Breast Cancer Stage IVPhase 3NCT05670054
Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast Cancer Patients
A Phase 3 study testing comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival in people with Breast Cancer Stage IV, run by Mansoura University at 1 site in Egypt.
Trial summary
Breast cancer is the commonest malignancy among females and one of the leading causes of death worldwide. Many drugs have been developed over the years to try to extend survival among these patients including cyclin dependant kinase inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Stage IV
- What is being tested?
- comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 15 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- - Pathologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease either progression on adjuvant hormonal or progression on 1st line hormonal for metastatic disease.
- Documentation of ER-positive and/or PR-positive and HER2 negative.
- Prior use of endocrine therapy.
- age >18 years old.
- ECOG: 0-2
- Postmenopausal is defined as: age>60 years old or < 60 years old with cessation off menstruation for at least 12 months and FSH or E2 in postmenopausal range or patients who underwent bilateral oophorectomy.
- Premenopausal is defined if not meeting the criteria of postmenopausal. They are obligated to receive LHRH agonist with their treatment.
Who cannot join
- - Age < 18 years old
- Patients with advanced/metastatic, symptomatic, visceral spread(visceral crisis) , that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
- 2nd malignancy other than breast cancer
- ECOG more than 3
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Oncology center mansoura university
Al Mansurah, Dakahlia Governorate, 35516
manar hamed, MD, 01063678209, manarhamed@mans.edu.eg
ahmed tantawy, MD, 01091203484, hamedmanar9@gmail.com
About this study
Breast cancer is the commonest malignancy among females and one of the leading causes of death worldwide. Many drugs have been developed over the years to try to extend survival among these patients including cyclin dependant kinase inhibitors. Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive, HER2 negative advanced breast cancer in the 1st line and subsequent lines in combination with aromatase inhibitors or fulvestrant. Studies showed that they extend progression free survival and recently they showed overall survival benefit. In this study investigators compare Palbociclib+ fulvestrant VS Ribociclib + fulvestrant as a second line treatment in metastatic ER+ve her2 -ve BC in oncology center mansoura university egyptian patients.
Read the detailed description
Breast cancer is the commonest malignancy among females and one of the leading causes of death worldwide. Many drugs have been developed over the years to try to extend survival among these patients including cyclin dependant kinase inhibitors. Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive, HER2 negative advanced breast cancer in the 1st line and subsequent lines in combination with aromatase inhibitors or fulvestrant. Studies showed that they extend progression free survival and recently they showed overall survival benefit. In this study investigators compare Palbociclib+ fulvestrant VS Ribociclib + fulvestrant as a second line treatment in metastatic ER+ve her2 -ve BC in oncology center mansoura university egyptian patients. The efficacy and comparative toxicity of CDK inhibitors were indirectly compared in a number of trials. Despite differences in inclusion criteria and follow-up length, second-line trials showed similar characteristics.
Unfortunately, despite the similar efficacy and overall response rate (ORR) and a slightly different but near-identical spectrum of adverse events, both agents have not been directly compared with each other. This study aims to fill that gap, and evaluate the toxicity, tolerability and response rate of ribociclib plus fulvestrant versus palbociclib plus fulvestrant, to inform the decision makers.
- Conditions
- Breast Cancer Stage IV
- Being tested
- comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survivalDrug
comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival
| Study group | Role | What they receive |
|---|---|---|
| palbociclib + fulvestrant | Active comparator | Arm A includes patients who receive palbociclib 125 mg tab/day for 3 weeks and 1 week rest+ Fulvestrant 500 mg IM injection d1, d15, d29 1st cycle then every month Receives: Drug: comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival |
| Ribociclib + fulvestrant | Active comparator | Arm B includes patients who receive ribociclib 200 mg 3 tabs/day for 3 weeks and 1 week rest+ Fulvestrant 500 mg IM injection d1, d15, d29 1st cycle then every month Receives: Drug: comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of objective response and clinical benefit
compare objective response rate and clinical benefit rate between the 2 arms
Measured: the last patient recruited in the study will be followed up for at least 6 months
Incidence and grade of toxicity
compare the incidence and grade of toxicity between the 2 arms
Measured: the last patient recruited in the study will be followed up for at least 6 months
Compare Quality of life score of the patients using EORTC core quality of life questionaire version C-30
compare the level of deterioration of the quality of life score between the 2 arms
Measured: each patient will answer the QOL score at D0, 3rd and 6 months of treatment as long as he is hasn't progressed on treatment during the 1st 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Mar 2022
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Hamed, Mansoura University
- Investigators
- manar hamed, MD, Principal investigator, Oncology center mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670054
- Sponsor's protocol ID
- MD.22.07.674
- Status last verified
- Jan 2023
- First submitted
- 17 Dec 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the results of the study will be shared and published
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05670054
- Acronym / sponsor ID
- MD.22.07.674
- Conditions
- Breast Cancer Stage IV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 4 Jan 2023 (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.
Breast cancer is the commonest malignancy among females and one of the leading causes of death worldwide. Many drugs have been developed over the years to try to extend survival among these patients including cyclin dependant kinase inhibitors. Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive, HER2 negative advanced breast cancer in the 1st line and subsequent lines in combination with aromatase inhibitors or fulvestrant. Studies showed that they extend progression free survival and recently they showed overall survival benefit. In this study investigators compare Palbociclib+ fulvestrant VS Ribociclib + fulvestrant as a second line treatment in metastatic ER+ve her2 -ve BC in oncology center mansoura university egyptian patients.
Detailed description
Breast cancer is the commonest malignancy among females and one of the leading causes of death worldwide. Many drugs have been developed over the years to try to extend survival among these patients including cyclin dependant kinase inhibitors. Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive, HER2 negative advanced breast cancer in the 1st line and subsequent lines in combination with aromatase inhibitors or fulvestrant. Studies showed that they extend progression free survival and recently they showed overall survival benefit. In this study investigators compare Palbociclib+ fulvestrant VS Ribociclib + fulvestrant as a second line treatment in metastatic ER+ve her2 -ve BC in oncology center mansoura university egyptian patients. The efficacy and comparative toxicity of CDK inhibitors were indirectly compared in a number of trials. Despite differences in inclusion criteria and follow-up length, second-line trials showed similar characteristics.
Unfortunately, despite the similar efficacy and overall response rate (ORR) and a slightly different but near-identical spectrum of adverse events, both agents have not been directly compared with each other. This study aims to fill that gap, and evaluate the toxicity, tolerability and response rate of ribociclib plus fulvestrant versus palbociclib plus fulvestrant, to inform the decision makers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| palbociclib + fulvestrant | Active comparator | Drug: comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survivalArm A includes patients who receive palbociclib 125 mg tab/day for 3 weeks and 1 week rest+ Fulvestrant 500 mg IM injection d1, d15, d29 1st cycle then every month |
| Ribociclib + fulvestrant | Active comparator | Drug: comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survivalArm B includes patients who receive ribociclib 200 mg 3 tabs/day for 3 weeks and 1 week rest+ Fulvestrant 500 mg IM injection d1, d15, d29 1st cycle then every month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - Pathologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease either progression on adjuvant hormonal or progression on 1st line hormonal for metastatic disease.
- Documentation of ER-positive and/or PR-positive and HER2 negative.
- Prior use of endocrine therapy.
- age >18 years old.
- ECOG: 0-2
Key exclusion criteria (4 listed)
- - Age < 18 years old
- Patients with advanced/metastatic, symptomatic, visceral spread(visceral crisis) , that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
- 2nd malignancy other than breast cancer
- ECOG more than 3
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 |
|---|---|---|
| comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survivalcomparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival | Drug | Ribociclib + fulvestrant, palbociclib + fulvestrant |
Primary outcome
The rate of objective response and clinical benefit
Time frame: the last patient recruited in the study will be followed up for at least 6 months
compare objective response rate and clinical benefit rate between the 2 arms
Incidence and grade of toxicity
Time frame: the last patient recruited in the study will be followed up for at least 6 months
compare the incidence and grade of toxicity between the 2 arms
Compare Quality of life score of the patients using EORTC core quality of life questionaire version C-30
Time frame: each patient will answer the QOL score at D0, 3rd and 6 months of treatment as long as he is hasn't progressed on treatment during the 1st 6 months
compare the level of deterioration of the quality of life score between the 2 arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: Yes. the results of the study will be shared and published
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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. This study is not recruiting at the moment.
manar hamed, MD principal investigator
Oncology center mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival in people with Breast Cancer Stage IV, run by Mansoura University at 1 site in Egypt.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Jan 2023. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact manar hamed, MD (+201063678209, manarhamed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of objective response and clinical benefit (time frame: the last patient recruited in the study will be followed up for at least 6 months). The study lists 3 primary outcomes in all. 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 4 Jan 2023.