Breast Cancer Stage IVPALATINENCT03870919
Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
A study testing Palbociclib and locoregional treatment in people with Breast Cancer Stage IV and Radiotherapy, run by UNICANCER at 26 sites in France.
Trial summary
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2ⁿᵈ leading cause of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage IV, Radiotherapy, Surgery
- What is being tested?
- Palbociclib and locoregional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 26 sitesFrance
- Study dates
- 23 Oct 2019to 23 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 with newly diagnosed and histologically proven de novo adenocarcinoma of the breast, Any T, any N, with at least one metastatic site measurable and/or non-measurable according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 and/or PET Response Criteria in Solid Tumours (PERCIST) v1.0 and/or MD Anderson bone response criteria (MDA criteria). For patients with only bone metastases, at least one lytic and non-irradiated lesion must be present NB: Bilateral breast cancer is allowed only if tumours present similar histological criteria (morphological subtype, ER and HER2 status).
- Estrogen Receptor (ER)-positive and HER2-negative breast cancer. To be considered as ER-positive, the biopsy of the primary tumour must display at least 10% of cancer cells with positive ER staining. HER2-positive is defined as IHC3+ or FISH/CISH amplified according to 2018 criteria
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) ≤2
- Indication for treatment with palbociclib and letrozole (with or without ovarian suppression)
- Diagnostic FFPE tumour sample and/or frozen primary breast tumour sample available
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- Women of childbearing potential must have a negative serum or urine pregnancy test done within 14 days before inclusion
- Patients must agree to use adequate contraception methods for the duration of the study and for within 21 days after completing treatment
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including absence of co-morbidities preventing surgery and or radiotherapy and any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be discussed with the patient before registration in the trial
- Patient affiliated to a social security system
- Written informed consent obtained prior to performing any protocol-related procedures including screening evaluations
Who cannot join
- Patients with advanced, symptomatic, visceral spread at a risk for short-term, life-threatening complications according to investigator judgement and at risk for visceral crisis as defined by ABC4*
- Women with previously diagnosed and treated ipsilateral adenocarcinoma of the breast
- Women with previously treated or concomitant contralateral breast cancer except for Ductal carcinoma in situ (DCIS) treated with curative intent
- Patients with another concomitant cancer
- Concurrent enrolment in another clinical trial in which investigational therapies are administered or administration of an investigational drug within 30 days before inclusion
- Pregnant women or women who are breast-feeding
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- Inability or willingness to swallow oral medication
- HIV, hepatitis (B and C)
- Active infection
- Prior therapy for metastatic breast cancer (systemic or local)
- Persons deprived of their freedom or under guardianship or incapable of giving consent
- Visceral crisis is defined as severe organ dysfunction as assessed by signs and symptoms, laboratory studies and rapid progression of disease. Visceral crisis is not the mere presence of visceral metastases but implies important visceral compromise leading to a clinical indication for a more rapidly efficacious therapy, particularly since another treatment option at progression will probably not be possible.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Institut de Cancérologie de l'Ouest-Site Paul Papin
Angers, 49005
Institut Sainte Catherine
Avignon, 84818
Centre François Baclesse
Caen
Hôpital privé sainte Marie
Chalon-sur-Saône, 71100
CH Cholet
Cholet, 49300
Centre Jean Perrin
Clermont-Ferrand, 63000
Centre George François Leclerc
Dijon, 21000
Centre Léon Bérard
Lyon, 69008
Hôpital St Joseph
Marseille, 13008
Institut Paoli Calmettes
Marseille, 13009
Hôpital saint Eloi CHU Montpellier
Montpellier, 34090
ICM Val d'Aurelle
Montpellier, 34298
Institut Curie Site Paris
Paris, 75005
Hôpital Saint Louis APHP
Paris, 75010
Hôpital St Joseph
Paris, 75014
Hôpital Tenon
Paris, 75020
Centre Hospitalier de Pau
Pau, 64000
CH René Dubos
Pontoise, 95000
Institut Jean Godinot
Reims, 51726
Centre Eugène Marquis
Rennes, 35042
Institut Curie Hôpital René Huguenin
Saint-Cloud, 92210
Hôpital Privé à Saint Grégoire
Saint-Grégoire, 35760
GCS RISSA - Institut de cancérologie Paris Nord
Sarcelles, 95200
Institut Claudius Regaud
Toulouse, 31059
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Gustave Roussy
Villejuif, 94800
About this study
Official title: PALbociclib in Advanced Breast Cancer: Therapy INtegrating locorEgional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after lung cancer and the world's leading cause.
In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone receptor (HR)-positive / HER2-negative breast cancer.
Read more
The most important current treatment for metastatic breast cancer remains systemic therapy. Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS. These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy. Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor.
Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results. This can be explained by a limited power of statistical analysis, on the recruitment of patients with breast cancer of all types, and on a limited access to effective systemic therapies in some cases and all before the area of anti CD4/6 which is the current standard treatment in patients with HR-positive / HER2-negative luminal metastatic disease.
However, guidelines indicate that a "multimodal approach, including curative locoregional treatments, should be considered". As a result, many clinicians offer locoregional treatment of the primary tumor, especially if there is a good response to the first line of systematic treatment.
Taken together, these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive / HER2-negative breast cancer.
- Conditions
- Breast Cancer Stage IV, Radiotherapy, Surgery
- Being tested
- Palbociclib, locoregional treatment
- Keywords
- therapies combination
- 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
The included patients will first receive the following systemic treatment according standard of care:
- Non-steroidal aromatase inhibitor (letrozole)
- Palbociclib
- Monthly Luteinizing hormone-releasing hormone (LHRH) analogue for non-menopausal patients only. Surgical bilateral oophorectomy is an acceptable option.
locoregional treatmentOther
After normally 6 courses of systemic treatment initiation, the loco-regional treatment of the primary tumour will be performed: surgery (conservative or mastectomy) with or without radiotherapy, or radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib + locoregional treatment | Other | All patients will receive the standard of care treatment ie Palbociclib + letrozole for 24-26 weeks (a delay of +/- 2 weeks to initiate the locoregional treatment is authorized after the day 1 of cycle 1 of palbociclib plus letrozole). After this period, patient will have the most adapted locoregional treatment ie surgery (conservative or mastectomy) with or without radiotherapy, or radiotherapy. The palbociclib will be continued until progression Receives: Drug: Palbociclib; Other: locoregional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate in patients receiving the letrozole plus palbociclib combination plus locoregional treatment
Overall survival
Measured: 24 months
Secondary outcomes (11)
Clinical response rate on both primary tumour and metastasis disease
Follow-up of the disease status by imaging exams until surgery
Measured: 24 months
Pathological response rate in primary tumour
Pathological response (tumour size, cellularity... ) evaluated at the surgery or at the biopsy
Measured: 26 weeks
Conversion rate of breast surgery (conservative-radical)
Rate of modification of indication of mastectomy
Measured: 26 weeks
Locoregional control rate
Rate of locoregional recurrence after surgery and/or radiotherapy
Measured: 60 months
Progression-free survival (PFS)
Follow-up of the disease status by imaging exams
Measured: 60 months
Overall survival
Measured: 60 months
Incidence of combined therapies in terms of adverse events
Will be evaluated using the National Cancer Institute - common terminology criteria for adverse events (NCI-CTCAE) v5.0
Measured: 60 months
Registration of post letrozole-CDKi therapies
Records of cancer treatments prescribed to patients after disease progression
Measured: 60 months
Evolution of quality of life during treatment
self-administered questionnaire of quality of life EORTC QLQ-C30 taking into account the patient's activity and his/her physical and psychological state
Measured: 60 months
Evolution of quality of life during treatment
self-administered questionnaire of quality of life EORTC QLQ-BR23, complementary module to QLQ C30 questionnaire, is more specifically interested in patients with se cancer and the impact of treatment on their lives
Measured: 60 months
Evolution of quality of life during treatment
self-administered questionnaire of quality of life Euroquol EQ-5D-5L consists of a descriptive system and a visual scale
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start23 Oct 2019
- Primary completion18 Aug 2024
- Study completion23 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870919
- Sponsor's protocol ID
- UC-0140/1814
- Other IDs
- 2019-A00570-57
- Acronym
- PALATINE
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2019
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PALbociclib in Advanced Breast Cancer: Therapy INtegrating locorEgional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03870919
- Acronym / sponsor ID
- PALATINE / UC-0140/1814
- Conditions
- Breast Cancer Stage IV, Radiotherapy, Surgery
- Keywords
- therapies combination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 18 Aug 2024 (actual)
- Study completion
- 23 Oct 2027 (estimated)
- First posted
- 12 Mar 2019 (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.
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after lung cancer and the world's leading cause.
In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone receptor (HR)-positive / HER2-negative breast cancer.
The most important current treatment for metastatic breast cancer remains systemic therapy. Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS. These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy. Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor.
Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results. This can be explained by a limited power of statistical analysis, on the recruitment of patients with breast cancer of all types, and on a limited access to effective systemic therapies in some cases and all before the area of anti CD4/6 which is the current standard treatment in patients with HR-positive / HER2-negative luminal metastatic disease.
However, guidelines indicate that a "multimodal approach, including curative locoregional treatments, should be considered". As a result, many clinicians offer locoregional treatment of the primary tumor, especially if there is a good response to the first line of systematic treatment.
Taken together, these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive / HER2-negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib + locoregional treatment | Other | Drug: Palbociclib, Other: locoregional treatmentAll patients will receive the standard of care treatment ie Palbociclib + letrozole for 24-26 weeks (a delay of +/- 2 weeks to initiate the locoregional treatment is authorized after the day 1 of cycle 1 of palbociclib plus letrozole). After this period, patient will have the most adapted locoregional treatment ie surgery (conservative or mastectomy) with or without radiotherapy, or radiotherapy. The palbociclib will be continued until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women with newly diagnosed and histologically proven de novo adenocarcinoma of the breast, Any T, any N, with at least one metastatic site measurable and/or non-measurable according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 and/or PET Response Criteria in Solid Tumours (PERCIST) v1.0 and/or MD Anderson bone response criteria (MDA criteria). For patients with only bone metastases, at least one lytic and non-irradiated lesion must be present NB: Bilateral breast cancer is allowed only if tumours present similar histological criteria (morphological subtype, ER and HER2 status).
- Estrogen Receptor (ER)-positive and HER2-negative breast cancer. To be considered as ER-positive, the biopsy of the primary tumour must display at least 10% of cancer cells with positive ER staining. HER2-positive is defined as IHC3+ or FISH/CISH amplified according to 2018 criteria
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) ≤2
- Indication for treatment with palbociclib and letrozole (with or without ovarian suppression)
Key exclusion criteria (12 listed)
- Patients with advanced, symptomatic, visceral spread at a risk for short-term, life-threatening complications according to investigator judgement and at risk for visceral crisis as defined by ABC4*
- Women with previously diagnosed and treated ipsilateral adenocarcinoma of the breast
- Women with previously treated or concomitant contralateral breast cancer except for Ductal carcinoma in situ (DCIS) treated with curative intent
- Patients with another concomitant cancer
- Concurrent enrolment in another clinical trial in which investigational therapies are administered or administration of an investigational drug within 30 days before inclusion
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 |
|---|---|---|
| PalbociclibThe included patients will first receive the following systemic treatment according standard of care: * Non-steroidal aromatase inhibitor (letrozole) * Palbociclib * Monthly Luteinizing hormone-releasing hormone (LHRH) analogue for non-menopausal patients only. Surgical bilateral oophorectomy is an acceptable option. | Drug | Palbociclib + locoregional treatment |
| locoregional treatmentAfter normally 6 courses of systemic treatment initiation, the loco-regional treatment of the primary tumour will be performed: surgery (conservative or mastectomy) with or without radiotherapy, or radiotherapy | Other | Palbociclib + locoregional treatment |
Primary outcome
Overall survival rate in patients receiving the letrozole plus palbociclib combination plus locoregional treatment
Time frame: 24 months
Overall survival
11 secondary outcomes
Clinical response rate on both primary tumour and metastasis disease
Time frame: 24 months
Pathological response rate in primary tumour
Time frame: 26 weeks
Conversion rate of breast surgery (conservative-radical)
Time frame: 26 weeks
Locoregional control rate
Time frame: 60 months
Progression-free survival (PFS)
Time frame: 60 months
Overall survival
Time frame: 60 months
Incidence of combined therapies in terms of adverse events
Time frame: 60 months
Registration of post letrozole-CDKi therapies
Time frame: 60 months
Evolution of quality of life during treatment
Time frame: 60 months
Evolution of quality of life during treatment
Time frame: 60 months
Evolution of quality of life during treatment
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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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.
Claire Bonneau, MD principal investigator
Institut Curie
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palbociclib and locoregional treatment in people with Breast Cancer Stage IV and Radiotherapy, run by UNICANCER at 26 sites in France.
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 12 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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 rate in patients receiving the letrozole plus palbociclib combination plus locoregional treatment (time frame: 24 months). 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 20 May 2026.