Evaluating Efficacy and Tolerability of Anticancer Drug Therapies for the Treatment of Gynecologic and Breast Cancers

Recruiting

• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3); Breast Cancer Metastatic; Ovarian Cancer; Cervical Carcinoma; Endometrial Cancer
• Interventions: Drug: Oncologic drugs administered for treatment of breast cancer; Drug: Oncologic drug administered for treatment of gynecologic cancer

• Registration Number: NCT06800612
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2024-03-22
• Status Verified: 2024-12
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
retrospective cohort	Oncologic drugs administered for treatment of breast cancer	In this cohort data will be recorded retrospectively
retrospective cohort	Oncologic drug administered for treatment of gynecologic cancer	In this cohort data will be recorded retrospectively
prospective cohort	Oncologic drugs administered for treatment of breast cancer	In this cohort data will be recorded prospectively
prospective cohort	Oncologic drug administered for treatment of gynecologic cancer	In this cohort data will be recorded prospectively

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy