NCT02679755|CompletedPhase 4Results

Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

A STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE

Pfizer ClinicalTrials.gov

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1 other identifier

A5481037

Study Type

interventional

Target

252

Locations

2 countries

Sites

Timeline

RegisteredFeb 2016

StartedMar 2016

CompletionJul 2019

Brief Summary

A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

252

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline

Completed

Started Mar 2016

Typical duration for phase_4 breast-cancer

Geographic Reach

2 countries

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.4 years study duration

First Submitted

Initial submission to the registry

January 22, 2016

Completed

19 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed

28 days until next milestone

Study Start

First participant enrolled

March 9, 2016

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2019

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

October 5, 2020

Completed

Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

3.4 years

First QC Date

January 22, 2016

Results QC Date

July 31, 2020

Last Update Submit

July 26, 2022

Conditions

Breast Cancer

Keywords

Hormone receptor positive advanced breast cancer

Outcome Measures

Primary Outcomes (5)

Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as treatment emergent adverse events (TEAEs). AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Palbociclib-related TEAEs were determined by the investigator.
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. Palbociclib-related TEAEs were determined by the investigator.
Baseline up to 28 days after last dose of study treatment, an average of 14 months
Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related)
An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Palbociclib-related SAEs were determined by the investigator.
Baseline up to 28 days after last dose of study treatment, an average of 14 months

Secondary Outcomes (6)

Percentage of Participants With Complete Response and Partial Response
Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
The Objective Response Rate (ORR)
Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year
EQ-5D Health Utility Index Score
The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.
Change From Baseline in EQ-5D Health Utility Index Score
The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.
EQ-VAS Score
The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.
+1 more secondary outcomes

Study Arms (1)

Experimental arm

EXPERIMENTAL

Palbociclib plus Letrozole

Drug: PalbociclibDrug: Letrozole

Interventions

PalbociclibDRUG

125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles

Also known as: IBRANCE

Experimental arm

LetrozoleDRUG

2.5 mg/d tablets orally on a continuous regimen

Experimental arm

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Post-menopausal women (\>=18 years of age) with proven diagnosis of advanced carcinoma of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole therapy (in the first-line advanced/metastatic disease setting).
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Adequate bone marrow, liver, and renal function.

You may not qualify if:

Prior treatment with any CDK inhibitor .
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 myocardial infarction, severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary embolism in the past 6 months of enrollment.

Contact the study team to confirm eligibility.