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Metastatic Breast CancerNCT06525675

Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)

An observational study of Metastatic Breast Cancer and Advanced Breast Cancer, run by MedSIR at 36 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this study is to evaluate the extended Overall Survival (OS) from PARSIFAL trial - NCT02491983 focused on the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with Human Epidermal growth factor Receptor 2 (HER2)-negative, Endocrine Receptor (ER)-positive… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Fulvestrant Injectable Product, Letrozole 2.5mg and Palbociclib 125mg
How many people
419 participants
Where
36 sitesin 6 countries
Study dates
18 Jul 2022to 2 Sep 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Eligible women were aged 18 y or older with menopausal status and HER2-negative/ER-positive, unresectable, locally advanced, or metastatic breast cancer not treatable with curative intent. Patients had not received systemic therapy for advanced disease and had measurable or non measurable disease as defined by RECIST version 1.1. Endocrine therapy in the neoadjuvant or adjuvant setting was permitted if the patient had a disease-free interval of more than 12m from the completion of endocrine therapy. An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 and adequate organ function were also required. Key exclusion criteria were visceral crisis and prior treatment with a CDK4/6 inhibitor.

Who may be able to join

  • Patients previously randomized in the PARSIFAL trial (N = 486).
  • Patients did not withdraw consent to participate in the PARSIFAL clinical trial.
  • Patients randomized in PARSIFAL trial had to meet the following inclusion criteria:
  • Postmenopausal women, as defined by any of the following criteria:
  • Age 60 or over
  • Age 45 to 59 years and meets ≥1 of the following criteria: amenorrhea for ≥ 24 months or amenorrhea for < 24 months and follicle-stimulating hormone within the postmenopausal range (including patients with hysterectomy, prior hormone replacement therapy or chemotherapy-induced amenorrhea).
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  • Over 18 years of age and bilateral oophorectomy
  • OR:
  • Premenopausal women provided they are being treated with LHRH analogues for at least 28 days prior to study entry.
  • Eastern Cooperative Oncology Group (ECOG) score lower or equal to 2.
  • Histologically confirmed recurrent ER-positive (oestrogen and/or progesterone) HER2-negative locally advanced or metastatic BC patients (Breast cancer that have at least 1% of cells staging positive for ER should be considered ER-positive according to National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) guidelines.
  • Patients should not be candidates for a local treatment with a radical intention.
  • No prior hormonal or chemotherapy line in the metastatic setting.
  • Patient must have measurable (according to RECIST 1.1) or non-measurable disease with these exceptions:
  • Patients with only blastic bone lesions are not eligible.
  • Patients with only pleural, peritoneal, or cardiac effusion, or meningeal carcinomatosis are not eligible.
  • Life expectancy grater or equal to 12 weeks.
  • Adequate organ function:
  • Hematological: White blood cell (WBC) count >3.0 x 109/L, absolute neutrophil count (ANC) >1.5 x 109/L, platelet count >75.0 x109/L, and hemoglobin >10.0 g/dL (>6.2 mmol/L)
  • Hepatic: bilirubin < 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) <2.5 times ULN. Patients with ALP ≥2.5 times ULN are eligible if ALP abnormalities are unequivocally related to bone lesions (radiological assessments performed within 4 weeks prior to randomization demonstrated bone metastatic disease).
  • Renal: serum creatinine < 1.5 x ULN.
  • Exhibit patient compliance and geographic proximity that allow for adequate follow-up.
  • Patient has been informed about the nature of study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
  • No other malignancies within the past five years except adequate treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
  • Resolution of all acute toxic effects of prior anti- cancer therapy or surgical procedures to NCI- CTCAE version 4.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
  • Patient has been informed about the translational sub-study and has agreed to participate in the collection of blood and tumor tissue samples by signing the Informed Consent form.

Who cannot join

  • Patients were excluded from the PARSIFAL trial if they met any of the following criteria:
  • ER or HER2 unknown disease.
  • HER2-positive disease based on local laboratory results (performed by immunohistochemistry/FISH)
  • Locally advanced breast cancer candidate for a radical treatment.
  • Prior endocrine therapy in the metastatic setting. (Neo)/Adjuvant endocrine therapy is allowed only if the disease-free interval between the end of endocrine therapy and the appearance of metastases in higher than 12 months.
  • Patients with rapidly progressive visceral disease or visceral crisis.
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  • Have had a major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the study.
  • Patients with an active, bleeding diathesis.
  • Have a serious concomitant systemic disorder (e.g. active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator), previous history of bleeding diathesis, or anti-coagulation treatment (The use of low molecular weight heparin is allowed as long as it is used as prophylaxis).
  • Are unable to swallow tablets.
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption.
  • Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day methylprednisolone equivalent (excluding inhaled steroids).
  • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral oedema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
  • Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any palbociclib excipients.
  • Corrected QT Interval (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 (TdP).
  • Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia).

Trial locations and contacts

36 sites in 6 countries.

36 sites in 6 countries

Spain19 sites

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Universitary Vall D´Hebron

    Barcelona, 08035

  • Institut Català d' Oncologia L'Hospitalet (ICO)

    Barcelona

  • Institut Oncologic Baselga-Hospital Quiron Salud Barcelona

    Barcelona

  • Hospital Universitario de Basurto

    Bilbao, 48013

  • Hospital San Pedro Alcántara

    Cáceres

  • Hospital Provincial de Castellón

    Castellon

  • Hospital Universitario Reina Sofía

    Córdoba, 28091

  • ICO Girona

    Girona

  • Hospital Universitario Juan Ramón Jiménez

    Huelva

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital San Joan de Reus

    Reus, Tarragona

  • CHUS Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Fundación Instituto Valenciano de Oncología (IVO)

    Valencia, 46009

  • Hospital Arnau de Vilanova de Valencia

    Valencia

  • Hospital Lozano Blesa

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

France5 sites

  • Hopital Tenon

    Paris

  • Hospital Europeo Georges Pompidou AP-HP

    Paris

  • Institut Curie

    Paris

  • Centre Paul Strauss

    Strasbourg, 67000

  • Institut Universitaire du Cancer Toulouse, Toulouse

    Toulouse

Other trials in France

United Kingdom5 sites

  • Royal United Hospitals Bath NHS Foundation Trust

    Bath

  • Barts Cancer Institute

    London

  • Nottingham University Hospitals NHS Trust

    Nottingham

  • Abertawe Bro Morgannwg University Local Health Board, Singleton Hospital

    Swansea, SA127BR

  • Royal Cornwall Hospital NHS Trust

    Truro

Other trials in United Kingdom

Italy4 sites

  • Istituti Ospitalieri Cremona

    Cremona

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

    Milan

  • Instituto Europeo di Oncologia

    Milan, 20141

  • Ospedale San Gerardo

    Monza

Other trials in Italy

Czechia2 sites

  • Onkologická klinika Fakultní nemocnice Olomouc

    Olomouc

  • General University Hospital in Prague

    Prague

Other trials in Czechia

Germany1 site

  • Klinikum Dessau (MVZ) - Frauenheilkunde

    Dessau

Other trials in Germany

About this study

Official title: Study to Evaluate the Extended Overall Survival From PARSIFAL Trial: Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patient With HER2-/ER+ Metastatic Breast Cancer (The PARSIFAL-LONG Study)

The goal of this study is to evaluate the extended Overall Survival (OS) from PARSIFAL trial - NCT02491983 focused on the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with Human Epidermal growth factor Receptor 2 (HER2)-negative, Endocrine Receptor (ER)-positive metastatic breast cancer. It was designed to test the superiority of fulvestrant plus palbociclib compared with letrozole plus palbociclib first and then the non-inferiority of fulvestrant plus palbociclib compared with letrozole plus palbociclib if the superiority objective was not achieved.

Read the detailed description

This is an observational, international multi-center study with the objective to evaluate the extended overall survival from PARSIFAL trial (NCT02491983) analyzing the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with HER2-negative, ER-positive locally advanced or metastatic breast cancer. The patients included in this trial were previously randomized in PARSIFAL trial and did not withdraw consent to participate in the PARSIFAL clinical trial. The primary objective is to compare the efficacy (in terms of OS) of palbociclib in combination with fulvestrant (interventional arm) versus palbociclib plus letrozole (control arm) during extended follow-up of PARSIFAL trial and the secondary objectives are to assess the extended efficacy, of palbociclib combined with fulvestrant or letrozole in terms of progression-free survival (PFS), to estimate the extended efficacy, of palbociclib combined with endocrine therapy (fulvestrant or letrozole) in terms of OS and PFS and to assess the subsequent antineoplastic therapies to palbociclib combined with fulvestrant or letrozole in this population. The PARSIFAL-LONG study is non-interventional. There are no protocol-mandated visits or procedures associated with the study. In this study the data required to document the defined study endpoints will be collected using the medical histories of patients accrued in the PARSIFAL study as data source. This additional data will be analyzed along with the database of PARSIFAL trial. The estimated study duration is 24 months and the expected period for data validation, analysis, and reporting is around 4 more months.

Being tested
Fulvestrant Injectable Product, Letrozole 2.5mg, Palbociclib 125mg
Keywords
breast cancer, metastatic breast cancer, luminal 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.

  • Fulvestrant Injectable ProductDrug

    Also called Faslodex®

    500 mg fulvestrant on days 1, 14, 28, and once monthly thereafter, administered intramuscularly.

  • Letrozole 2.5mgDrug

    Also called Letrozole

    2.5 mg letrozole per day, administered orally (continuous treatment)

  • Palbociclib 125mgDrug

    Also called PD-0332991

    orally administration 125 mg palbociclib per day (in cycles of 3 weeks of treatment followed by 1 week off)

Study groups in NCT06525675
Study groupRoleWhat they receive
Fulvestrant plus palbociclib (interventional arm)Postmenopausal women and premenopausal women receiving Luteinizing Hormone-Releasing Hormone (LHRH) analogues, aged ≥ 18 years with ER positive and HER2 negative locally advanced or metastatic breast cancer that had not received any therapy for the metastatic disease. Patients are not eligible if they are candidates for a local treatment with a radical intention. Subjects must have histologic confirmation of the estrogen and/or progesterone-positive and HER2 negative receptors breast cancer. Evidence of measurable or evaluable metastatic disease is required.
Receives: Drug: Fulvestrant Injectable Product; Drug: Palbociclib 125mg
Letrozole plus palbociclib (control arm)Postmenopausal women and premenopausal women receiving Luteinizing Hormone-Releasing Hormone (LHRH) analogues, aged ≥ 18 years with ER positive and HER2 negative locally advanced or metastatic breast cancer that had not received any therapy for the metastatic disease. Patients are not eligible if they are candidates for a local treatment with a radical intention. Subjects must have histologic confirmation of the estrogen and/or progesterone-positive and HER2 negative receptors breast cancer. Evidence of measurable or evaluable metastatic disease is required.
Receives: Drug: Letrozole 2.5mg; Drug: Palbociclib 125mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from randomization until death from any cause in the palbociclib plus fulvestrant group versus the palbociclib plus letrozole group

    Measured: 24 months

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    Progression Free Survival (PFS) is defined as the time from randomization until objective tumor progression or death, as assessed by the investigator per RECIST v1.1, in the palbociclib plus fulvestrant group versus the palbociclib plus letrozole group

    Measured: 24 months

  2. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from randomization until death from any cause, in the palbociclib plus endocrine therapy (fulvestrant or letrozole) treated patients

    Measured: 24 months

  3. Progression Free Survival (PFS)

    Progression Free Survival (PFS) is defined as the time from randomization until objective tumor progression or death, as assessed by the investigator per RECIST v1.1, in the palbociclib plus endocrine therapy (fulvestrant or letrozole) treated patients

    Measured: 24 months

  4. Number of patients with the same subsequent antineoplastic therapy

    Number of patients with the same subsequent antineoplasic therapy is described as the number of patients with the same antineoplastic therapy administered after the end of the treatment with palbociclib combined with endocrine therapy (fulvestrant or letrozole).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start18 Jul 2022
  3. Primary completion26 May 2024
  4. Study completion2 Sep 2024

Resources

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
Retrospective
Enrolment
419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06525675
Sponsor's protocol ID
MEDOPP507
Status last verified
Jul 2024
First submitted
18 Jul 2024
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer and Advanced Breast Cancer, run by MedSIR at 36 sites in 6 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 26 inclusion and 16 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 13 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 36 sites in Spain, France, United Kingdom, Italy, Czechia and 1 more country. 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?

Overall Survival (OS) (time frame: 24 months). 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 NCT06525675.

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 13 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.

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