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

NCT ID: NCT06800612

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-22

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Cancer Metastatic Ovarian Cancer Cervical Carcinoma Endometrial Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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retrospective cohort

In this cohort data will be recorded retrospectively

Oncologic drugs administered for treatment of breast cancer

Intervention Type DRUG

Data on oncologic drugs administered for treatment of breast cancer will be recorded

Oncologic drug administered for treatment of gynecologic cancer

Intervention Type DRUG

Data on oncologic drugs administered for treatment of gynecologic cancer will be recorded

prospective cohort

In this cohort data will be recorded prospectively

Oncologic drugs administered for treatment of breast cancer

Intervention Type DRUG

Data on oncologic drugs administered for treatment of breast cancer will be recorded

Oncologic drug administered for treatment of gynecologic cancer

Intervention Type DRUG

Data on oncologic drugs administered for treatment of gynecologic cancer will be recorded

Interventions

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Oncologic drugs administered for treatment of breast cancer

Data on oncologic drugs administered for treatment of breast cancer will be recorded

Intervention Type DRUG

Oncologic drug administered for treatment of gynecologic cancer

Data on oncologic drugs administered for treatment of gynecologic cancer will be recorded

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudio Zamagni, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Claudio Zamagni, MD

Role: CONTACT

0512144548 ext. 0039

Cinzia Pizzirani, PhD

Role: CONTACT

0512144447 ext. 0039

Facility Contacts

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Claudio Zamagni, MD

Role: primary

0512144548 ext. 0039

Cinzia Pizzirani, PhD

Role: backup

2144447 ext. 0039

Other Identifiers

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STRATEGIA

Identifier Type: -

Identifier Source: org_study_id

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