AzTrials
AzTrials

Advanced Breast Cancer FemalePhase 3NCT02600923

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

A Phase 3 study testing Palbociclib and Letrozole in people with Advanced Breast Cancer Female, run by Pfizer at 24 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Breast Cancer Female
What is being tested?
Palbociclib and Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
24 sitesin 4 countries
Study dates
15 Apr 2016to 28 May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • Adequate bone marrow function.
  • Adequate liver function
  • Adequate renal function.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

24 sites in 4 countries.

24 sites in 4 countries

Argentina7 sites

  • Sanatorio Guemes

    CABA, C1180AAX

  • Hospital Italiano de Buenos Aires

    CABA, C1181ACH

  • Hospital Britanico de Buenos Aires

    CABA, C1280AEB

  • Instituto Medico Especializado Alexander Fleming

    CABA, C1426ANZ

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe Province, S2000KZE

  • Instituto de Cardiologia y Cirugia Cardiovascular

    Santa Fe, S3000EPV

  • ISIS Centro Especializado

    Santa Fe, S3000FFU

Other trials in Argentina

Brazil6 sites

  • Hospital Da Cidade De Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Hospital Sao Lucas da PUCRS / Uniao Brasileira de Educacao e Assistencia

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Oncologia Rede D'Or S.A.

    Rio de Janeiro, 22271-110

  • IDOR - Instituto D'Or em Pesquisa e Ensino

    Rio de Janeiro, 22281-100

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308-050

  • Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda

    São Paulo, 01317-000

Other trials in Brazil

Colombia6 sites

  • Administradora Country

    Bogotá, Bogota D.C., 11001000

  • Oncology Center

    Bogotá, Bogota D.C., 110221162

  • Instituto de Cancerologia S.A.

    Medellín, Antioquia, 050034

  • Oncomedica S.A.

    Montería, Departamento de Córdoba, 230003

  • Imagenes Diagnosticas

    Pereira, Risaralda Department, 660001

  • ONCOLOGOS DEL OCCIDENTE S.A.S Sede Pereira Clinica de Alta Tecnologia Maraya

    Pereira, Risaralda Department, 660001

Other trials in Colombia

Mexico5 sites

  • Fucam A.C.

    Coyoacán, D.F., 04890

  • Hospital Maria Auxiliadora

    Guadalajara, Jalisco, 44540

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Instituto Nacional de Cancerologia

    Tlalpan, D.F., 14080

  • Clinica de Especialidades Medicas Intepro, ONCE Oncologia Especializada

    Zapopan, Jalisco, 45030

Other trials in Mexico

About this study

Official title: 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.

Being tested
Palbociclib, Letrozole
Keywords
palbociclib, ibrance, breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    Also called Ibrance

    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).

  • LetrozoleDrug

    Also called Femara

    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.

Study groups in NCT02600923
Study groupRoleWhat they receive
Palbociclib + LetrozoleExperimentalpalbociclib and letrozole combination
Receives: Drug: Palbociclib; Drug: Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs)

    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.

    Measured: 3 years

  2. Number of Participants With Palbociclib-related TEAEs

    An 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 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. Palbociclib-related TEAEs were determined by the investigator.

    Measured: 3 years

  3. Number of Participants With Serious Adverse Events (SAEs)

    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. AEs included both SAEs and AEs. Palbociclib-related SAEs were determined by the investigator.

    Measured: 3 years

Secondary outcomes (2)

  1. Number of Participants With Death

    Death from any cause while on treatment and within 28 days of palbociclib discontinuation was only counted below.

    Measured: 3 years

  2. The Objective Response Rate (ORR)

    The tumor response was based on the response reported by investigator per local practice. No response confirmation was applied. ORR was defined as the percentage of participants with complete response or partial response relative to all as-treated population.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2015 (estimated)
  2. Study start15 Apr 2016
  3. Primary completion28 May 2019
  4. Study completion28 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Masking
None (open label)
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02600923
Sponsor's protocol ID
A5481053
Status last verified
Jan 2022
First submitted
6 Nov 2015
Last updated
20 Jan 2022
Data monitoring committee
No
Individual data sharing
Yes: 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/data\_requests.

Publications

  • Fein L, Lazaretti N, Chuken YL, Benfield JRGR, Mano MS, Lobaton J, Korbenfeld E, Damian F, Lu DR, Mori A, Patyna SJ, Franco S. Expanded Access Study of Palbociclib Plus Letrozole for Postmenopausal Women with HR+/HER2- Advanced Breast Cancer in Latin America for Whom Letrozole Therapy is Deemed Appropriate. Clin Drug Investig. 2023 Sep;43(9):699-706. doi: 10.1007/s40261-023-01294-3. Epub 2023 Aug 18.

    PubMed 37594640

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palbociclib and Letrozole in people with Advanced Breast Cancer Female, run by Pfizer at 24 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Argentina, Brazil, Colombia, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs) (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02600923, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in