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Letrozole for Breast Cancer

Phase 3

Waitlist Available

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 from date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-nov-2021, approximately 8.7 years)

Awards & highlights

Study Summary

This trial will compare the effectiveness of letrozole + PD-0332991 vs letrozole + placebo at treating ER+/HER2- advanced breast cancer in postmenopausal women who haven't received prior systemic therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-nov-2021, approximately 8.7 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-nov-2021, approximately 8.7 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-nov-2021, approximately 8.7 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression-Free Survival (PFS) as Assessed by the Investigator.

Secondary outcome measures

Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index

Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)

Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PD-0332991 + LetrozoleExperimental Treatment2 Interventions

PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).

Group II: Placebo + LetrozoleActive Control2 Interventions

Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole

2002

Completed Phase 4

~3240

PD-0332991

2013

Completed Phase 3

~1180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,208 Total Patients Enrolled

111 Trials studying Breast Cancer

36,404 Patients Enrolled for Breast Cancer

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,092,376 Total Patients Enrolled

43 Trials studying Breast Cancer

12,808 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.

What other studies have included Letrozole as a variable?

"Currently, 266 clinical trials are investigating Letrozole with 53 of those in Phase 3. Most studies for Letrozole are based out of Burgas, New jersey; however, there are 16544 total locations running trials for Letrozole."

Answered by AI

What does Letrozole typically help with?

"Letrozole is most frequently used to combat cancerous growths. Additionally, it can be useful in the treatment of other conditions such as advanced breast cancer that is hormone receptor positive and HER2 negative, cycles without ovulation, and prior endocrine therapy."

Answered by AI

To date, how many total individuals have enrolled in this research project?

"Unfortunately, this study has closed recruitment. Candidates were last being accepted on October 10th, 2022. However, there are still 2370 trials for breast cancer and 266 for Letrozole admitting patients."

Answered by AI

Can you give me a number of places where this research is taking place?

"There are 100 clinical trial sites for this medication, including The Emory Clinic in Atlanta, Sylvester at Deerfield Beach in Deerfield Beach, and Memorial Hospital West in Pembroke Pines."

Answered by AI

Has the Federal Drug Administration greenlit Letrozole?

"According to our team's assessment, letrozole scores a 3 in terms of safety. This is due to the fact that it is a phase 3 trial, which means there is some data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Are there any more spots open for people to sign up for this experiment?

"Unfortunately, this particular study is no longer recruiting patients. Although it was originally posted on February 22nd 2013 and last updated on October 10th 2022, there are other medical trials with open recruitment at the moment. 2636 to be exact."

Answered by AI