Actively Recruiting

Age: 18Years +
All Genders
ID06800612

Observational Study Evaluating the Efficacy and Tolerability of Anticancer Drug Therapies for Breast and Gynecologic Cancers Compared with Registration Studies

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-30

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research is an observational study that looks at how anticancer drug therapies work and how tolerable they are for patients with breast and gynecologic cancers. The study aims to compare real-world results of these treatments with those reported in previous registration studies, focusing on outcomes like response to treatment, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects. It includes both past data and ongoing patient follow-up to gain a comprehensive understanding of these cancer treatments. The study has two parts: one that reviews patient data collected in the past and another that follows patients prospectively while they receive treatment as part of regular medical care. No additional tests are required for enrollment beyond standard clinical practice. Data on the anticancer drugs administered for breast and gynecologic cancers will be recorded and analyzed to assess treatment outcomes and side effects over time. Participants will be observed through their routine clinical visits without extra procedures caused by the study. Researchers will track and measure key outcomes such as disease progression, survival rates, and side effects for up to 60 months. The study does not require any extra diagnostic tests beyond normal care and focuses on gathering information to better understand the effectiveness and tolerability of these cancer treatments in everyday clinical settings.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Patients currently living and able to provide informed consent for the study and personal data processing
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 60 months

Participants who undergo routine care are observed to evaluate the effect of anticancer drugs on disease outcomes and side effects.

Visits as per routine clinical practice

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

C

Claudio Zamagni, MD

C

Cinzia Pizzirani, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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