BreastNCT04524728
Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy
An observational study of Breast and Neoplasm Malignant, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary endpoint is the clinical benefit rate (CBR); secondary aims are the median PFS (mPFS), overall survival (OS) and safety. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast, Neoplasm Malignant, Female
- What is being tested?
- Palbociclib, Letrozole 2.5mg and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 191 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2016to Jun 2020
- How long will I take part?
- 100 Months
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: One hundred-ninety-one patients (92 in cohort A, 99 in cohort B) were enrolled and treated and 182 were evaluable for the analysis. Median age was 62 years (range 47-79)
Who may be able to join
- Pre- and postmenopausal women with a histologically proven HR+MBC, candidate to receive palbociclib plus ET as first or subsequent line of therapy according to their contingent clinical situation.
- HER2- disease (IHC 0-1 or IHC 2, confirmed as FISH negative), presence of measurable or evaluable lesions and life expectancy of at least 4 months.
- Adequate bone marrow, hepatic and renal function, according to clinical practice guidelines for antineoplastic drug administration
Who cannot join
- ER- PgR- disease
- HER2+ disease (IHC 3 or IHC 2, confirmed as FISH positive)
- Any cardiovascular, renal or hepatic condition that would compromise conditions in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy in Hormone Receptor-positive (HR+)/HER2 Receptor-negative (HER2-) Metastatic Breast Cancer (MBC): a Real World Multicentre Italian Study
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary endpoint is the clinical benefit rate (CBR); secondary aims are the median PFS (mPFS), overall survival (OS) and safety.
Read the detailed description
This is an open-label, longitudinal, prospective, multicentre cohort study. Eligible patients are pre- and postmenopausal women with a histologically proven HR+ MBC, candidate to receive palbociclib plus endocrine therapy (ET) as first or subsequent line of therapy according to their contingent clinical situation. Additional inclusion criteria are HER2- disease (immunohistochemistry (IHC) 0-1+ or IHC 2+, confirmed as fluorescence in situ hybridization [FISH] negative), presence of measurable or evaluable lesions and life expectancy of at least 4 months. They need to have adequate bone marrow, hepatic and renal function, according to clinical practice guidelines for antineoplastic drug administration. Previous chemotherapy or ET for metastatic disease is allowed. Patients receive palbociclib 125 mg daily, 3 weeks on/1 week off in a 28-day cycle, combined with letrozole 2.5 mg administered orally on a continuous daily dosing schedule (cohort A) or fulvestrant at the dose of 500 mg intramuscular on days 1, 14, 28, then every 4 weeks thereafter (cohort B). Premenopausal women receive a GnRH analogue in combination with ET and palbociclib. Treatment is administered until documented disease progression (PD), unacceptable toxicity or patient refusal. The tumour assessment is performed approximately every 16 weeks. Treatment efficacy is evaluated by Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). A complete blood count and organ function test is performed before each cycle, through study completion, an avarange of 1 year. No pre-specified treatment modifications are planned; dose reductions, delay or discontinuations of palbociclib are performed according to observed side effects. AEs are recorded and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0).
The primary aim of the study is to analyse the activity of palbociclib plus ET in terms of clinical benefit rate that is defined as the percentage of patients experiencing complete response (CR), partial response (PR), or stable disease (SD) lasting 6 months or more. Secondary aims include the evaluation of the safety of the treatments, progression-free survival and overall survival.
- Conditions
- Breast, Neoplasm Malignant, Female
- Being tested
- Palbociclib, Letrozole 2.5mg, Fulvestrant
- Keywords
- endocrine therapy, metastatic breast cancer, palbociclib, real world, visceral involvement
- Medical subject headings
- Neoplasms, 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
tablets
Letrozole 2.5mgDrug
Also called Femara
tablets
FulvestrantDrug
Also called Faslodex
intramuscolar injections
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients that received palbociclib combined with letrozole 2.5 mg Receives: Drug: Palbociclib; Drug: Letrozole 2.5mg | |
| Cohort B | Patients that received palbociclib combined with fulvestrant 500 mg Receives: Drug: Palbociclib; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate (CBR)
the percentage of patients experiencing complete response (CR), partial response (PR), or stable disease (SD) lasting 6 months or more
Measured: From the date of randomization through study completion, assessed up to 16 weeks
Secondary outcomes (3)
Median PFS
the time interval from the start of therapy with palbociclib plus ET to the date of
Measured: From date of randomization until the date of first documented progression, assessed up to 16 weeks through study completion
Overall survival
the interval from therapy start to the date of death or of last follow-up evaluation
Measured: from the date of randomization until the date of death from any cause or lost of follow-up, whichever came first, assessed up to 100 months.
Drug safety and tolerability
Incidence of Treatment-emergent adverse events (safety and tolerability) using CTCAE criteria
Measured: at day 1 of any cycle from the date of the start of therapy through study completion, an avarange of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study startDec 2016
- Primary completionApr 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe 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
- Prospective
- Enrolment
- 191 participants (actual)
- Target duration
- 100 Months
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raffaella Palumbo, MD, PhD, Principal investigator, ICS Maugeri, IRCCS, Department of Medical Oncology, Pavia, italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524728
- Sponsor's protocol ID
- CE 2295
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 24 Aug 2020
- 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 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy in Hormone Receptor-positive (HR+)/HER2 Receptor-negative (HER2-) Metastatic Breast Cancer (MBC): a Real World Multicentre Italian Study
- ClinicalTrials.gov ID
- NCT04524728
- Acronym / sponsor ID
- CE 2295
- Conditions
- Breast, Neoplasm Malignant, Female
- Keywords
- endocrine therapy, metastatic breast cancer, palbociclib, real world, visceral involvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 24 Aug 2020 (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.
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary endpoint is the clinical benefit rate (CBR); secondary aims are the median PFS (mPFS), overall survival (OS) and safety.
Detailed description
This is an open-label, longitudinal, prospective, multicentre cohort study. Eligible patients are pre- and postmenopausal women with a histologically proven HR+ MBC, candidate to receive palbociclib plus endocrine therapy (ET) as first or subsequent line of therapy according to their contingent clinical situation. Additional inclusion criteria are HER2- disease (immunohistochemistry (IHC) 0-1+ or IHC 2+, confirmed as fluorescence in situ hybridization [FISH] negative), presence of measurable or evaluable lesions and life expectancy of at least 4 months. They need to have adequate bone marrow, hepatic and renal function, according to clinical practice guidelines for antineoplastic drug administration. Previous chemotherapy or ET for metastatic disease is allowed. Patients receive palbociclib 125 mg daily, 3 weeks on/1 week off in a 28-day cycle, combined with letrozole 2.5 mg administered orally on a continuous daily dosing schedule (cohort A) or fulvestrant at the dose of 500 mg intramuscular on days 1, 14, 28, then every 4 weeks thereafter (cohort B). Premenopausal women receive a GnRH analogue in combination with ET and palbociclib. Treatment is administered until documented disease progression (PD), unacceptable toxicity or patient refusal. The tumour assessment is performed approximately every 16 weeks. Treatment efficacy is evaluated by Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). A complete blood count and organ function test is performed before each cycle, through study completion, an avarange of 1 year. No pre-specified treatment modifications are planned; dose reductions, delay or discontinuations of palbociclib are performed according to observed side effects. AEs are recorded and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0).
The primary aim of the study is to analyse the activity of palbociclib plus ET in terms of clinical benefit rate that is defined as the percentage of patients experiencing complete response (CR), partial response (PR), or stable disease (SD) lasting 6 months or more. Secondary aims include the evaluation of the safety of the treatments, progression-free survival and overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: Palbociclib, Drug: Letrozole 2.5mgPatients that received palbociclib combined with letrozole 2.5 mg |
| Cohort B | – | Drug: Palbociclib, Drug: FulvestrantPatients that received palbociclib combined with fulvestrant 500 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred-ninety-one patients (92 in cohort A, 99 in cohort B) were enrolled and treated and 182 were evaluable for the analysis. Median age was 62 years (range 47-79)
Key inclusion criteria (3 listed)
- Pre- and postmenopausal women with a histologically proven HR+MBC, candidate to receive palbociclib plus ET as first or subsequent line of therapy according to their contingent clinical situation.
- HER2- disease (IHC 0-1 or IHC 2, confirmed as FISH negative), presence of measurable or evaluable lesions and life expectancy of at least 4 months.
- Adequate bone marrow, hepatic and renal function, according to clinical practice guidelines for antineoplastic drug administration
Key exclusion criteria (3 listed)
- ER- PgR- disease
- HER2+ disease (IHC 3 or IHC 2, confirmed as FISH positive)
- Any cardiovascular, renal or hepatic condition that would compromise conditions in the opinion of the investigator
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: ibrancetablets | Drug | Cohort A, Cohort B |
| Letrozole 2.5mgAlso: Femaratablets | Drug | Cohort A |
| FulvestrantAlso: Faslodexintramuscolar injections | Drug | Cohort B |
Primary outcome
Clinical Benefit Rate (CBR)
Time frame: From the date of randomization through study completion, assessed up to 16 weeks
the percentage of patients experiencing complete response (CR), partial response (PR), or stable disease (SD) lasting 6 months or more
3 secondary outcomes
Median PFS
Time frame: From date of randomization until the date of first documented progression, assessed up to 16 weeks through study completion
Overall survival
Time frame: from the date of randomization until the date of death from any cause or lost of follow-up, whichever came first, assessed up to 100 months.
Drug safety and tolerability
Time frame: at day 1 of any cycle from the date of the start of therapy through study completion, an avarange of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
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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.
Raffaella Palumbo, MD, PhD principal investigator
ICS Maugeri, IRCCS, Department of Medical Oncology, Pavia, italy
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 and Neoplasm Malignant, run by Istituti Clinici Scientifici Maugeri SpA 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 3 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: finished, as of the sponsor's last update on 24 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate (CBR) (time frame: From the date of randomization through study completion, assessed up to 16 weeks). 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 24 Aug 2020.