Metastatic Breast CancerPALBONCT05135104
Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period
An observational study of Metastatic Breast Cancer, run by Asociatia Oncohelp - Centrul de Oncologie Oncohelp at 7 sites in Romania.
Trial summary
PALBO is a Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During A 2.5 Years Follow-Up Period. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Palbociclib
- Type of treatment
- Pill or oral medicine
- How many people
- 650 participants
- Where
- 7 sitesRomania
- Study dates
- 15 Dec 2021to 25 May 2024
- Phase
- Observational
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of subjects aged 18 years and older with a confirmed diagnosis of Estrogen Receptor Positive, HER2 Negative MBC. Eligible subjects must have undergone a treatment with Palbociclib for at least 3 months.
Who may be able to join
- Adult women and men (≥ 18 years of age) with proven initial diagnosis of breast cancer with evidence of loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy.
- Documentation of histologically or cytologically confirmed diagnosis of breast cancer with IHC of estrogen receptor (ER) expression > 1% and/or progesterone receptor (PR) expression >1 % breast cancer based on local laboratory results.
- Scoring of 0 or 1+ for HER2 protein expression by a validated immunohistochemistry assay or +1/+2 with negative HER2 amplification FISH/ISH ratio lower than 1.8 or HER2 gene copy less than 4.0.
- Eligible subjects must have undergone a treatment with Palbociclib for at least 3 months.
- Measurable or evaluable disease as defined per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion (at least 2 entries).
- Premenopausal or postmenopausal status.
Show all 11Show fewer
- 6.1 Patients who are not postmenopausal must have undergone a treatment with LHRH agonist.
- 6.2 Postmenopausal status is defined as:
- prior bilateral surgical oophorectomy, or
- spontaneous cessation of regular menses for at least 12 consecutive months
- in case of doubt serum estradiol <20 umol/l and follicle stimulating hormone (FSH) levels >15 IU/L.
Who cannot join
- Subjects with advanced, symptomatic, visceral spread, such as patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement).
- Palbociclib treatment as part of a clinical trial or prescription prior to market approval (Nov 2016).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Romania7 sites, 7 recruiting
- Recruiting
Spitalul Clinic de Obstetrică Și Ginecologie Filantropia
Bucharest, 011171
Mircea Dragoș Median, PI
- Recruiting
Institutul Oncologic "Prof. Dr I. Chiricuta"
Cluj-Napoca, 400015
Nicoleta Zenovia Antone, PI
- Recruiting
Spitalul Clinic Județean de Urgență Cluj-Napoca
Cluj-Napoca, 400349
Dorina Larisa Ciule, PI
- Recruiting
Centrul de Oncologie "Sf. Nectarie"
Craiova, 200746
Michael Schenker, PI
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Bogdan Gafton, PI
- Recruiting
Spitalul Clinic Județean de Urgență Oradea
Oradea, 410469
Aniela Platona, PI
- Recruiting
Asociatia Oncohelp - Centrul de Oncologie Oncohelp
Timișoara, Timiș County, 300239
Cristina M Oprean, PI, coprean@yahoo.com
About this study
Official title: Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period
PALBO is a Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During A 2.5 Years Follow-Up Period. The primary objective is to identify pathological and clinical features of MBC that is associated with Palbociclib's best efficacy, measured by response rate (overall response rate, duration of response and best clinical response), progression free survival and OS. Safety of Palbociclib will also be evaluated.
Read the detailed description
Metastatic breast cancer (MBC) is the most advanced stage of breast cancer, where the disease has spread to distant sites beyond the axillary lymph nodes. At European level, MBC occurs in up to 20-30 percent of women diagnosed with early-stage breast cancer. At regional level, there are variations in newly diagnosed patients who present with metastatic disease. In high income countries fewer than 8% of patients are initially diagnosed with MBC, while the highest burden of MBC is carried by low and middle-income countries where up to 60% are initially diagnosed with MBC. Currently, the median overall survival for patients with MBC is approximately 2 to 3 years in developed countries, but lower in developing countries. In Romania, 8900 new cases of BC are diagnosed every year, with 80% being diagnosed in an advance stage of the disease (II, III, IV). Furthermore, after initial BC treatment, approximately 50% will develop MBC.
Cyclin-dependent kinase (CDK) 4/6 inhibitors (Palbociclib, ribociclib and abemaciclib) are now standard of care for the treatment of advanced hormone receptor positive (HR+) and HER2 negative (HER2-) breast cancer.
On 09 November 2016, the EC has approved IBRANCE® (Palbociclib) as the first CDK 4/6 inhibitor, to be used in combination with letrozol as first-line or in combination with fulvestrant in women who have received prior endocrine therapy, based on the results of PALOMA-1, PALOMA-2 and PALOMA-3 study results. Other phase III randomized trials have been reported and confirmed the efficacy of CDK4/6 inhibition in both first-line and endocrine resistant settings.
Palbociclib®, an orally active pyridopyrimidine, is a potent and highly selective reversible inhibitor of CDK 4 and CDK6. The compound prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 into the S phase. Specifically, Palbociclib inhibits CDK4/6-catalyzed phosphorylation of the retinoblastoma protein (Rb), which is required for cell division.
Palbociclib® has selectivity for CDK4/6, with little or no activity against a large panel of 274 other protein kinases including other CDKs and a wide variety of tyrosine and serine/threonine kinases.
An approximate number of 650 patients will be included in the present study which will take place on national level in 6 sites in Romania.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Palbociclib
- Keywords
- Breast Cancer, Metastatic Breast Cancer, Her2 Negative Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance
Palbociclib, an orally active pyridopyrimidine, is a potent and highly selective reversible inhibitor of CDK 4 and CDK6. The compound prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 into the S phase. Specifically, Palbociclib inhibits CDK4/6-catalyzed phosphorylation of the retinoblastoma protein (Rb), which is required for cell division.
Palbociclib has selectivity for CDK4/6, with little or no activity against a large panel of 274 other protein kinases including other CDKs and a wide variety of tyrosine and serine/threonine kinases.
Therapeutic indications:
Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or MBC:
- in combination with an aromatase inhibitor;
- in combination with fulvestrant in women who have received prior endocrine therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR) in subjects participating in the clinical investigation [ Time Frame: 2.5 years]
DCR will be calculated per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion, as the proportion of patients with best overall response to protocol therapy of complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 12 weeks.
Measured: 2.5 years
Overall Survival (OS) investigation [ Time Frame: 2.5 years]
OS will be defined as the elapsed time from the enrolment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will at 1, 2 and 3 months until death or withdrawal of consent from the study.
Measured: 2.5 years
Objective Response Rate (ORR) investigation [ Time Frame: 2.5 years]
ORR will be defined as the proportion of the patients with a confirmed CR or PR, as per mRECIST V1.1 criterion.
Measured: 2.5 years
Duration of Response (DOR) investigation [ Time Frame: 2.5 years]
DOR will be defined as the elapsed time from documented tumour response to documented disease progression.
Measured: 2.5 years
Secondary outcomes (6)
The medium duration of the treatment with Palbociclib in combination with aromatase inhibitors (AI) in first-line and with fulvestrant in second-line
The first secondary objective of our study is to identify the medium duration of the treatment with aromatase inhibitors (AI) in first-line and with fulvestrant in second-line.
Measured: 2.5 years
The Clinical Benefit Rate (CBR), defined as the proportion of patients with no disease progression after 6 months of therapy.
The second secondary objective of our study is to identify the Clinical Benefit Rate (CBR), defined as the proportion of patients with no disease progression after 6 months of therapy.
Measured: 6 months after therapy start
PFS in a selected subgroup with KI67 mutation
Exploratory variable
Measured: 2.5 years
PFS in a selected subgroup of subjects with lower levels of HER2 expression (HER2-low) defined as HER2 immunohistochemistry 1+ or 2+, but FISH negative
Exploratory variable
Measured: 2.5 years
PFS in lobular/ductal/other histological subtypes
Exploratory variable
Measured: 2.5 years
PFS in a selected subgroup with Luminal B subtype
Exploratory variable
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start15 Dec 2021
- Primary completion25 Mar 2024 (estimated)
- Study completion25 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociatia Oncohelp - Centrul de Oncologie Oncohelp
- Sponsor type
- University, hospital or other
- Collaborators
- MDX Research
- Responsible party
- Sponsor
- Investigators
- Cristina Marinela Oprean, MD, Principal investigator, ASOCIATIA ONCOHELP - CENTRUL DE ONCOLOGIE ONCOHELP, DEPARTMENT OF MEDICAL ONCOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135104
- Sponsor's protocol ID
- PALBO01/2021
- Acronym
- PALBO
- Status last verified
- Dec 2022
- First submitted
- 1 Nov 2021
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period
- ClinicalTrials.gov ID
- NCT05135104
- Acronym / sponsor ID
- PALBO / PALBO01/2021
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer, Metastatic Breast Cancer, Her2 Negative Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Asociatia Oncohelp - Centrul de Oncologie OncohelpUniversity, hospital or other
- Collaborators
- MDX Research
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 25 Mar 2024 (estimated)
- Study completion
- 25 May 2024 (estimated)
- First posted
- 26 Nov 2021 (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.
PALBO is a Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During A 2.5 Years Follow-Up Period. The primary objective is to identify pathological and clinical features of MBC that is associated with Palbociclib's best efficacy, measured by response rate (overall response rate, duration of response and best clinical response), progression free survival and OS. Safety of Palbociclib will also be evaluated.
Detailed description
Metastatic breast cancer (MBC) is the most advanced stage of breast cancer, where the disease has spread to distant sites beyond the axillary lymph nodes. At European level, MBC occurs in up to 20-30 percent of women diagnosed with early-stage breast cancer. At regional level, there are variations in newly diagnosed patients who present with metastatic disease. In high income countries fewer than 8% of patients are initially diagnosed with MBC, while the highest burden of MBC is carried by low and middle-income countries where up to 60% are initially diagnosed with MBC. Currently, the median overall survival for patients with MBC is approximately 2 to 3 years in developed countries, but lower in developing countries. In Romania, 8900 new cases of BC are diagnosed every year, with 80% being diagnosed in an advance stage of the disease (II, III, IV). Furthermore, after initial BC treatment, approximately 50% will develop MBC.
Cyclin-dependent kinase (CDK) 4/6 inhibitors (Palbociclib, ribociclib and abemaciclib) are now standard of care for the treatment of advanced hormone receptor positive (HR+) and HER2 negative (HER2-) breast cancer.
On 09 November 2016, the EC has approved IBRANCE® (Palbociclib) as the first CDK 4/6 inhibitor, to be used in combination with letrozol as first-line or in combination with fulvestrant in women who have received prior endocrine therapy, based on the results of PALOMA-1, PALOMA-2 and PALOMA-3 study results. Other phase III randomized trials have been reported and confirmed the efficacy of CDK4/6 inhibition in both first-line and endocrine resistant settings.
Palbociclib®, an orally active pyridopyrimidine, is a potent and highly selective reversible inhibitor of CDK 4 and CDK6. The compound prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 into the S phase. Specifically, Palbociclib inhibits CDK4/6-catalyzed phosphorylation of the retinoblastoma protein (Rb), which is required for cell division.
Palbociclib® has selectivity for CDK4/6, with little or no activity against a large panel of 274 other protein kinases including other CDKs and a wide variety of tyrosine and serine/threonine kinases.
An approximate number of 650 patients will be included in the present study which will take place on national level in 6 sites in Romania.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of subjects aged 18 years and older with a confirmed diagnosis of Estrogen Receptor Positive, HER2 Negative MBC. Eligible subjects must have undergone a treatment with Palbociclib for at least 3 months.
Key inclusion criteria (11 listed)
- Adult women and men (≥ 18 years of age) with proven initial diagnosis of breast cancer with evidence of loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy.
- Documentation of histologically or cytologically confirmed diagnosis of breast cancer with IHC of estrogen receptor (ER) expression > 1% and/or progesterone receptor (PR) expression >1 % breast cancer based on local laboratory results.
- Scoring of 0 or 1+ for HER2 protein expression by a validated immunohistochemistry assay or +1/+2 with negative HER2 amplification FISH/ISH ratio lower than 1.8 or HER2 gene copy less than 4.0.
- Eligible subjects must have undergone a treatment with Palbociclib for at least 3 months.
- Measurable or evaluable disease as defined per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion (at least 2 entries).
Key exclusion criteria (2 listed)
- Subjects with advanced, symptomatic, visceral spread, such as patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement).
- Palbociclib treatment as part of a clinical trial or prescription prior to market approval (Nov 2016).
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 |
|---|---|---|
| PalbociclibAlso: IbrancePalbociclib, an orally active pyridopyrimidine, is a potent and highly selective reversible inhibitor of CDK 4 and CDK6. The compound prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 into the S phase. Specifically, Palbociclib inhibits CDK4/6-catalyzed phosphorylation of the retinoblastoma protein (Rb), which is required for cell division. Palbociclib has selectivity for CDK4/6, with little or no activity against a large panel of 274 other protein kinases including other CDKs and a wide variety of tyrosine and serine/threonine kinases. Therapeutic indications: Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or MBC: * in combination with an aromatase inhibitor; * in combination with fulvestrant in women who have received prior endocrine therapy. | Drug | – |
Primary outcome
Disease Control Rate (DCR) in subjects participating in the clinical investigation [ Time Frame: 2.5 years]
Time frame: 2.5 years
DCR will be calculated per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion, as the proportion of patients with best overall response to protocol therapy of complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 12 weeks.
Overall Survival (OS) investigation [ Time Frame: 2.5 years]
Time frame: 2.5 years
OS will be defined as the elapsed time from the enrolment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will at 1, 2 and 3 months until death or withdrawal of consent from the study.
Objective Response Rate (ORR) investigation [ Time Frame: 2.5 years]
Time frame: 2.5 years
ORR will be defined as the proportion of the patients with a confirmed CR or PR, as per mRECIST V1.1 criterion.
Duration of Response (DOR) investigation [ Time Frame: 2.5 years]
Time frame: 2.5 years
DOR will be defined as the elapsed time from documented tumour response to documented disease progression.
6 secondary outcomes
The medium duration of the treatment with Palbociclib in combination with aromatase inhibitors (AI) in first-line and with fulvestrant in second-line
Time frame: 2.5 years
The Clinical Benefit Rate (CBR), defined as the proportion of patients with no disease progression after 6 months of therapy.
Time frame: 6 months after therapy start
PFS in a selected subgroup with KI67 mutation
Time frame: 2.5 years
PFS in a selected subgroup of subjects with lower levels of HER2 expression (HER2-low) defined as HER2 immunohistochemistry 1+ or 2+, but FISH negative
Time frame: 2.5 years
PFS in lobular/ductal/other histological subtypes
Time frame: 2.5 years
PFS in a selected subgroup with Luminal B subtype
Time frame: 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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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.
Cristina Marinela Oprean, MD principal investigator
ASOCIATIA ONCOHELP - CENTRUL DE ONCOLOGIE ONCOHELP, DEPARTMENT OF MEDICAL ONCOLOGY
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Asociatia Oncohelp - Centrul de Oncologie Oncohelp at 7 sites in Romania.
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 11 inclusion and 2 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Oprean, PI (+40 721 893 630, coprean@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (DCR) in subjects participating in the clinical investigation [ Time Frame: 2.5 years] (time frame: 2.5 years). The study lists 4 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 17 May 2023.