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A Phase II Randomized Study Evaluating the Biological and Clinical Effects ... | Not Recruiting
A Phase II Randomized Study Evaluat... | Not Recruiting
A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer
PALLET

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Medical Conditions
  • Breast Cancer
  • Breast Carcinoma
  • Breast Tumors
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02296801
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal women with ER-positive/HER2-negative breast cancer.
Research Details
  • The FB-11 study is a Phase II, randomized, open label, four arm study to examine the biological and clinical effect of neoadjuvant letrozole with or without palbociclib in the first-line treatment of estrogen-receptor (ER) positive, HER2-negative early invasive breast cancer. The co-primary aims of this study are to to compare the changes in the proliferation marker Ki67, and to compare clinical response after 14 weeks of therapy with letrozole with or without palbociclib.

    The FB-11 study initiative is a joint partnership between the NSABP Foundation, Inc. (NSABP) Department of Site and Study Management (DSSM) and United Kingdom (UK) co-investigators at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research (ICR). Parallel protocols will be conducted in the US and Canada (FB-11), and the UK (PALLET) with joint analysis of interim and final data.

    Postmenopausal women, newly diagnosed with ER-positive/HER2-negative early breast cancer, who are suitable candidates for neoadjuvant endocrine therapy will be invited to join the FB-11/PALLET trial. Approximately 306 patients will be accrued to this study. Each collaborative group will recruit at least 1/3 and no more than 2/3 of the target accrual.

    Patients will be randomized to one of four treatment arms (3:2:2:2 ratio). Treatment in the first 14 weeks of neoadjuvant therapy will be:Arm A Letrozole alone; Arm B Letrozole for 2 weeks followed by letrozole + palbociclib to week 14; Arm C Palbociclib for 2 weeks followed by letrozole + palbociclib to week 14; Arm D Letrozole + palbociclib to week 14.

    Letrozole will be administered orally as a 2.5mg daily tablet. Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 day] cycle.

    The end of study therapy for patients in Arm A will be completion of week 14. Patients in Arms B, C, and D will complete study therapy following 14 days of palbociclib in the final treatment cycle past 14 weeks if treatment delays have occurred.

    Note: After week 14 (end of study therapy) all patients should continue letrozole until surgery. Letrozole is not considered study therapy beyond completion of week 14 for Arm A or after 14 days of palbociclib in the final treatment cycle for patients in Arms B, C, and D.

    Following completion of study therapy, surgery will be scheduled for 15-18 weeks post-randomization. Post-surgical treatment will be at discretion of treating clinician, following local protocols, and not influenced by allocation of treatment within the FB-11/PALLET study.

    Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Letrozole, Drug : palbociclib

Study Arm Groups : A: letrozole, B: letrozole then letrozole + palbociclib, C: palbociclib then letrozole + palbociclib, D: letrozole + palbociclib, B: letrozole then letrozole + palbociclib, C: palbociclib then letrozole + palbociclib, D: letrozole + palbociclib

Intervention Type
See Interventions above
Primary Outcome Measures
    Measurement of the proliferation marker Ki67 (% positive tumor cells); Baseline and at 14 weeks; Clinical Complete Response (cCR): Number of patients who have resolution of measurable lesions or no new lesions or other signs of disease progression compared to baseline.; Baseline and at 14 weeks
Secondary Outcome Measures
    Pathological Complete Response (pCR): Number of patients with no lesions in breast and nodes at time of surgery; 14 weeks; Preoperative Endocrine Prognostic Index (PEPI) score:; 14 weeks; Number and severity of adverse events; baseline and weekly through 12 months after randomization; Molecular and genetic profiles of samples collected.; Baseline, week 2 and week 14; Measurement of Ki67 marker; Week 2 and week 14
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
306
Participant Inclusion Criteria
    Inclusion Criteria:

    - Patients must be postmenopausal women defined as: Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or Age 55 or younger with no menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Age greater than or equal to 18 with documented bilateral oophorectomy.

    - Operable ER-positive/HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment. HER2-negative as determined by American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines.

    - No known severe hypersensitivity reactions to compounds similar to palbociclib or palbociclib excipients or to endocrine treatments.

    - A breast tumor with an ultrasound size of at least 2.0 cm.

    - Patients must have the ability to swallow oral medication.

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    - At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL.

    - international normalized ratio (INR) must be within normal limits of the local laboratory ranges.

    - The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be must be less than or equal to 1.5 x ULN for the lab; and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab.

    - Serum creatinine performed within 4 weeks prior to study entry must be less than or equal to 1.25 x ULN or estimated creatinine clearance less than 60 mL/min (as calculated using the method standard for the institutions).

    Exclusion Criteria:

    - Active hepatitis B or hepatitis C with abnormal liver function tests.

    - HIV positive patients receiving antivirals.

    - Premenopausal or peri-menopausal women.

    - Inflammatory/inoperable breast cancer.

    - HER2-positive as determined using ASCO-CAP Guidelines.

    - Concurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken) of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogens)

    - Prior endocrine therapy for breast cancer.

    - Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ).

    - Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up such as: Active infection or chronic infection requiring chronic suppressive antibiotics; Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function; Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids); Seizure disorders requiring medication.

    - Diagnosis by fine needle aspiration (FNA) alone or excisional biopsy or lumpectomy performed prior to study entry.

    - Surgical axillary staging procedure prior to study procedure (with exception of FNA or core biopsy).

    - Definitive clinical or radiologic evidence of metastatic disease.

    - History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiotherapy or contralateral invasive breast cancer at any time.

    - Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.

    - Use of any medication or substances that are strong inhibitors or inducers of CYP3A isoenzymes.

    - Class III or Class IV myocardial disease as described by the New York Heart Association; a recent history (within 6 months) of myocardial infarction, or symptomatic arrhythmia at the time of randomization. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Such patients are comfortable at rest. Less than ordinary physical activity that causes fatigue, palpitation, dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to perform any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest.

    - QTc greater than 480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or know history of QTc prolongation, or Torsade de Pointes (TdP).

    - The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
SW3 6JJ
London
W8 6RF
Leeds
LS9 7TF
London
EN5 3DJ
Milton Keynes
Buckinghamshire
MK6 5LD
Huntingdon
Cambridgeshire
PE29 6NT
Truro
Cornwall
TR1 3LQ
Exeter
Devon
EX2 5DW
Brighton
East Sussex
BN2 5BE
Westcliffe-on-sea
Essex
SS0 0RY
Dartford
Kent
DA2 8DA
Maidstone
Kent
ME16 9QQ
Liverpool
Merseyside
L7 8XP
Great Yarmouth
Norfolk
NR31 6LA
Taunton
Somerset
TA1 5DA
Weston-Super-Mare
Somerset
BS23 4TQ
Sutton
Surrey
SM2 5PT
Salisbury
Wiltshire
SP2 8BJ
Kidderminster
Worcestershire
DY11 6RJ
Redditch
Worcestershire
B98 7UB
Worcester
Worcestershire
WR5 1DD
Belfast
BT9 7AB
Bournemouth
BH7 7DW
Edinburgh
EH4 2XU
London
N19 5NF
London
NW1 2BU
Nottingham
NG5 1PB
Plymouth
PL6 8DH
Swansea
SA2 8QA
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Canada, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer
EudraCT Number
Not available for this trial
Funder(s)
  • Pfizer
  • Royal Marsden NHS Foundation Trust
  • Institute of Cancer Research, United Kingdom
Other Study ID Numbers
NSABP FB-11
Sponsor(s)
NSABP Foundation Inc
Key Dates

Recruitment Start Date

Jan 2015

Recruitment End Date

Jul 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

18 Nov 2014

Date updated in source

13 Aug 2018