGOncologic drug administered for treatment of gynecologic cancer
Data on oncologic drugs administered for treatment of gynecologic cancer will be recorded
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of histologically confirmed breast cancer or gynecological cancer, either early stage or metastatic; * Patients who have received treatment for breast cancer or gynecologic cancer since January 2010; * Any patient currently living and actually contactable must sign an informed consent to the study and processing of personal data.
Exclusion criteria
* no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: progression-free survival (PFS) |
| 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. | Effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: overall survival (OS) |
| 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. | Effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: side effects |
Countries
Italy
Contacts
Primary ContactClaudio Zamagni, MD
Backup ContactCinzia Pizzirani, PhD
Outcome results
None listed