Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate
NCT02600923
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- Adult women with proven diagnosis of advanced adenocarcinoma of the breast (locoregional recurrent or metastatic disease).
- Women who are not of childbearing potential.
- ER-positive and/or Progesterone receptor (PgR)-positive tumor based on local laboratory results (test as per local practice).
- HER2-Negative breast cancer based on local laboratory results (test as per local practice or local guidelines).
- Patients must be appropriate candidates for letrozole therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate bone marrow function.
- Adequate liver function
- Adequate renal function.
- Known hypersensitivity to letrozole, or any of its excipients, or to any palbociclib
excipients.
- Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
isoenzymes within 7 days prior to study entry.
- Prior treatment with any CDK inhibitor.
- Previous participation in a palbociclib clinical study.
- Participation in other studies involving investigational drug(s) within 2 weeks prior
to study entry and/or during study participation.
- QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc
prolongation, or Torsade de Pointes.
- High cardiovascular risk, including, but not limited to recent myocardial infarction,
severe/unstable angina and severe cardiac dysrhythmias in the past 6 months prior to
enrollment.
- Diagnosis of any second invasive malignancy within the last 3 years prior to
enrollment. Note: patients with adequately treated basal cell or squamous cell skin
cancer, a history of intraepithelial neoplasia or in situ disease (eg, carcinoma in
situ of the cervix or melanoma in situ) may enter.
- Active uncontrolled or symptomatic brain metastases. Previously treated and
clinically stable, brain metastases are permitted.
- Other severe acute or chronic medical or psychiatric conditions.
- Patients who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
investigator, or patients who are Pfizer employees directly involved in the conduct
of the study.
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Descriptive Information | |||||||
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Brief Title ICMJE | Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate | ||||||
Official Title ICMJE | STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE | ||||||
Brief Summary | The purpose of this study is to provide access to palbociclib in Mexico and in selected Latin American countries before it becomes commercially available to patients with HR positive/HER2-negative ABC who are appropriate candidates for letrozole therapy. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Advanced Breast Cancer Female | ||||||
Intervention ICMJE |
| ||||||
Study Arms ICMJE | Experimental: Palbociclib + Letrozole
palbociclib and letrozole combination Interventions:
| ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 131 | ||||||
Original Estimated Enrollment ICMJE | 130 | ||||||
Actual Study Completion Date ICMJE | May 28, 2019 | ||||||
Actual Primary Completion Date | May 28, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Argentina, Brazil, Colombia, Mexico | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02600923 | ||||||
Other Study ID Numbers ICMJE | A5481053 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |