Clinical trial NCT06800612: Evaluating Efficacy and Tolerability of Anticancer Drug Therapies for the Treatment of Gynecologic and Breast Cancers
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Breast Cancer Metastatic
Ovarian Cancer
Cervical Carcinoma
Endometrial Cancer
Keywords: observational
breast cancer
gynecologic cancer
ovarian cancer
cervical carcinoma
endometrial cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for breast or gynecologic cancer from January 2010.

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.

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

Primary outcomes:
measure: DFS
timeFrame: 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 outcomes:
measure: PFS
timeFrame: 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: OS
timeFrame: 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: Side effects
timeFrame: 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.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
name: Claudio Zamagni, MD
role: PRINCIPAL_INVESTIGATOR
References: