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

January 28, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated for breast or gynecologic cancer from January 2010.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
retrospective cohort
In this cohort data will be recorded retrospectively
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
prospective cohort
In this cohort data will be recorded prospectively
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Claudio Zamagni, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRATEGIA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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