Breast Cancer FemalePhase 2NeoRHEANCT03065621
Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer (NeoRHEA)
A Phase 2 study testing Palbociclib in people with Breast Cancer Female, run by Jules Bordet Institute at 5 sites in Belgium.
Trial summary
This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from D1 to D21 followed by a week of rest) combined… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Palbociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesBelgium
- Study dates
- 5 Jul 2017to 1 Feb 2023
- 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
- Age ≥ 18 years
- Histological diagnosis of breast adenocarcinoma that is estrogen receptor-positive, and HER2- negative as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing.
- Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed provided that all tested foci are ER-positive and HER2-negative.
- ER-positive (ER+ is defined as having a IHC of 1% or more and/or and Allred of 2 or more and HER2-negative.
- HER2 negative (HER2 negative is defined as having an IHC of 1+ without ISH OR IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC)
Show all 21Show fewer
- A primary non metastatic or locally advanced tumour of more than 2 cm (T2 or T3), N0 or N1 without prior treatment candidate for preoperative treatment
- ECOG Performance Status (PS) 0 or 1.
- Adequate Bone Marrow Function including:
- Absolute Neutrophil Count (ANC) ≥1500/μL or ≥1.5 x109/L;
- Platelets ≥100000/μL or ≥100 x 109/L;
- Hemoglobin ≥ 9 g/dL.
- Adequate Renal Function including: Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution.
- Adequate Liver Function, including all of the following parameters:
- Total serum bilirubin ≤ 1.0 x ULN unless the subject has documented Gilbert syndrome (in which case up to 3 x ULN is acceptable) ;
- Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 1.5 x ULN;
- Alkaline phosphatase ≤ 2.5 x ULN.
- Signed consent form
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests, radiological exams, tumour and blood specimen collection and other procedures.
- Women who are not postmenopausal or have not undergone hysterectomy must have documented negative pregnancy test (serum) prior to inclusion.
- Female subjects of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 90 days after last dose of study drug, or they must totally/truly abstain from any form of sexual intercourse. Use of oral hormonal contraceptive agents in this study is not permitted.
Who cannot join
- Clinical T4 disease including inflammatory breast cancer.
- Prior history of invasive cancer including breast cancer except basal or squamous cell carcinoma of skin that has been definitively treated.
- Known hypersensitivity to the study drugs or excipients.
- Any illness or medical condition that is unstable or could jeopardize the safety of the subject or her compliance with study requirements.
- Subjects unable to swallow oral medications.
- Prior intake of letrozole, or any CDK inhibitor or anti-cancer therapy.
Show all 10Show fewer
- Concurrent treatment with any of the drugs not permitted, i.e. strong CYP3A inhibitors/inducers and drugs known to cause QTc interval prolongation (see section 5.7 for specific instructions).
- QTc exceeding 480 msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
- Uncontrolled diabetes, according to investigator's clinical judgment.
- Pregnant or lactating women.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Institut Jules Bordet
Anderlecht, 1070
CHU Brugmann
Brussels, 1090
CHU Saint-Luc
Brussels, 1200
UZ Leuven Gasthuisberg
Leuven, 3000
CHU UCL Namur Sainte-Elisabeth
Namur, 5000
About this study
Official title: Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer
This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from D1 to D21 followed by a week of rest) combined with endocrine therapy given continuously (each cycle of endocrine therapy consists of treatment from D1 to D28).
The endocrine therapy will be determined according to the menopausal status of the subject evaluated at the study screening.
Read the detailed description
This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from D1 to D21 followed by a week of rest) combined with endocrine therapy given continuously (each cycle of endocrine therapy consists of treatment from D1 to D28).
The endocrine therapy will be determined according to the menopausal status of the subject evaluated at the study screening.
For post-menopausal subjects: endocrine therapy will consist of letrozole 2.5 mg continuously.
For pre-menopausal or peri-menopausal subjects: endocrine therapy will consist of tamoxifen 20 mg continuously, combined or not with goserelin 3.6 mg monthly at the local investigator's discretion.
Endocrine therapy for both groups should continue until the last day of palbociclib treatment (i.e. the day before surgery).
Subject's response to therapy will be evaluated before and after the 4 cycles of treatment by ultrasound to determine response to therapy. Post treatment ultrasound should be performed 7 to 10 days before surgery (with a maximum delay of 3 days in case of delayed surgery date).
Surgery will be performed 4 to 8 days after the end of the 4th cycle of study treatment.
Biopsy samples will be collected after the subject's inclusion in the study and prior to Day 1 Cycle 1 of study treatment (pre-treatment biopsy) and will consist of collection of 4 core biopsies (2 FFPE and 2 Frozen).
FFPE and frozen material will be collected from the surgical material left over, after sufficient and relevant parts has been retained to establish, improve or complement the diagnosis or treatment of the subject.
One whole blood sample (1x10 mL) will also be collected after the subject's inclusion and prior to Day 1 Cycle 1 of study treatment.
Blood samples for plasma processing (4x10 mL per time point) will be collected after the subject's inclusion and prior to Day 1 Cycle 1, prior to Day 1 Cycle 2 of study treatment, at surgery day (prior surgery) and one month after surgery.
All the biological samples collected (pre-treatment biopsy, material from surgery and all blood samples) within the study are mandatory. The breast biopsy samples as well as imaging tumour assessment (ultrasound breast) performed prior to the signature of the study ICF are not admissible for assessment of study end-points and should be repeated within the required study time window.
Information on patient survival and disease recurrence will be collected at least 30 months from the date of the end of study treatment (i.e., last visit of the last subject one month after surgery day, see definition in paragraph 11.3). Data collection will be made based on medical charts if a follow up visit was performed not earlier than February 2022. If the data is missing from medical charts (i.e. loss of follow up), a phone call to the subject's general practitionerwill be made.
Primary objective :
- To identify biomarkers of resistance to a 4-month preoperative treatment of palbociclib plus endocrine therapy defined as stable or progressive disease by ultrasound (based on WHO criteria) using RNA-seq of the baseline tumour biopsy.
Secondary objectives :
- To identify biomarkers of resistance to a 4-month preoperative treatment of endocrine therapy and palbociclib by correlating tumour response by ultrasound (mandatory) or magnetic resonance (optional) imaging (response will be assessed as continuous or categorical variable) with RNA-seq of the baseline tumour biopsy
- To identify biomarkers of resistance to a 4-month preoperative treatment of palbociclib plus endocrine therapy defined as residual disease burden, RCB of 3 using RNA-seq of the baseline tumour biopsy
- To identify biomarkers of resistance to a 4-month preoperative treatment of endocrine therapy and palbociclib defined as GGI high by RNA-seq of the residual tumour at surgery using RNA-seq of the baseline tumour biopsy
- To understand mechanisms of resistance to the combination of endocrine therapy and palbociclib by comparing the transcriptome of tumours at baseline and at surgery using RNA-seq
- To evaluate the safety of the combination of palbociclib plus endocrine therapy
- To evaluate the role of plasma ctDNA in monitoring response/resistance to pre-operative treatment with endocrine therapy and palbociclib
- To validate/further refine an 11-gene expression signature associated with response/resistance to palbociclib and endocrine treatment
Exploratory objectives:
- To compare changes in clonal composition, transcriptomic changes and changes in the open chromatin state of tumour cells using a combined genomic and transcriptomic (G\&T) single tumour cell analysis and chromatin accessibility single tumour cell analysis of exceptional responders and exceptional non-responders. Based on the above results, additional bulk or single cell analyses in the entire study cohort could be performed.
- To evaluate associations between patient survival (distant relapse-free survival, relapse-free survival, invasive disease-free survival, overall survival) and the following :
- Tumor clinicopathological characteristics and other biomarkers at baseline and/or surgery and/or their changes
- Plasma ctDNA monitoring
- Conditions
- Breast Cancer Female
- Being tested
- Palbociclib
- Keywords
- Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called PD-0332991, Ibrance
Each cycle will be 28 days. Patient will take study drug daily during 21 days and then have a rest period of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib with Endocrine Therapy | Experimental | All subjects will receive palbociclib 125 mg for 4 cycles, orally, once a day, for 21 days followed by 7 days of rest (4 cycles of 28 day long). After the final rest week (therefore post cycle 4), subjects will receive 3 to 7 additional days of palbociclib, as necessary, at the same dose and posology, until the day before curative intent surgery. Depending upon the menopausal status, the patient will receive either letrozole or tamoxifen continuously during the palbociclib treatment (which consists of 4 cycles of 28 days). Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify biomarkers of resistance to a 4-month preoperative treatment of palbociclib plus endocrine therapy defined as stable or progressive disease by ultrasound (based on WHO criteria) using RNA-seq of the baseline tumour biopsy
- Baseline transcriptomic profile of resistance to 4 months of palbociclib and endocrine therapy defined as stable or progressive disease by ultrasound based on WHO criteria
Measured: 4 Months
Secondary outcomes (9)
To identify biomarkers of resistance to a 4-month preoperative treatment of endocrine therapy and palbociclib by correlating tumour response by ultrasound (mandatory) or magnetic resonance (optional) imaging
- Baseline transcriptomic profile of resistance to 4 months of palbociclib and endocrine therapy assessed by ultrasound (mandatory) or magnetic resonance (optional) imaging (response will be assessed as continuous or categorical variable)
Measured: 4 Months
To identify biomarkers of resistance to a 4-month preoperative treatment of palbociclib plus endocrine therapy defined as residual disease burden, RCB of 3 using RNA-seq of the baseline tumour biopsy
- Baseline transcriptomic profile of resistance to 4 months of palbociclib and endocrine therapy, defined as an RCB of 3.
Measured: 4 Months
To identify biomarkers of resistance to a 4-month preoperative treatment of endocrine therapy and palbociclib defined as GGI high by RNA-seq of the residual tumour at surgery using RNA-seq of the baseline tumour biopsy
- Baseline transcriptomic profile of resistance to 4 months of palbociclib and endocrine therapy, defined as an GGI high at surgery
Measured: 4 Months
To understand mechanisms of resistance to the combination of endocrine therapy and palbociclib by comparing the transcriptome of tumours at baseline and at surgery using RNA-seq
- Transcriptomic changes between pre-treatment and post-treatment tumour samples
Measured: 4 Months
To evaluate the safety of the combination of palbociclib plus endocrine therapy as assessed by the NCI-CTCAE version 4.03
Safety
Measured: 4 Months
The role of plasma ctDNA in monitoring response/resistance to pre-operative treatment with endocrine therapy and palbociclib
- Plasma ctDNA analysis to monitor response/resistance to pre-operative treatment with endocrine therapy and palbociclib
Measured: 4 Months
To refine an 11-gene expression signature associated with response/resistance to palbociclib and endocrine treatment
- Validation of 11-gene expression signature associated with response/resistance to palbociclib and endocrine treatment
Measured: 4 Months
To determine the effect of a pre-operative treatment with endocrine therapy and palbociclib on anti-tumour immune response
- Changes in anti-tumour immune response between pre- and post-treatment tumour samples
Measured: 4 Months
To determine the effect of a pre-operative treatment with endocrine therapy and palbociclib on tumour senescence
- Changes in tumour senescence between pre- and post-treatment tumour samples
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start5 Jul 2017
- Primary completion28 Mar 2019
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michail Ignatiadis, MD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065621
- Sponsor's protocol ID
- IJB-BC-NEORHEA-2016
- Acronym
- NeoRHEA
- Status last verified
- Aug 2020
- First submitted
- 12 Jan 2017
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papagiannis A, Majjaj S, Duhoux FP, Agostinetto E, Stanciu AM, Vanhulst T, Buisseret L, Larsimont D, Veys I, Paesmans M, Hammer TB, Awada A, Ameye L, Rothe F, Madriles F, Cash TP, Salgado R, Willard-Gallo K, Sotiriou C, Vuylsteke P, Neven P, Ignatiadis M. Palbociclib and endocrine therapy diminish adaptive anti-tumor immunity in early breast cancer: The NeoRHEA phase 2 study. Nat Commun. 2025 Nov 26;16(1):11659. doi: 10.1038/s41467-025-66590-2.
PubMed 41298425Brandao M, Coens C, Ignatiadis M. Patient-reported outcomes and genomic signatures: tools to tailor adjuvant endocrine treatment? Ann Oncol. 2019 Nov 1;30(11):1677-1681. doi: 10.1093/annonc/mdz404. No abstract available.
PubMed 31613310
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer
- ClinicalTrials.gov ID
- NCT03065621
- Acronym / sponsor ID
- NeoRHEA / IJB-BC-NEORHEA-2016
- Conditions
- Breast Cancer Female
- Keywords
- Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Feb 2017 (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 an open-label, single arm, phase 2 trial that will include pre or post-menopausal female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from D1 to D21 followed by a week of rest) combined with endocrine therapy given continuously (each cycle of endocrine therapy consists of treatment from D1 to D28).
The endocrine therapy will be determined according to the menopausal status of the subject evaluated at the study screening.
Detailed description
This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from D1 to D21 followed by a week of rest) combined with endocrine therapy given continuously (each cycle of endocrine therapy consists of treatment from D1 to D28).
The endocrine therapy will be determined according to the menopausal status of the subject evaluated at the study screening.
For post-menopausal subjects: endocrine therapy will consist of letrozole 2.5 mg continuously.
For pre-menopausal or peri-menopausal subjects: endocrine therapy will consist of tamoxifen 20 mg continuously, combined or not with goserelin 3.6 mg monthly at the local investigator's discretion.
Endocrine therapy for both groups should continue until the last day of palbociclib treatment (i.e. the day before surgery).
Subject's response to therapy will be evaluated before and after the 4 cycles of treatment by ultrasound to determine response to therapy. Post treatment ultrasound should be performed 7 to 10 days before surgery (with a maximum delay of 3 days in case of delayed surgery date).
Surgery will be performed 4 to 8 days after the end of the 4th cycle of study treatment.
Biopsy samples will be collected after the subject's inclusion in the study and prior to Day 1 Cycle 1 of study treatment (pre-treatment biopsy) and will consist of collection of 4 core biopsies (2 FFPE and 2 Frozen).
FFPE and frozen material will be collected from the surgical material left over, after sufficient and relevant parts has been retained to establish, improve or complement the diagnosis or treatment of the subject.
One whole blood sample (1x10 mL) will also be collected after the subject's inclusion and prior to Day 1 Cycle 1 of study treatment.
Blood samples for plasma processing (4x10 mL per time point) will be collected after the subject's inclusion and prior to Day 1 Cycle 1, prior to Day 1 Cycle 2 of study treatment, at surgery day (prior surgery) and one month after surgery.
All the biological samples collected (pre-treatment biopsy, material from surgery and all blood samples) within the study are mandatory. The breast biopsy samples as well as imaging tumour assessment (ultrasound breast) performed prior to the signature of the study ICF are not admissible for assessment of study end-points and should be repeated within the required study time window.
Information on patient survival and disease recurrence will be collected at least 30 months from the date of the end of study treatment (i.e., last visit of the last subject one month after surgery day, see definition in paragraph 11.3). Data collection will be made based on medical charts if a follow up visit was performed not earlier than February 2022. If the data is missing from medical charts (i.e. loss of follow up), a phone call to the subject's general practitionerwill be made.
Primary objective :
- To identify biomarkers of resistance to a 4-month preoperative treatment of palbociclib plus endocrine therapy defined as stable or progressive disease by ultrasound (based on WHO criteria) using RNA-seq of the baseline tumour biopsy.
Secondary objectives :
- To identify biomarkers of resistance to a 4-month preoperative treatment of endocrine therapy and palbociclib by correlating tumour response by ultrasound (mandatory) or magnetic resonance (optional) imaging (response will be assessed as continuous or categorical variable) with RNA-seq of the baseline tumour biopsy
- To identify biomarkers of resistance to a 4-month preoperative treatment of palbociclib plus endocrine therapy defined as residual disease burden, RCB of 3 using RNA-seq of the baseline tumour biopsy
- To identify biomarkers of resistance to a 4-month preoperative treatment of endocrine therapy and palbociclib defined as GGI high by RNA-seq of the residual tumour at surgery using RNA-seq of the baseline tumour biopsy
- To understand mechanisms of resistance to the combination of endocrine therapy and palbociclib by comparing the transcriptome of tumours at baseline and at surgery using RNA-seq
- To evaluate the safety of the combination of palbociclib plus endocrine therapy
- To evaluate the role of plasma ctDNA in monitoring response/resistance to pre-operative treatment with endocrine therapy and palbociclib
- To validate/further refine an 11-gene expression signature associated with response/resistance to palbociclib and endocrine treatment
Exploratory objectives:
- To compare changes in clonal composition, transcriptomic changes and changes in the open chromatin state of tumour cells using a combined genomic and transcriptomic (G\&T) single tumour cell analysis and chromatin accessibility single tumour cell analysis of exceptional responders and exceptional non-responders. Based on the above results, additional bulk or single cell analyses in the entire study cohort could be performed.
- To evaluate associations between patient survival (distant relapse-free survival, relapse-free survival, invasive disease-free survival, overall survival) and the following :
- Tumor clinicopathological characteristics and other biomarkers at baseline and/or surgery and/or their changes
- Plasma ctDNA monitoring
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib with Endocrine Therapy | Experimental | Drug: PalbociclibAll subjects will receive palbociclib 125 mg for 4 cycles, orally, once a day, for 21 days followed by 7 days of rest (4 cycles of 28 day long). After the final rest week (therefore post cycle 4), subjects will receive 3 to 7 additional days of palbociclib, as necessary, at the same dose and posology, until the day before curative intent surgery. Depending upon the menopausal status, the patient will receive either letrozole or tamoxifen continuously during the palbociclib treatment (which consists of 4 cycles of 28 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Female
- Age ≥ 18 years
- Histological diagnosis of breast adenocarcinoma that is estrogen receptor-positive, and HER2- negative as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing.
- Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed provided that all tested foci are ER-positive and HER2-negative.
- A primary non metastatic or locally advanced tumour of more than 2 cm (T2 or T3), N0 or N1 without prior treatment candidate for preoperative treatment
Key exclusion criteria (10 listed)
- Clinical T4 disease including inflammatory breast cancer.
- Prior history of invasive cancer including breast cancer except basal or squamous cell carcinoma of skin that has been definitively treated.
- Known hypersensitivity to the study drugs or excipients.
- Any illness or medical condition that is unstable or could jeopardize the safety of the subject or her compliance with study requirements.
- Subjects unable to swallow oral medications.
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, IbranceEach cycle will be 28 days. Patient will take study drug daily during 21 days and then have a rest period of 7 days. | Drug | Palbociclib with Endocrine Therapy |
Primary outcome
To identify biomarkers of resistance to a 4-month preoperative treatment of palbociclib plus endocrine therapy defined as stable or progressive disease by ultrasound (based on WHO criteria) using RNA-seq of the baseline tumour biopsy
Time frame: 4 Months
• Baseline transcriptomic profile of resistance to 4 months of palbociclib and endocrine therapy defined as stable or progressive disease by ultrasound based on WHO criteria
9 secondary outcomes
To identify biomarkers of resistance to a 4-month preoperative treatment of endocrine therapy and palbociclib by correlating tumour response by ultrasound (mandatory) or magnetic resonance (optional) imaging
Time frame: 4 Months
To identify biomarkers of resistance to a 4-month preoperative treatment of palbociclib plus endocrine therapy defined as residual disease burden, RCB of 3 using RNA-seq of the baseline tumour biopsy
Time frame: 4 Months
To identify biomarkers of resistance to a 4-month preoperative treatment of endocrine therapy and palbociclib defined as GGI high by RNA-seq of the residual tumour at surgery using RNA-seq of the baseline tumour biopsy
Time frame: 4 Months
To understand mechanisms of resistance to the combination of endocrine therapy and palbociclib by comparing the transcriptome of tumours at baseline and at surgery using RNA-seq
Time frame: 4 Months
To evaluate the safety of the combination of palbociclib plus endocrine therapy as assessed by the NCI-CTCAE version 4.03
Time frame: 4 Months
The role of plasma ctDNA in monitoring response/resistance to pre-operative treatment with endocrine therapy and palbociclib
Time frame: 4 Months
To refine an 11-gene expression signature associated with response/resistance to palbociclib and endocrine treatment
Time frame: 4 Months
To determine the effect of a pre-operative treatment with endocrine therapy and palbociclib on anti-tumour immune response
Time frame: 4 Months
To determine the effect of a pre-operative treatment with endocrine therapy and palbociclib on tumour senescence
Time frame: 4 Months
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 19 Apr 2023.
- Derived from this study: PubMed 41298425Papagiannis A, Majjaj S, Duhoux FP, Agostinetto E, Stanciu AM, Vanhulst T, Buisseret L, Larsimont D, Veys I, Paesmans M, Hammer TB, Awada A, Ameye L, Rothe F, Madriles F, Cash TP, Salgado R, Willard-Gallo K, Sotiriou C, Vuylsteke P, Neven P, Ignatiadis M. Palbociclib and endocrine therapy diminish adaptive anti-tumor immunity in early breast cancer: The NeoRHEA phase 2 study. Nat Commun. 2025 Nov 26;16(1):11659. doi: 10.1038/s41467-025-66590-2.
- Derived from this study: PubMed 31613310Brandao M, Coens C, Ignatiadis M. Patient-reported outcomes and genomic signatures: tools to tailor adjuvant endocrine treatment? Ann Oncol. 2019 Nov 1;30(11):1677-1681. doi: 10.1093/annonc/mdz404. No abstract available.
- Individual participant dataSharing planned: No
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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.
Michail Ignatiadis, MD study chair
Jules Bordet Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palbociclib in people with Breast Cancer Female, run by Jules Bordet Institute at 5 sites in Belgium.
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 10 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. 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?
To identify biomarkers of resistance to a 4-month preoperative treatment of palbociclib plus endocrine therapy defined as stable or progressive disease by ultrasound (based on WHO criteria) using RNA-seq of the baseline tumour biopsy (time frame: 4 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 NCT03065621, 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 19 Apr 2023.