Metastatic Breast CancerPhase 2PARSIFALNCT02491983
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
A Phase 2 study testing Palbociclib, Fulvestrant and Letrozole in people with Metastatic Breast Cancer, run by MedSIR at 48 sites in 7 countries.
Trial summary
This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Palbociclib, Fulvestrant and Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 48 sitesin 7 countries
- Study dates
- Aug 2015to Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
- Confirmed diagnosis of HR+/HER2- breast cancer
- Post-menopausal status
- No prior chemotherapy line in the metastatic setting
- Measurable disease defined by RECIST version 1.1, or non-measurable disease
- Eastern Cooperative Oncology Group (ECOG) PS 0-1
- Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
- Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCICTCAE version 4.0 Grade equal or minor than 1
Who cannot join
- ER or HER2 unknown disease
- HER2 positive disease based on local laboratory results
- Locally advanced breast cancer candidate for a radical treatment
- Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of treatment.
- Patients with rapidly progressive visceral disease or visceral crisis.
- Major surgery within 4 weeks of start of study drug
Show all 14Show fewer
- Patients with an active, bleeding diathesis
- Serious concomitant systemic disorder incompatible with the study
- Are unable to swallow tablets
- Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day methylprednisolone equivalent
- Known active uncontrolled or symptomatic CNS metastases
- Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any PD-0332991 excipients
- QTc > 480 msec on basal assessments, personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
- Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug
Trial locations and contacts
48 sites in 7 countries.
48 sites in 7 countries
Spain18 sites
MedSIR investigative site
Barcelona, 08003
MedSIR investigative site
Barcelona, 08035
MedSIR investigative site
Barcelona, 08908
MedSIR investigative site
Bilbao, 48013
MedSIR investigative site
Cáceres, 10003
MedSIR investigative site
Castelló, 12002
MedSIR investigative site
Córdoba, 14004
MedSIR investigative site
Girona, 17007
MedSIR investigative site
Huelva, 21005
MedSIR investigative site
Madrid, 28046
MedSIR investigative site
Oviedo, 33011
MedSIR investigative site
Pamplona, 31008
MedSIR investigative site
Santiago de Compostela, 15706
MedSIR investigative site
Seville, 41013
MedSIR investigative site
Tarragona, 43005
MedSIR investigative site
Valencia, 46009
MedSIR investigative site B
Zaragoza, 50009
MedSIR investigative site
Zaragoza, 50009
Italy9 sites
MedSIR investigative site
Brindisi, 72021
MedSIR investigative site
Cagliari, 09134
MedSIR investigative site
Cremona, 26100
MedSIR investigative site
Milan, 20133
MedSIR investigative site
Milan, 20141
MedSIR investigative site
Modena, 41124
MedSIR investigative site
Monza, 20052
MedSIR investigative site
Piacenza
MedSIR investigative site
Torino, 10126
United Kingdom7 sites
MedSIR investigative site
Bath, BA1 3NG
MedSIR investigative site
London, EC1M 6BQ
MedSIR investigative site
Manchester, M20 4 BX
MedSIR investigative site
Nottingham, NG5 1PB
MedSIR investigative site
Romford, RM7 0AG
MedSIR investigative site
Swansea, SA2 8QA
MedSIR investigative site
Truro, TR1 3LQ
France5 sites
MedSIR investigative site
Paris, 75005
MedSIR investigative site
Paris, 75015
MedSIR investigative site
Paris, 75020
MedSIR investigative site
Strasbourg, 67065
MedSIR investigative site
Toulouse, 31059
Russia4 sites
MedSIR investigative site
Moscow, 115478
MedSIR investigative site
Moscow, 125284
MedSIR investigative site
Saint Petersburg, 197758
MedSIR investigative site
Yaroslavl, 150040
Czechia3 sites
MedSIR investigative site
Olomouc, 77600
MedSIR investigative site
Prague, 12000
MedSIR investigative site
Prague, 15006
Germany2 sites
MedSIR investigative site
Dessau, 06847
MedSIR investigative site
Heidelberg, 69120
About this study
Official title: A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer
This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.
Read the detailed description
Patients will be stratified by site of disease (visceral vs. non-visceral) and by onset of metastatic disease diagnose (patients metastatic de novo versus non de novo).
- Conditions
- Metastatic Breast Cancer
- Being tested
- Palbociclib, Fulvestrant, Letrozole
- Keywords
- metastatic breast cancer, Endocrine receptors positive, HER-2 negative
- 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 PD-0332991
FulvestrantDrug
Also called Faslodex
LetrozoleDrug
Also called Femara
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Combination of Palbociclib and Letrozole Receives: Drug: Palbociclib; Drug: Letrozole |
| Arm B | Experimental | Combination of Palbociclib and Fulvestrant Receives: Drug: Palbociclib; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Progression Free Survival
Percentage of patients who are alive and without evidence of tumor progression (defined using RECIST v1.1)
Measured: One year
Secondary outcomes (5)
Number of Participants With Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations •
Grade 3/4 adverse events, SAEs, deaths and discontinuations following the CTCAE v5 criteria
Measured: Through study completion. From baseline up to 51 months.
Time To Progression (TTP)
Time from randomization to disease progression
Measured: Through study completion. From baseline up to 51 months.
Overall Survival (OS)
Time from date of randomization to date of death due to any cause
Measured: Through study completion. From baseline up to 51 months.
Clinical Benefit Rate
Percentage of patients who experience a CR, PR or stable disease (for at least 24 weeks) and assessed by modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria.
Measured: Through study completion. From baseline up to 51 months.
Overall Response Rate
Proportion of patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)
Measured: Through study completion. From baseline up to 51 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Llombart, MD, Principal investigator, MedSIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491983
- Sponsor's protocol ID
- MedOPP067
- Other IDs
- 2014-004698-17, 2014
- Acronym
- PARSIFAL
- Status last verified
- Oct 2024
- First submitted
- 29 Jun 2015
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Di Cosimo S, Perez-Garcia JM, Bellet M, Dalenc F, Gil Gil MJ, Ruiz Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-De Duenas E, Caranana V, Amillano K, Mina L, Malfettone A, Cortes J, Llombart-Cussac A. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial. Oncologist. 2023 Jan 18;28(1):23-32. doi: 10.1093/oncolo/oyac205.
PubMed 36239405Llombart-Cussac A, Perez-Garcia JM, Bellet M, Dalenc F, Gil-Gil M, Ruiz-Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Di Cosimo S, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-de Duenas E, Amillano K, Malfettone A, Cortes J; PARSIFAL Steering Committee and Trial Investigators. Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor-Positive, ERBB2-Negative Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Dec 1;7(12):1791-1799. doi: 10.1001/jamaoncol.2021.4301.
PubMed 34617955
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02491983
- Acronym / sponsor ID
- PARSIFAL / MedOPP067
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic breast cancer, Endocrine receptors positive, HER-2 negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.
Detailed description
Patients will be stratified by site of disease (visceral vs. non-visceral) and by onset of metastatic disease diagnose (patients metastatic de novo versus non de novo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Palbociclib, Drug: LetrozoleCombination of Palbociclib and Letrozole |
| Arm B | Experimental | Drug: Palbociclib, Drug: FulvestrantCombination of Palbociclib and Fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
- Confirmed diagnosis of HR+/HER2- breast cancer
- Post-menopausal status
- No prior chemotherapy line in the metastatic setting
- Measurable disease defined by RECIST version 1.1, or non-measurable disease
Key exclusion criteria (14 listed)
- ER or HER2 unknown disease
- HER2 positive disease based on local laboratory results
- Locally advanced breast cancer candidate for a radical treatment
- Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of treatment.
- Patients with rapidly progressive visceral disease or visceral crisis.
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: PD-0332991 | Drug | Arm A, Arm B |
| FulvestrantAlso: Faslodex | Drug | Arm B |
| LetrozoleAlso: Femara | Drug | Arm A |
Primary outcome
1-year Progression Free Survival
Time frame: One year
Percentage of patients who are alive and without evidence of tumor progression (defined using RECIST v1.1)
5 secondary outcomes
Number of Participants With Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations •
Time frame: Through study completion. From baseline up to 51 months.
Time To Progression (TTP)
Time frame: Through study completion. From baseline up to 51 months.
Overall Survival (OS)
Time frame: Through study completion. From baseline up to 51 months.
Clinical Benefit Rate
Time frame: Through study completion. From baseline up to 51 months.
Overall Response Rate
Time frame: Through study completion. From baseline up to 51 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36239405Di Cosimo S, Perez-Garcia JM, Bellet M, Dalenc F, Gil Gil MJ, Ruiz Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-De Duenas E, Caranana V, Amillano K, Mina L, Malfettone A, Cortes J, Llombart-Cussac A. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial. Oncologist. 2023 Jan 18;28(1):23-32. doi: 10.1093/oncolo/oyac205.
- Derived from this study: PubMed 34617955Llombart-Cussac A, Perez-Garcia JM, Bellet M, Dalenc F, Gil-Gil M, Ruiz-Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Di Cosimo S, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-de Duenas E, Amillano K, Malfettone A, Cortes J; PARSIFAL Steering Committee and Trial Investigators. Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor-Positive, ERBB2-Negative Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Dec 1;7(12):1791-1799. doi: 10.1001/jamaoncol.2021.4301.
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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.
Antonio Llombart, MD principal investigator
MedSIR
48 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palbociclib, Fulvestrant and Letrozole in people with Metastatic Breast Cancer, run by MedSIR at 48 sites in 7 countries.
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 8 inclusion and 14 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Spain, Italy, United Kingdom, France, Russia and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
1-year Progression Free Survival (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02491983, which also lists 2 linked publications.
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 9 Dec 2024.