Evaluating Efficacy and Tolerability of Anticancer Drug Therapies for the Treatment of Gynecologic and Breast Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oncologic drugs administered for treatment of breast cancer, Oncologic drug administered for treatment of gynecologic cancer.
- Who it may be relevant to
- Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic, Ovarian Cancer, Cervical Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Study Evaluating the Efficacy and Tolerability of Anticancer Drug Therapies Adopted for the Treatment of Gynecologic and Breast Cancers in Clinical Practice Compared with the Results of Registration Studies
Overview
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
- Drug Oncologic drugs administered for treatment of breast cancer
Data on oncologic drugs administered for treatment of breast cancer will be recorded - Drug Oncologic drug administered for treatment of gynecologic cancer
Data on oncologic drugs administered for treatment of gynecologic cancer will be recorded
Primary outcome measures
- DFS [Time frame: 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.]
Secondary outcome measures (3)
- PFS [Time frame: 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.]
- OS [Time frame: 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 [Time frame: 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.]
Eligibility criteria
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 exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06800612 · STRATEGIA