You are here

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

Last updated on August 10, 2018

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate
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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Breast Cancer Female
  • 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
Experimental: Palbociclib + Letrozole
palbociclib and letrozole combination
Interventions:
  • Drug: Palbociclib
  • Drug: Letrozole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
October 31, 2018
October 31, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Argentina,   Brazil,   Colombia,   Mexico
 
 
NCT02600923
A5481053
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now