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

ConditionsBreast Cancer Early Stage Breast Cancer (Stage 1-3)Breast Cancer MetastaticOvarian CancerCervical CarcinomaEndometrial Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

no exclusion criteria

Trial population

Patients treated for breast or gynecologic cancer from January 2010.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Oncologic drugs administered for treatment of breast cancer

    Drug

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

  • Oncologic drug administered for treatment of gynecologic cancer

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: retrospective cohort2 interventions
Group B: prospective cohort2 interventions

Trial outcomes

Primary outcomes

1

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

1

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.
2

OS

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.
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor

Source ClinicalTrials.gov
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