← Back to Search

Monoclonal Antibodies

Continued Palbociclib Treatment for Breast Cancer

Phase 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 28 days after last dose of study intervention

Awards & highlights

Study Summary

This trial seeks participants to receive treatment and be monitored to determine the safety of study medicine(s). They must have completed a parent study, agree to reproductive criteria, and consent to the study.

Who is the study for?

This trial is for people who are already taking part in a Pfizer palbociclib study and seeing benefits. They must be able to follow the study's rules, including reproductive guidelines, attend all visits, and stick to treatment plans. Participants need to sign a consent form agreeing to these terms.Check my eligibility

What is being tested?

Participants will continue receiving Letrozole, Palbociclib, Cetuximab, or Fulvestrant as they did in the previous palbociclib studies. The focus is on monitoring safety and understanding how well these medicines work over an extended period after the initial study has ended.See study design

What are the potential side effects?

While specific side effects aren't listed here, ongoing monitoring will assess any adverse reactions from continued use of Letrozole, Palbociclib, Cetuximab or Fulvestrant. These could include issues previously identified during the parent study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 28 days after last dose of study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 28 days after last dose of study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 28 days after last dose of study intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 4Experimental Treatment2 Interventions

Palbociclib plus Letrozole

Group II: Arm 3Experimental Treatment2 Interventions

Palbociclib plus Fulvestrant

Group III: Arm 2Experimental Treatment2 Interventions

Palbociclib plus Cetuximab

Group IV: Arm 1Experimental Treatment1 Intervention

Cetuximab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole

2002

Completed Phase 4

~3240

Palbociclib

2017

Completed Phase 3

~3760

Cetuximab

2011

Completed Phase 3

~2480

Fulvestrant

2011

Completed Phase 3

~3690

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,947 Total Patients Enrolled

111 Trials studying Breast Cancer

36,409 Patients Enrolled for Breast Cancer

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,165 Total Patients Enrolled

42 Trials studying Breast Cancer

12,773 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is Arm 1 a secure experience for participants?

"Our team has assigned Arm 1 a score of 2, as it is currently in Phase 2 and there are sufficient data to confirm its safety but not yet enough evidence to prove efficacy."

Answered by AI

Is recruitment for this trial ongoing at the moment?

"According to the clinicaltrials.gov platform, this medical experiment is currently recruiting patients. It was originally published on July 7th 2022 and its listing was most recently modified on September 25th 2023."

Answered by AI

How many participants have signed up to participate in this research project?

"This clinical trial needs 35 patients who fulfill its eligibility criteria. Participants can be recruited from Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council in Dnipro, Seoul-teukbyeolsi [Seoul], and National Cancer Center in Goyang-si, Chernivetska Oblast."

Answered by AI

How widely dispersed are the sites offering this clinical study throughout the state?

"This study has recruited patients from Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council in Dnipro, Seoul-teukbyeolsi [seoul], National Cancer Center in Goyang-si, Chernivetska Oblast, and Samsung Medical Center in Chernivtsi, California to name a few 8 additional sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies

2022. "Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05226871.