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Breast CancerPhase 2PALMIRANCT03809988

PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)

A Phase 2 study testing Palbociclib and Endocrine therapy in people with Breast Cancer and Advanced Breast Cancer, run by MedSIR at 53 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

Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC) Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Palbociclib and Endocrine therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
53 sitesin 6 countries
Study dates
5 Apr 2019to 30 Nov 2022
Phase
Phase 2
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

Who may be able to join

  • Female patients over 18 years of age.
  • Pre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/Follicle-stimulating hormone (FSH) must be confirmed analytically) prior to study entry or post- menopausal women as defined by any of the following criteria:
  • Age ≥60 years;
  • Age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for postmenopausal females;
  • Documented bilateral oophorectomy.
  • Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1.
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  • Life expectancy greater or equal to 12 weeks.
  • Histologically proven diagnosed of ABC not amenable to curative treatment.
  • Documented recurrent ER-positive and/or progesterone receptor (PgR)-positive (with ≥1% positive stained cells (according to NCCN National Comprehensive Cancer Network and ASCO American Society of Clinical Oncology guidelines) and HER2-negative (0-1+ by immunohistochemistry (IHC) or 2+ and negative by in situ hybridization (ISH) test) breast cancer in the advanced setting.
  • Radiological or clinical evidence of disease progression on first- line combination of palbociclib plus endocrine therapy (aromatase inhibitor (AI) or fulvestrant). Patients previously treated with the combination of palbociclib and tamoxifen will be excluded.
  • Patients have achieved clinical benefit criteria to a first-line palbociclib-based endocrine regimen (defined as at least stable disease ≥ 24 weeks or partial or complete response confirmed or unconfirmed).
  • Patients must have been treated with a stable minimum dose of 75 mg palbociclib during the last 2 cycles of the prior palbociclib-based regimen.
  • Last dose of palbociclib administered not later than 8 weeks and not earlier than 7 days from study entry, with the exception of patients relapsing on a palbociclib-based regimen in the adjuvant setting.
  • Patients should not have been treated in the advanced setting with at least one of these endocrine therapy options: either fulvestrant or AI.
  • Patients must have measurable disease or evaluable disease according to RECIST criteria v.1.1. Patients with only bone lesions are eligible.
  • Willingness and ability to provide tumor biopsy (if feasible) both at the time of the inclusion and after disease progression in order to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee.
  • Patients agree to collection of blood samples (liquid biopsy) at the time of inclusion, after 2 weeks of treatment, and upon progression or study termination.
  • Adequate organ function: (Hematological, hepatic and renal)
  • Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.
  • Resolution of all acute toxic effects of prior anti-cancer therapy to grade 1

Who cannot join

  • HR or HER2 unknown disease.
  • HER2-positive disease based on local laboratory results (performed by IHC / ISH test).
  • Locally ABC candidate for curative treatment.
  • Formal contraindication to endocrine therapy defined as visceral crisis and rapidly or symptomatic progressive visceral disease.
  • Prior therapy with any other CDK4/6 inhibitor different from palbociclib.
  • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
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  • Patients are currently receiving food or drugs known to be strong inducers or inhibitors of CYP3A4.
  • Current or prior malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively- treated non-melanoma skin cancer, non-muscle-invasive bladder cancer, or carcinoma in situ, among others, are generally eligible.
  • No other systemic therapy for metastatic disease including chemotherapy, immunotherapy, targeted therapy (small molecules/ monoclonal antibodies), or endocrine therapy excluding first-line palbociclib-based regimen.
  • Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 2 weeks of start of study drug, or patients who have not recovered from the side effects of any major surgery, or patients who may require major surgery during the study.
  • Radiotherapy or limited-field palliative radiotherapy within 7 days prior to study enrolment, or patients who have not recovered from radiotherapy-related toxicities to baseline or grade ≤ 1 and/or from whom ≥ 25% of the bone marrow has been previously irradiated.
  • Use of concurrent investigational agents or other concomitant anticancer therapies.
  • Active bleeding diathesis, previous history of bleeding diathesis, or chronic anti-coagulation treatment (the use of low molecular weight heparin is allowed as soon as it is used as prophylaxis intention).
  • Serious concomitant systemic disorder (e.g., active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator).
  • Unable to swallow capsules or tablets.
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption.
  • Any of the following within 6 months of randomization:
  • myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI-CTCAE v.5.0 grade ≥2, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
  • Uncontrolled electrolyte disorders of NCI-CTCAE v.5.0 grade ≥ 2.
  • Known hypersensitivity to palbociclib or any of its excipients.

Trial locations and contacts

53 sites in 6 countries.

53 sites in 6 countries

Spain26 sites

  • Centro Oncológico de Galicia

    A Coruña, 15009

  • ICO Badalona

    Badalona, Barcelona

  • Institut Català d'Oncologia Bellvitge

    Barcelona, 08908

  • H. Vall Hebrón

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

  • Hospital Provincial de Castellón

    Castelló, Castelló

  • Institut Català d'Oncologia

    Girona

  • Hospital Arnau de Vilanova

    Lleida

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Sanchinarro

    Madrid, 28050

  • Hospital La Paz

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

  • Hospital Sant Joan

    Reus

  • Hospital Universitario Virgen de la Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocío

    Seville

  • Consorci Sanitari de Terrassa

    Terrassa, Terrasa, 08191

  • Instituto Valenciano de Oncología IVO

    Valencia, 46009

  • Hospital General Universitari de Valencia

    Valencia, 46014

  • Hospital Arnau de Vilanova de Valencia

    Valencia

  • Hospital Universitari i Politecnic La Fe

    Valencia

  • Hospital Álvaro Cunqueiro

    Vigo, 36312

  • Hospital Lozano Blesa

    Zaragoza, 50009

  • Hospital Miguel Servet

    Zaragoza

Other trials in Spain

Germany8 sites

  • University Hospital Dresden-GYN

    Dresden

  • Kliniken Essen Mitte

    Essen

  • Universitätsklinikum Essen Frauenklinik

    Essen

  • AGAPLESION Markus Krankenhaus

    Frankfurt

  • Technical University Munich

    Munich

  • UKM Brustzentrum

    Münster

  • Klinikum Ernst von Bergmann

    Potsdam

  • Klinikum Mutterhaus der Borromäerinnen Trier

    Trier

Other trials in Germany

France7 sites

  • Hôpital Jean Minjoz

    Besançon

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux

  • Centre Georges François Leclerc

    Dijon

  • CHD Vendee

    La Roche-sur-Yon, 85925

  • Hopital Europeen Georges Pompidou

    Paris

  • Hôpital Tenon AP-HP

    Paris

  • Centre Paul Strauss

    Strasbourg, 67000

Other trials in France

United Kingdom6 sites

  • Darent Valley Hospital by Dartford and Gravesham NHS Trust

    Dartford

  • Beatson West of Scotland Cancer Center

    Glasgow, G12 0YN

  • Barts Cancer Institute

    London

  • Kent Oncology Department

    Maidstone, ME16 9QQ

  • Abertawe Bro Morgannwg University Local Health Board, Singleton Hospital

    Swansea, SA127BR

  • Royal Cornwall Hospital NHS Trust

    Truro, TR1 3LQ

Other trials in United Kingdom

Italy4 sites

  • Ospedale Civili Brescia

    Brescia

  • Instituto Europeo di Oncologia

    Milan, 20141

  • Oncologia Medica Ospedale di Prato

    Prato

  • Policlinico Universitario Campus Bio-medico

    Roma

Other trials in Italy

Slovenia2 sites

  • Onkološki Inštitut Ljubljana

    Ljubljana

  • Univerzitetni klinicni center Maribor Oddelek za onkologijo

    Maribor

Other trials in Slovenia

About this study

Official title: International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.

Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)

Read the detailed description

Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH) analogues.

Being tested
Palbociclib, Endocrine therapy
Keywords
HR, breast cancer, ABC, progesterone receptor, HER2, advanced, estrogen receptor
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 capsules orally once daily (QD) (at 100mg or 125mg depending on previous treatment dose) for 21 days every four weeks

  • Endocrine therapyDrug

    Also called letrozole, fulvestrant

    Endocrine therapy alone (letrozole or fulvestrant)

Study groups in NCT03809988
Study groupRoleWhat they receive
Interventional Arm (Arm A)ExperimentalPatients will receive palbociclib capsules orally once daily (QD) (at 100mg or 125mg depending on previous treatment dose) for 21 days every four weeks in combination with endocrine therapy (letrozole or fulvestrant).
Receives: Drug: Palbociclib; Drug: Endocrine therapy
Control Arm (Arm B)Active comparatorPatients will receive endocrine therapy (letrozole or fulvestrant).
Receives: Drug: Endocrine therapy

What is being measured

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

  1. PFS (Progression-free survival)

    From a clinical point of view, the primary endpoint for this study is the PFS (progression-free survival) - defined as the period of time from randomization until objective tumor progression or death - assessed by RECIST criteria v.1.1, of continuation of palbociclib treatment combined with second-line endocrine therapy (letrozole or fulvestrant) versus endocrine therapy in pre- and post- menopausal women with HR-positive/HER2-negative ABC.

    Measured: Baseline up to 29 months

Secondary outcomes (7)

  1. Safety AEs

    Patient safety and adverse events (AEs) will be evaluated using the NCI-CTCAE v.5.0. Grade 3 and 4 AEs and serious adverse events (SAEs) will be assessed to determine the safety and tolerability of the different treatment arms.

    Measured: Baseline up to 29 months

  2. Efficacy (ORR)

    To compare the objective response rate (ORR), the duration of response (DoR), the time to response (TTR), the clinical benefit rate (CBR), the time to progression (TTP), and the overall survival (OS) of palbociclib plus second-line endocrine therapy (letrozole or fulvestrant) versus endocrine therapy alone

    Measured: Baseline up to 29 months

  3. Efficacy (Quality of Life)

    To compare the patient reported global Quality of Life (QOL), functioning and symptoms of palbociclib plus second-line endocrine therapy (letrozole or fulvestrant) versus endocrine therapy alone.

    Measured: Baseline up to 42 months

  4. Efficacy of subgroup analysis

    To perform subgroup analysis for primary and secondary endpoints in stratified groups of patients.

    Measured: Baseline up to 42 months

  5. Compare efficacy

    To compare the time to first chemotherapy of palbociclib plus second-line endocrine therapy (letrozole or fulvestrant) versus endocrine therapy alone.

    Measured: Baseline up to 42 months

  6. Exploratory objectives (molecular markers)

    To explore potential molecular markers of sensitivity and/or resistance for the combination and endocrine therapy alone, according to, but not limited to, the results obtained from the BioPER trial (NCT03184090).

    Measured: Baseline up to 42 months

  7. Exploratory objectives (intrinsic molecular subtypes)

    To explore correlations between the intrinsic molecular subtypes and efficacy/safety findings in patients with HR-positive/HER2- negative ABC.

    Measured: Baseline up to 42 months

Timeline

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

  1. First posted18 Jan 2019
  2. Study start5 Apr 2019
  3. Primary completion30 Nov 2022
  4. Study completion30 Nov 2022

Resources

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
Model description
Randomized 2:1
Masking
None (open label)
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809988
Sponsor's protocol ID
MedOPP068
Other IDs
2017-002781-48, 2017
Acronym
PALMIRA
Status last verified
Sep 2023
First submitted
15 Jan 2019
Last updated
7 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Leaflet V2\_20190115 with study design, primary objetive, inclusion criteria and exclusion criteria

Publications

  • Llombart-Cussac A, Harper-Wynne C, Perello A, Hennequin A, Fernandez-Ortega A, Colleoni M, Marin S, Quiroga V, Medioni J, Iranzo V, Wheatley D, Del Barco Berron S, Anton A, Dobi E, Ruiz-Borrego M, Alcala-Lopez D, Perez-Escuredo J, Antonarelli G, Sampayo-Cordero M, Perez-Garcia JM, Cortes J. Second-Line Endocrine Therapy With or Without Palbociclib Rechallenge in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: PALMIRA Trial. J Clin Oncol. 2025 Jun 20;43(18):2084-2093. doi: 10.1200/JCO-24-01865. Epub 2025 Apr 28.

    PubMed 40294349

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib and Endocrine therapy in people with Breast Cancer and Advanced Breast Cancer, run by MedSIR at 53 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 21 inclusion and 20 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Spain, Germany, France, United Kingdom, Italy 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.

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?

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?

PFS (Progression-free survival) (time frame: Baseline up to 29 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 NCT03809988, which also lists 1 linked publication.

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 7 Sep 2023.

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