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

IRCCS Azienda Ospedaliero-Universitaria di Bologna100 enrolled

Overview

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.

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

100

Conditions

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

Interventions

Oncologic drugs administered for treatment of breast cancerDRUG

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

Oncologic drug administered for treatment of gynecologic cancerDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

DFS

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)

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.

Secondary Outcomes

PFS

Effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: progression-free survival (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: overall survival (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.

Side effects

Effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: 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.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts