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Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate

Last updated on December 8, 2019

FOR MORE INFORMATION
Study Location
Instituto de Oncologia de Rosario
Rosario, Santa FE, S2000KZE Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Breast Cancer Female
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02600923
Pfizer
Completed
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate

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Descriptive Information
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
  • Drug: Palbociclib
    Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1).
    Other Name: Ibrance
  • Drug: Letrozole
    Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
    Other Name: Femara
Study Arms  ICMJE Experimental: Palbociclib + Letrozole
palbociclib and letrozole combination
Interventions:
  • Drug: Palbociclib
  • Drug: Letrozole
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
 (submitted: February 1, 2019)
131
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2015)
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:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
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
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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