Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT06800612
Evaluating Efficacy and Tolerability of Anticancer Drug Therapies for the Treatment of Gynecologic and Breast Cancers
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Cancer Metastatic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic, Ovarian Cancer
- What is being tested?
- Oncologic drugs administered for treatment of breast cancer and Oncologic drug administered for treatment of gynecologic cancer
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2024to 31 Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for breast or gynecologic cancer from January 2010.
Who may be able to join
- 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.
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Claudio Zamagni, MD, 0512144548 ext. 0039, zamagniclaudio.sper@aosp.bo.it
Cinzia Pizzirani, PhD, 2144447 ext. 0039, cinzia.pizzirani@aosp.bo.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic, Ovarian Cancer, Cervical Carcinoma, Endometrial Cancer
- Being tested
- Oncologic drugs administered for treatment of breast cancer, Oncologic drug administered for treatment of gynecologic cancer
- Keywords
- observational, breast cancer, gynecologic cancer, ovarian cancer, cervical carcinoma, endometrial cancer
- Medical subject headings
- Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| retrospective cohort | In this cohort data will be recorded retrospectively Receives: Drug: Oncologic drugs administered for treatment of breast cancer; Drug: Oncologic drug administered for treatment of gynecologic cancer | |
| prospective cohort | In this cohort data will be recorded prospectively Receives: Drug: Oncologic drugs administered for treatment of breast cancer; Drug: Oncologic drug administered for treatment of gynecologic cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (3)
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)
Measured: 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
Effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: overall survival (OS)
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start22 Mar 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Zamagni, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800612
- Sponsor's protocol ID
- STRATEGIA
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06800612
- Acronym / sponsor ID
- STRATEGIA
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic, Ovarian Cancer, Cervical Carcinoma, Endometrial Cancer
- Keywords
- observational, breast cancer, gynecologic cancer, ovarian cancer, cervical carcinoma, endometrial cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective cohort | – | Drug: Oncologic drugs administered for treatment of breast cancer, Drug: Oncologic drug administered for treatment of gynecologic cancerIn this cohort data will be recorded retrospectively |
| prospective cohort | – | Drug: Oncologic drugs administered for treatment of breast cancer, Drug: Oncologic drug administered for treatment of gynecologic cancerIn this cohort data will be recorded prospectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for breast or gynecologic cancer from January 2010.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncologic drugs administered for treatment of breast cancerData on oncologic drugs administered for treatment of breast cancer will be recorded | Drug | prospective cohort, retrospective cohort |
| Oncologic drug administered for treatment of gynecologic cancerData on oncologic drugs administered for treatment of gynecologic cancer will be recorded | Drug | prospective cohort, retrospective cohort |
Primary outcome
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)
3 secondary outcomes
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudio Zamagni, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Cancer Metastatic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Zamagni, MD (0512144548 ext. 0039, zamagniclaudio.sper@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.