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    Clinical Trial Results:
    Neoadjuvant Letrozole and Palbociclib in patients with Stage II-IIIb breast cancer, HR (+) / HER2 (-) phenotype and Intermediate (18-25) or High (>25) Recurrence-Score by Oncotype-DX; analysis of RS and pathological changes at surgery.

    Summary
    EudraCT number
    		 2018-001702-28
    Trial protocol
    		 ES  
    Global end of trial date
    29 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 May 2022
    First version publication date
    28 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MedOPP199
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03819010
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medica Scientia Innovation Research (MEDSIR)
    Sponsor organisation address
    Avenida Diagonal 211, barcelona, Spain, 08018
    Public contact
    Alicia Garcia, Medica Scientia Innovation Research (MEDSIR), 34 932214135, alicia.garcia@medsir.org
    Scientific contact
    Alicia Garcia, Medica Scientia Innovation Research (MEDSIR), 932214135 932214135, alicia.garcia@medsir.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore after 6 months of treatment the ability of palbociclib in combination with letro-zole to induce global molecular changes measured by either the Oncotype DX Breast Recurrence Score® (the “Assay”) test result at surgery (post-treatment Recurrence Score® (RS) result), or pathological Complete Response (pCR) in patients with aggres-sive luminal tumors (pre-treatment RS result 18-25 or 26-100, and Ki67>20).
    Protection of trial subjects
    Standard of Care
    Background therapy
    		 Palbociclib, initially known as PD-0332991, is an oral and selective inhibitor of cyclin-dependent kinase (CDK) 4/6. CDK4 and CDK6 promote cell-cycle entry by phosphorylating retinoblastoma (Rb) protein and other proteins in order to initiate cell transition from the G1 phase to the S phase in the cell cycle.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 May 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 67
    Worldwide total number of subjects
    67
    EEA total number of subjects
    67
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    45
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between May 2019 and Dec 2019, a total of 67 patients with HR+ and HER2- MBC were enrolled at 16 sites. Eligible patients entered one of the two available Cohorts (Cohort A RS 18-25; Cohort B RS 26-100) according to RS assessment: 33 patients in Cohort A and 34 patients in Cohort B

    Pre-assignment
    Screening details
    		 - Premenopausal and postmenopausal women ≥18 years of age. - ECOG performance status ≤ 1. - Histologically confirmed infiltrating breast cancer. - Ki67 levels ≥ 20% confirmed by IHC testing. - Tumor size > 2,0 cm (T2-4 according to TNM staging system). - No metastatic disease (M0, according to TNM staging system). - Adequate organ function.

    Period 1
    Period 1 title
    Stage I (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A
    Arm description
    		 Patients with pre-treatment RS 18-25
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pablociclib + letrozole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Palbociclib: administered orally once a day for 21 days of every 28-day cycle followed by seven days off treatment. Letrozole: administered orally once daily continuously (in all days of each cycle). Patients should take palbociclib capsules with food. Patients should swallow palbociclib capsules whole and not to chew them prior to swallowing. No capsule should be ingested if it is broken, cracked, or otherwise not intact. Patients should take their dose at approximately the same time each day.

    Arm title
    		 Cohort B
    Arm description
    		 patients with pre-treatment RS 26-100.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pablociclib + letrozole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Palbociclib: administered orally once a day for 21 days of every 28-day cycle followed by seven days off treatment. Letrozole: administered orally once daily continuously (in all days of each cycle). Patients should take palbociclib capsules with food. Patients should swallow palbociclib capsules whole and not to chew them prior to swallowing. No capsule should be ingested if it is broken, cracked, or otherwise not intact. Patients should take their dose at approximately the same time each day.

    Number of subjects in period 1
    		Cohort A Cohort B
    Started
    33
    34
    Completed
    33
    34

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A
    Reporting group description
    		 Patients with pre-treatment RS 18-25

    Reporting group title
    Cohort B
    Reporting group description
    		 patients with pre-treatment RS 26-100.

    Reporting group values
    		 Cohort A Cohort B Total
    Number of subjects
    		 33 34 67
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 21 24 45
        From 65-84 years
    		 12 10 22
    Gender categorical
    Units: Subjects
        Female
    		 33 34 67
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all patients who received at least one dose of study medication and were evaluable for primary endpoints (biological stabilization or response)

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients that accomplish selection criteria, receive at least one drug exposure, and receive the protocol required study drug exposure and processing. Criteria for determining the “per protocol” group assignment would be established by the Steering Committee before the statistical analysis begins.

    Subject analysis set title
    Cohort A
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with pre-treatment RS 18-25

    Subject analysis set title
    Cohort B
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with pre-treatment RS 26-100.

    Subject analysis sets values
    		 FAS Per protocol Cohort A Cohort B
    Number of subjects
    67
    65
    33
    34
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    24
    21
        From 65-84 years
    10
    10
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    67
    65
    33
    34
        Male
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Cohort A
    Reporting group description
    		 Patients with pre-treatment RS 18-25

    Reporting group title
    Cohort B
    Reporting group description
    		 patients with pre-treatment RS 26-100.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all patients who received at least one dose of study medication and were evaluable for primary endpoints (biological stabilization or response)

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients that accomplish selection criteria, receive at least one drug exposure, and receive the protocol required study drug exposure and processing. Criteria for determining the “per protocol” group assignment would be established by the Steering Committee before the statistical analysis begins.

    Subject analysis set title
    Cohort A
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with pre-treatment RS 18-25

    Subject analysis set title
    Cohort B
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with pre-treatment RS 26-100.

    Primary: Primary Endpoint A

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    End point title
    		 Primary Endpoint A
    End point description
    Percentage of patients in cohort A that experience a stable RS result as measured by the Assay after 6 months of treatment: from pre-treatment RS 18-25 to post-treatment RS≤25 or the percentage of patients with pre-treatment RS 18-25 or 26-100 that experience a biological response after 6 months of treatment defined by pCR (invasive) or microscopic residual infiltration where the post-treatment RS result is not feasible (reviewed by an independent pathologist).
    End point type
    Primary
    End point timeframe
    After 6 months of treatment
    End point values
    		 Cohort A Cohort B FAS Cohort A
    Number of subjects analysed
    33
    34
    67
    33
    Units: Percentage of patients
    33
    34
    67
    33
    Statistical analysis title
    		 Co-Primary Efficacy Analysis
    Statistical analysis description
    Percentage of patients in cohort A that experience a stable RS result as measured by the Assay after 6 months of treatment. IMPORTANT: please note that this is a single-arm study with no comparator arm. The number of subjects stated for the statistical analysis does not account for this design and is therefore stated as twice as high as the correct number of patients.
    Comparison groups
    Cohort A v Cohort A
    Number of subjects included in analysis
    66
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.7337
    Method
    		 exact binomial test
    Confidence interval

    Primary: Primary Endpoint B

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    End point title
    		 Primary Endpoint B
    End point description
    The percentage of patients in cohort B that experience a change in RS result after 6 months of treatment: from pre-treatment RS 26-100 to post-treatment RS≤25; or The percentage of patients with pre-treatment RS 18-25 or 26-100 that experience a biological response after 6 months of treatment defined by pCR (invasive) or microscopic residual infiltration where the post-treatment RS result is not feasible (reviewed by anindependent pathologist).
    End point type
    Primary
    End point timeframe
    After 6 months of treatment
    End point values
    		 Cohort A Cohort B FAS Cohort B
    Number of subjects analysed
    33
    34
    67
    34
    Units: Percentage of pacients
    33
    34
    67
    34
    Statistical analysis title
    		 Co-primary B efficacy analysis
    Statistical analysis description
    The percentage of patients in cohort B that experience a change in RS result after 6 months of treatment IMPORTANT: please note that this is a single-arm study with no comparator arm. The number of subjects stated for the statistical analysis does not account for this design and is therefore stated as twice as high as the correct number of patients.
    Comparison groups
    Cohort B v Cohort B
    Number of subjects included in analysis
    68
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 exact binomial test
    Confidence interval

    Secondary: ORR

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    End point title
    		 ORR
    End point description
    ORR defined as the number of patients with complete response (CR) and partial response (PR) divided by the number of patients in the analysis population. Tumor response will be defined as best response, based on local investigator’s assessment
    End point type
    Secondary
    End point timeframe
    Before end of study
    End point values
    		 FAS
    Number of subjects analysed
    67
    Units: ORR
    67
    No statistical analyses for this end point

    Secondary: Reduction of RS

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    End point title
    		 Reduction of RS
    End point description
    The percentage of patients that experience a change in RS result, as measured by median absolute value or median percentage after 6 months of treatment from pre-treatment RS 18-25 to post-treatment RS 0- 17 for patients in Cohort A and from pre-treatment RS 26-100 to post-treatment RS≤25 for patients in Cohort B.
    End point type
    Secondary
    End point timeframe
    After 6 months of treatment
    End point values
    		 Cohort A Cohort B FAS
    Number of subjects analysed
    33
    34
    67
    Units: Median absolute value or median % change
    33
    34
    67
    No statistical analyses for this end point

    Secondary: Change in RCB score

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    End point title
    		 Change in RCB score
    End point description
    The percentage of patients that experience change in RCB score, which is calculated combining pathologic measurements of primary tumor (size and cellularity) and nodal metastases (number and size) from pre-treatment score of II-III to post-treatment score of 0-I for both Cohorts of patients.
    End point type
    Secondary
    End point timeframe
    After 6 months of treatment
    End point values
    		 FAS
    Number of subjects analysed
    67
    Units: RCB score
    67
    No statistical analyses for this end point

    Secondary: Change in Ki67

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    End point title
    		 Change in Ki67
    End point description
    The percentage of patients that experience a change in Ki67: from Ki67 ≥ 20 to <2.7 for both Cohorts of patients evaluated on surgical resected sample post-treatment (reviewed by an independent pathologist).
    End point type
    Secondary
    End point timeframe
    After 6 months of treatment
    End point values
    		 FAS
    Number of subjects analysed
    67
    Units: Ki67
    67
    No statistical analyses for this end point

    Secondary: RS and RCB decrease in cohort B

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    End point title
    		 RS and RCB decrease in cohort B
    End point description
    Rate of patients in Cohort B for whom the RS result (from pre-treatment RS 26-100 to post-treatment RS≤25) and RCB score (from core II-III to 0-I) decrease; RCB score is calculated combining pathologic measurements of primary tumor and nodal metastasis.
    End point type
    Secondary
    End point timeframe
    After 6 months of treatment
    End point values
    		 Cohort A Cohort B
    Number of subjects analysed
    33
    34
    Units: RS and RCB score
    33
    34
    No statistical analyses for this end point

    Secondary: RS change in cohort A

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    End point title
    		 RS change in cohort A
    End point description
    Rate of patients in Cohort A for whom the RS increases (from pre-treatment RS 18-25 to post- treatment RS 26-100).
    End point type
    Secondary
    End point timeframe
    After 6 months of treatment
    End point values
    		 Cohort A Cohort B
    Number of subjects analysed
    33
    34
    Units: RS change
    33
    34
    No statistical analyses for this end point

    Secondary: Molecular changes

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    End point title
    		 Molecular changes
    End point description
    The concordance rate among post-treatment RS results, pCR (lack of signs of cancer), RCB, and PEPI scores; the latter is calculated combining assessment of tumor size, nodal involvement, HR status and Ki67 levels.
    End point type
    Secondary
    End point timeframe
    After 6 months of treatment
    End point values
    		 FAS
    Number of subjects analysed
    67
    Units: Concordance rate
    67
    No statistical analyses for this end point

    Secondary: Determination of Ki67

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    End point title
    		 Determination of Ki67
    End point description
    Percentage of patients with Ki67>10% and Ki67<2.7 evaluated on tissue biopsy at 14 days.
    End point type
    Secondary
    End point timeframe
    At 14 days
    End point values
    		 FAS
    Number of subjects analysed
    67
    Units: Ki67
    67
    No statistical analyses for this end point

    Secondary: change in RS

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    End point title
    		 change in RS
    End point description
    Median absolute value or median percentage of change in RS result from pre-treatment to post- treatment RS results in both Cohorts of patients after 6 months of treatment.
    End point type
    Secondary
    End point timeframe
    After 6 months of treatment
    End point values
    		 FAS
    Number of subjects analysed
    67
    Units: RS change
    67
    No statistical analyses for this end point

    Secondary: MTS

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    End point title
    		 MTS
    End point description
    MTS (maximum tumor shrinkage) defined as the percentage of tumor shrinkage from baseline, based on local investigator’s assessment
    End point type
    Secondary
    End point timeframe
    After 6 months of treatment
    End point values
    		 FAS
    Number of subjects analysed
    67
    Units: MTS
    67
    No statistical analyses for this end point

    Secondary: breast conserving surgery

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    End point title
    		 breast conserving surgery
    End point description
    To determine the rate of breast conserving surgery.
    End point type
    Secondary
    End point timeframe
    Before end of study
    End point values
    		 FAS
    Number of subjects analysed
    67
    Units: rate of breast conserving surgery
    67
    No statistical analyses for this end point

    Secondary: AEs

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    End point title
    		 AEs
    End point description
    Adverse events (AEs), which will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (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 drug combination.
    End point type
    Secondary
    End point timeframe
    Before end of study
    End point values
    		 FAS
    Number of subjects analysed
    67
    Units: number of AEs
    67
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The reporting started on the first patient first dose (26th of February 2019) The cut-off date for all safety analyses was 26th of October 2020.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 67 (4.48%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infected seroma
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 67 (91.04%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Hot flush
         subjects affected / exposed
    9 / 67 (13.43%)
         occurrences all number
    9
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    19 / 67 (28.36%)
         occurrences all number
    26
    Axillary pain
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    7 / 67 (10.45%)
         occurrences all number
    9
    influenza-like illness
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Mucosal dryness
         subjects affected / exposed
    4 / 67 (5.97%)
         occurrences all number
    4
    Oedema
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vulvovaginal dryness
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Epistaxis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    4 / 67 (5.97%)
         occurrences all number
    4
    Nervousness
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Investigations
    Alanina aminotransferasa increased
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    3
    Blood calcium increased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    5 / 67 (7.46%)
         occurrences all number
    9
    Glomerular filtration rate decreased
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    4
    Glomerular filtration rate increased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    5 / 67 (7.46%)
         occurrences all number
    5
    Hypersomnia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 67 (7.46%)
         occurrences all number
    6
    Leukopenia
         subjects affected / exposed
    10 / 67 (14.93%)
         occurrences all number
    21
    Neutropenia
         subjects affected / exposed
    43 / 67 (64.18%)
         occurrences all number
    118
    Thrombocytopenia
         subjects affected / exposed
    5 / 67 (7.46%)
         occurrences all number
    6
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Retinal tear
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    5 / 67 (7.46%)
         occurrences all number
    6
    Dry Mouth
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Gastroesophageal reflux disease
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Odynophagia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Oesophagitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    2
    Rectal tenesmus
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    15 / 67 (22.39%)
         occurrences all number
    20
    Toothache
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Blister
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Pruritus generalised
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Rash vesicular
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Renal and urinary disorders
    Nephropathy
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Renal pain
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 67 (8.96%)
         occurrences all number
    7
    Back pain
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Bone pain
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Muscle rigidity
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    4 / 67 (5.97%)
         occurrences all number
    4
    Myalgia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Tooth abscess
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2019
    - Changes in efficacy secondary objectives. - Changes in inclusion criteria. - Changes in exclusion criteria. - Changes in study procedures. - Changes in statistic design. - Changes in treatment study. - Changes in study procedures.
    19 Aug 2019
    Changes in statistic design. There will be no interruption in recruitment while the interym analysis is performing.
    12 Dec 2019
    - We have specified in more detail the primary analyses. - New toxicity related to Palbociclibmamage :Intersticial lung Disease or Pneumonitis

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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